| Guvnor

What this means for your business

187 obligations

74 penalties

71 can imprison

6 guides

Enforced by: MHRA
Applies to: United Kingdom
On this page: 187 compliance obligations, 6 practical guides across 2 topics

Read full text on legislation.gov.uk

What you must do

187 compliance obligations under this legislation — 71 can result in imprisonment.

Appointments 4

If you hold a manufacturer’s licence for medicinal products, you must always have at least one qualified person responsible for the duties set out in the regulations. You must notify the licensing authority whenever that person changes and you must provide the staff, premises and equipment they need to carry out their role.

Manufacturer/Importer s.41 MHRA when you hold a manufacturer's licence for medicinal products

If your business holds a licence to handle medicinal products you must always have a qualified "responsible person" on hand. This person must have the right knowledge and experience, carry out compliance and quality checks, and you must inform the regulator of any changes to that person.

Trader/Business s.45 MHRA

If your business imports medicinal products from an approved country under a wholesale dealer’s licence, you must always have a named “responsible person (import)” on the regulator’s register. That person must carry out the import duties, keep batch certification evidence and any changes must be approved through a licence variation.

Trader/Business Requirement as to responsible persons where licenc MHRA When you import medicinal products from an approved country under a wholesale …

If your business imports human medicines, you must have a named responsible person (import) who meets the required qualifications, professional memberships and experience. That person must be entered on the licensing authority’s responsible‑person (import) register before you can legally carry out the import.

Trader/Business Register for responsible persons (import) MHRA When you import human medicines and need to designate a responsible person …

Risk assessment 1

If you want a licence to make or supply medicines, you must show the regulator that your plant, equipment, staff skills and record‑keeping are suitable and secure. The authority will use these factors to decide whether to grant you a licence.

Manufacturer/Importer s.22 MHRA When applying for a manufacturer's or wholesale dealer's licence

Management duties 55

You must carry out regular audits of your drug‑safety (pharmacovigilance) system, record the main findings in the system’s master file and put in a corrective action plan as soon as reasonably practicable. When the actions are completed you can remove the note. If you hold a UK marketing authorisation you also have to follow the extra audit rules set out in Schedule 12A.

Manufacturer/Importer s.184 MHRA

If you hold a licence to manufacture or assemble medicinal products you must run a Good Manufacturing Practice (GMP) quality system, keep all batch records and samples ready for inspection, give the regulator any information it asks for, tell it straight away about changes to key personnel or the product, withhold any batch that does not meet specifications, keep detailed master‑files for each product and report any suspected adverse reactions. Failure to do so can lead to criminal prosecution.

Manufacturer/Importer Schedule 4 MHRA When you hold a manufacturer's licence for the manufacture or assembly of …

If your business manufactures, distributes or imports active pharmaceutical substances in Great Britain or Northern Ireland, you must follow the relevant good manufacturing and good distribution practice standards. For imports you also need a written statement from the exporting country's authority confirming that the product was made to standards at least equivalent to UK GMP and that the plant is regularly inspected. This helps ensure public‑health protection and keeps your licence valid.

Manufacturer/Importer Requirements for registration as an importer, manu MHRA When you manufacture, distribute or import an active substance in Great Britain …

If you hold a wholesale medicines licence, you must run your business in line with the rules on good distribution practice, keep medicines supplied so patients’ needs are met, maintain appropriate staff, premises and equipment, only sell medicines that have the required authorisations, keep detailed records and an emergency recall plan, notify the authority of any structural changes or imports, and allow inspections.

Trader/Business s.43 MHRA

If the MHRA (or another Minister) sends you a written notice deciding whether your medicine advertisement complies with the law, you must follow the instructions – either keep the ad running, stop it, or continue any existing restrictions. You also need to retain the notice and prove what action you took.

Trader/Business s.306 MHRA When you receive a new notice from the Ministers under s.306 after …

If your pharmacy works with another pharmacy that assembles or partly assembles medicines for you to sell to patients, you must have a written agreement that sets out each party’s responsibilities. You also have to display a clear notice at your premises (or on your website) showing the other pharmacy’s name, address and a brief description of the arrangement.

Trader/Business Assembly or part-assembly as part of “hub and spok MHRA When you enter into a hub‑and‑spoke dispensing arrangement with another pharmacy that …

If the MHRA (or other licensing authority) suspends or varies your manufacturing licence so that a modular unit or point‑of‑care (POC) site can no longer manufacture or assemble medicines, you must not approve that unit or site for those activities. You can only re‑approve it after you submit an application under regulation 29 and obtain permission.

Manufacturer/Importer Effect of suspension or variation relating to modu MHRA When the licensing authority suspends or varies your licence for a modular …

If your business holds a certificate of registration for a medicine, you must make sure the product is reliably available to pharmacies and other authorised suppliers so patients across the UK can get it. This means planning, monitoring and managing your production, stock and distribution to avoid shortages. Failing to keep the supply flowing could lead to regulatory action.

Manufacturer/Importer s.118 MHRA If you hold a certificate of registration for a medicine

If you hold a manufacturer’s licence, you must make sure that any manufacturing or assembly carried out at the modular units listed in your licence’s master file follows the specific requirements set out in regulation 37(2)‑(7), (9) and (11). You also have to ensure that only the medicinal products named on your licence are made at those modular units.

Manufacturer/Importer Manufacturing and assembly of MM medicinal product MHRA When manufacturing or assembling at modular units specified in the licence’s master …

If you hold a UK medicines licence and sell listed NIMAR products to Northern Ireland, you must keep the supply running, store and handle them safely, follow good distribution practice, keep detailed records, maintain a quality system, notify the authority of any changes or suspected falsified medicines, and have a recall plan ready.

Trader/Business Obligations of licence holder in Great Britain sup MHRA When your business holds a UK medicines licence and supplies listed NIMAR …

If your company holds a marketing authorisation for a medicine, you must take reasonable steps to keep the product available to pharmacies and other authorised suppliers so patients in the UK can get the medicine they need. This means actively managing stock, distribution and any foreseeable supply issues.

Manufacturer/Importer s.78 MHRA

If your business supplies a medicinal product that contains radionuclides, you must make sure that every carton, container, shielding and vial is labelled exactly as required by the regulations and the IAEA transport rules. The labels must show the radiation symbol, product name, radionuclide, batch number, expiry date, amount of radioactivity, dosage details and manufacturer contact information.

Manufacturer/Importer s.262 MHRA When your medicinal product contains radionuclides

If your business holds a manufacturer’s licence for medicines, you must follow Good Manufacturing Practice when importing products from any country that is not on the approved‑import list (for Great Britain) or any non‑EEA state (for Northern Ireland). You also need to confirm that any active substances used as starting materials in those imports were themselves produced under GMP.

Manufacturer/Importer s.38 MHRA When importing medicinal products into Great Britain from a country not on …

If your business publishes any advertisement for a homeopathic medicine that is registered, you must make sure the ad does not mention any specific therapeutic uses and only contains the information set out in Schedule 28. In practice this means checking every ad before it goes live and keeping a record that it complies.

Any Person s.301 MHRA When you publish an advertisement for a registered homeopathic medicinal product

If your business publishes advertising for any medicinal product that has a UK marketing authorisation, traditional herbal registration or Article 126a authorisation, you must make sure the advert only contains the information set out in the product’s Summary of Product Characteristics, presents the product objectively, does not exaggerate or mislead, and – for temporarily authorised products – is part of a minister‑approved campaign. Failing to do so is a criminal offence.

Any Person s.280 MHRA When publishing an advertisement for a medicinal product with a UK marketing …

If you place a medicinal product on the UK market (unless it is a registrable homoeopathic, advanced therapy or POC product), you must print the information set out in Schedule 24 on both the outer and immediate packaging. The details must be clear, easy to read and permanent, so customers can see the required safety and usage information.

Manufacturer/Importer s.257 MHRA When supplying a non‑homoeopathic, non‑advanced‑therapy, non‑POC medicinal product on the UK market

If your business holds a traditional herbal registration, you must take reasonable steps to keep the product continuously available to pharmacies and other authorised suppliers across the UK. This means planning your stock, monitoring demand and supply chains, and acting quickly if a shortage arises so that patients’ needs are met.

Manufacturer/Importer s.148 MHRA

If your business manufactures a point‑of‑care medicinal product that has a UKMA Category 1 authorisation (and is not an advanced therapy product or used straight after manufacture), you must put the specific information set out in Part 6 of Schedule 24 on the outer pack. The same information must also appear on the immediate pack unless the pack is a blister inside compliant outer packaging or is too small – in those cases the information in Part 7 of Schedule 24 must be shown on the immediate pack.

Manufacturer/Importer Packaging requirements: POC medicinal products MHRA When placing on the market a POC medicinal product with a UKMA …

If you import medicinal products into the UK, you must only bring them from countries that the MHRA has specifically approved. The approval list is checked before each import, and the list is reviewed at least every three years. Importing from an unapproved country risks breaching your licence conditions.

Trader/Business Approved country for import MHRA When you import medicinal products into the UK

If you advertise a medicinal product in Great Britain that is not prescription‑only in GB but is prescription‑only in Northern Ireland, or is not authorised there, you must tell the public that the product cannot be obtained without a prescription or is not available for sale in Northern Ireland. This statement must appear in every public advertisement for that product.

Trader/Business Medicines with differing classification status in MHRA Advertising a medicinal product in Great Britain that is not prescription‑only in …

If your business holds a certificate of registration for a medicine, you must regularly review how you make and control the product and consider any new scientific or technical developments. When you become aware that a change is needed to bring your methods in line with accepted science, you must promptly apply to the regulator to vary the certificate to reflect those changes.

Manufacturer/Importer s.114 MHRA When you become aware of scientific or technical progress that requires a …

If your company holds a UK marketing authorisation or a parallel import licence for a medicine, you must make sure the product information – such as the label, summary of product characteristics and patient leaflets – reflects the latest scientific knowledge. You need to regularly check the relevant EU and UK medicines web portals and update any information accordingly.

Manufacturer/Importer s.76 MHRA When you hold a UK marketing authorisation or parallel import licence for …

If your business holds a registration certificate for a medicinal product, you must continually ensure that the product’s information reflects the latest scientific knowledge. This means monitoring published assessments and updating the product label, leaflet and other information as soon as new data become available.

Manufacturer/Importer s.116 MHRA When you hold a certificate of registration (marketing authorisation) for a medicinal …

If you sell or supply a medicinal product that relies on the exemption in regulation 167, you must keep detailed records of each sale for at least five years after you stop supplying that product. You also have to report any suspected adverse reactions to the licensing authority – serious reactions within 15 days and non‑serious ones within 90 days – using the prescribed format, and be ready to set up a risk‑management system if the authority asks for it.

Trader/Business MM medicinal products: pharmacovigilance requireme MHRA When selling or supplying an MM medicinal product under the exemption in …

If you sell or supply a point‑of‑care (POC) medicinal product under the exemption in regulation 167, you must keep detailed records of each sale, retain them for at least five years after you stop supplying, and be ready to show them to the licensing authority. You also have to report any suspected adverse reactions – serious ones within 15 days and non‑serious ones within 90 days of becoming aware – using the required electronic format, and set up a risk‑management system if the authority asks.

Trader/Business POC medicinal products: pharmacovigilance requirem MHRA when you sell or supply a POC medicinal product relying on the …

If your company holds a traditional herbal registration for a medicinal product, you must continually check the latest scientific evidence and update the product information (e.g., label, leaflet, SPC) so it reflects that evidence. Use the European and UK medicines web‑portals as the source of the current knowledge. This ensures the information you provide to users is always accurate and compliant.

Manufacturer/Importer s.146 MHRA Your business holds a traditional herbal registration for a medicinal product

If you place a registrable homoeopathic medicinal product on the market, you must ensure that every outer pack, any blister pack inside the outer pack and any small immediate pack shows all the details set out in Schedule 28. The label must contain the scientific name and dilution, holder’s name and address, dosage instructions, expiry date, form, contents, storage warnings, batch number, registration number and the required safety warnings.

Manufacturer/Importer Schedule 28 MHRA When you place a registrable homoeopathic medicinal product on the market

If you manufacture or put a homoeopathic medicinal product on the market, you must make sure the outer pack, any immediate pack and any leaf‑let clearly say “homoeopathic medicinal product”. The only other information you may show is what is set out in the relevant parts of Schedule 28 (or Parts 2/3 where the rules for blister packs or very small packs apply). No extra text is allowed.

Manufacturer/Importer s.264 MHRA When you supply a homoeopathic medicinal product (including registrable products)

You must put a clear statement on the packaging and leaf‑let that the product is a traditional herbal medicinal product used for specific purposes because of long‑standing use, and advise users to see a doctor if symptoms persist or unexpected side‑effects occur. If the product is a pharmacy medicine being sold or supplied at retail (or distributed wholesale), the outer and immediate packaging must display a plain capital “P” inside a rectangle with no other markings.

Manufacturer/Importer Schedule 29 MHRA Applies to all traditional herbal medicinal products; the “P” symbol requirement applies …

If your company holds a UK marketing authorisation for any medicinal product, you must keep a detailed pharmacovigilance system master file (PSMF) that accurately describes your safety monitoring system. The file must contain specific information about the qualified person, organisational structure, processes, quality system, subcontractors and an annex of supporting documents, be kept under version control, and be readily accessible to the qualified person and regulators.

Manufacturer/Importer Schedule 12A MHRA When you hold a UK marketing authorisation (UKMA) for a medicinal product

If you hold a manufacturer’s licence you must run your manufacturing and assembly activities in line with Good Manufacturing Practice (GMP). This means checking the quality and authenticity of active substances and excipients, keeping the right staff, premises and equipment, only making the products listed on your licence and reporting any suspect or falsified medicines immediately.

Manufacturer/Importer s.37 MHRA when carrying out manufacture or assembly of medicinal products under a licence

If your company holds an Early Access to Medicines Scheme (EAMS) scientific opinion for a drug, you must put in place a risk‑management system, record all adverse reactions in one UK location and report serious reactions within 15 days and non‑serious reactions within 90 days. You also need to send regular safety updates, notify the regulator immediately of any new or changed risks, keep all pharmacovigilance records for at least five years after the opinion ends and provide them to the regulator on request.

Manufacturer/Importer EAMS medicinal products: pharmacovigilance MHRA When you are the holder of an EAMS scientific opinion for a …

If your company holds a UK marketing authorisation for a medicinal product, you must keep a full pharmacovigilance system master file, have a quality system for safety monitoring, use standard terminology, and regularly send electronic reports of suspected adverse reactions, safety updates and risk‑management plans in the format required by the regulator. This ensures any new or changing risks are identified and acted on promptly.

Manufacturer/Importer Further obligations in respect of pharmacovigilanc MHRA When you are the holder of a UK marketing authorisation (UKMA) or …

If you hold a manufacturer's licence you must have suitable staff, premises, equipment and processes in place to keep your medicines at the required quality. You can only handle, store or distribute medicines at the sites listed on your licence, and you must tell the licensing authority before making any material changes to those sites, the facilities, or the people responsible for quality.

Manufacturer/Importer s.39 MHRA

If your company holds a UK marketing authorisation (Category 1) for an advanced therapy medicinal product, you must set up a system that can track the product and every raw material from sourcing right through to delivery at the hospital or clinic. You also have to keep those records for at least 30 years after the product expires (or longer if the regulator tells you) and hand the data over to another party or the regulator if you go bankrupt.

Manufacturer/Importer Post authorisation requirements in relation to UKM MHRA If you hold a UK marketing authorisation (Category 1) for an advanced …

If your business holds a UK marketing authorisation, registration or similar for a medicinal product, you must set up a scientific service to gather all product information, train any medical sales representatives so they can give accurate product details, keep a copy of every advertisement together with who it was aimed at, how and when it was first published, and be ready to hand these to the Minister if they ask.

Trader/Business s.281 MHRA When you hold a UK marketing authorisation, registration, traditional herbal registration or …

If your company holds the marketing authorisation for a medicine and you plan to make a public statement about safety or side‑effect concerns, you must tell the UK licensing authority, the EMA and the European Commission before the announcement goes out. The announcement must be factual and not misleading.

Manufacturer/Importer s.205 MHRA When you intend to make a public announcement about pharmacovigilance concerns for …

If you supply a medicine under the Early Access to Medicines Scheme, you can collect data on its safety and effectiveness without a clinical‑trial licence, but only if you have written, dated consent from each patient and the licensing authority has agreed to the data collection. You must also follow any other approvals and data‑protection rules, and you cannot make patient consent a condition of getting the medicine.

Any Person Early Access to Medicines Scheme: data collection MHRA When collecting safety, quality or efficacy data on patients receiving an EAMS …

You may not make or put together a point‑of‑care (POC) medicinal product unless it is listed on your POC manufacturing licence and you have a POC master file for that product. You also have to follow the procedures set out in that master file every time you manufacture or assemble the product.

Manufacturer/Importer Manufacturing of POC medicinal products MHRA When you manufacture or assemble a POC medicinal product

You may only make or assemble a medicinal product if that product is listed on your medicines manufacturer’s licence and you have a corresponding master file for it. The licence and master file must be kept up‑to‑date and you must follow the procedures set out in the master file whenever you produce the product.

Manufacturer/Importer Manufacturing of MM medicinal products MHRA when manufacturing or assembling an MM medicinal product

If you hold a UK marketing authorisation for a medicine, you must set up and run a pharmacovigilance system. This means appointing a qualified person in the UK/EU, keeping an up‑to‑date system master file that can be inspected electronically, managing and monitoring risks, and promptly informing the MHRA of any changes or requests.

Manufacturer/Importer s.182 MHRA When you hold a UK marketing authorisation for a medicine

If your company holds a UK marketing authorisation for a medicinal product (except registrable homoeopathic products), you must put the product name in Braille on the outer (or immediate) packaging. You also have to supply the patient information leaflet in a format suitable for blind or partially‑sighted people when they ask for it.

Manufacturer/Importer s.259 MHRA When you hold a UK marketing authorisation (or Article 126a authorisation or …

If you hold a UK marketing authorisation for a medicinal product, you must produce a package leaflet that follows the Summary of Product Characteristics and includes every item set out in Schedule 27, in the correct order. The leaflet must be placed inside the packaging (unless the same information is printed on the outer pack) and must be clear, legible and easy for patients to use – you need to consult the intended patient groups when designing it.

Manufacturer/Importer s.260 MHRA When you place a medicinal product on the UK market under a …

When you place a medicinal product on the market you must show all required details on the outer and immediate packaging and in the patient information leaflet in English. You can only omit the English requirement if you get a reasoned exemption from the licensing authority (for orphan products, Article 126a authorisations, products not supplied directly to patients or where there are severe supply problems). You may add other languages as long as they contain the same information.

Manufacturer/Importer s.266 MHRA When supplying a medicinal product to the market (unless an exemption applies)

If your business is listed under the Human Medicines Regulations and you sell medicines online, you must make sure your website shows the licensing authority’s contact details and a link to its website, displays the common logo on every medicinal‑product page and links that logo to your entry on the list, and you must also meet the requirements of regulation 256B.

Trader/Business Conditions to be met by a person entered on the li MHRA You are entered on the list and sell medicinal products at a …

If your company applies for a UK marketing authorisation for a generic medicine in Northern Ireland, you must submit the information the regulator asks for under the relevant EU Directive. Once the authorisation is granted, you must make sure the product is not sold, supplied or even offered for sale in Northern Ireland until the date the authorisation allows you to place it on the market.

Manufacturer/Importer s.51 MHRA When applying for or holding a UK marketing authorisation (UKMA(NI)) for a …

If your business holds a traditional herbal medicine registration, you must continuously check that the ways you manufacture and control the product reflect the latest scientific and technical knowledge. When you discover that the methods need to be changed to meet generally accepted scientific standards, you must promptly apply to amend your registration.

Manufacturer/Importer s.143 MHRA If you hold a traditional herbal registration

If your business holds a UK marketing authorisation for a medicine, you must continually check that the way you make and control the product reflects the latest scientific and technical knowledge. As soon as you realise a change is needed, you must apply to the regulator to amend the authorisation so the product is produced using accepted scientific methods.

Manufacturer/Importer s.74 MHRA When you become aware that current manufacturing or control methods are no …

If a new herbal monograph is published that applies to one of your registered herbal medicines, you must check whether your product's registration dossier needs to be changed. If you do make any changes, you must inform the licensing authority as soon as reasonably practicable.

Manufacturer/Importer s.144 MHRA A new herbal monograph is established under the relevant EU/UK directive or …

If you sell a medicine that contains aloxiprin, aspirin, paracetamol or ibuprofen, you must make sure it is offered for sale in a single, separate package that does not exceed the maximum number of tablets, sachets, capsules, millilitres, etc., set out in Schedule 15. The limits vary by product form (e.g., 30 effervescent tablets, 16 ibuprofen tablets, 160 ml liquid paracetamol for over‑12s, etc.).

Trader/Business Schedule 15 MHRA selling a medicinal product containing aloxiprin, aspirin, paracetamol or ibuprofen in any …

If you apply for a UK marketing authorisation for a biological medicine that cannot be shown as a generic because of differences in raw materials or manufacturing, you must provide extra pre‑clinical and clinical data about those differences and follow the guidelines issued by the licensing authority. Once the authorisation is granted you may not sell the product in the UK for at least ten years (eleven years if new therapeutic indications bring a significant clinical benefit).

Manufacturer/Importer Application for UKMA(UK) relating to similar biolo MHRA Applying for a UK marketing authorisation for a similar biological medicinal product …

If you sell or distribute a radiopharmaceutical, radionuclide generator, kit or precursor, you must include a leaflet that gives the user and patient safety instructions and disposal precautions. The leaflet must contain all the details set out in Schedule 27 of the Regulations, ensuring everyone who handles the product knows how to use and dispose of it safely.

Manufacturer/Importer s.263 MHRA Whenever you supply a radiopharmaceutical, radionuclide generator, kit or precursor

If you sell or supply any regulated medicine (unless it is exempt under regulation 274), you must use a container that is dark or opaque and designed so a child cannot easily open it. The container must meet the approved British Standard (or an equivalent approved by the licensing authority) for either re‑closable or non‑re‑closable packaging.

Trader/Business s.273 MHRA When selling or supplying regulated medicinal products, except where an exemption under …

If the Medicines Licensing Authority decides your product needs to be split into a Great Britain (GB) version and a Northern Ireland (NI) version, you must change the packaging for the GB product. Specifically, replace the existing information in paragraph 18B of Schedule 24 with a statement that the medicine is for sale or supply in Great Britain only.

Manufacturer/Importer Packaging requirements: variation in accordance wi MHRA The licensing authority requires a variation under regulation 68(11I) to treat a …

When you design the outer pack or the patient leaflet for a medicinal product, you may only add symbols, diagrams or pictures that help explain the mandatory safety or dosage information or that are useful to the patient. Any picture must never be promotional. This rule does not apply to registrable homoeopathic products.

Manufacturer/Importer s.261 MHRA When producing or updating the outer packaging or package leaflet of a …

Notifications 8

If you hold a traditional herbal registration, you must tell the licensing authority when you first sell the product in the UK and do so within two months of launch. You also have to inform them before you withdraw the product (or as soon as practicable if the two‑month notice can’t be met) and report any cancellation, non‑renewal or overseas withdrawal actions, including the reasons. Finally, if the authority asks, you must supply UK sales‑volume information promptly.

Manufacturer/Importer s.142 MHRA Holding a traditional herbal registration and placing, withdrawing, cancelling, not renewing, or …

If you hold a UK marketing authorisation for a medicine, you must tell the licensing authority when you first place the product on the UK market, when you plan to withdraw it, or if you cancel, do not renew, or withdraw the product from another country for certain regulatory reasons. Notifications must be sent within two months of the event (or as soon as reasonably practicable if earlier notice isn’t possible) and must include the reasons and any information the authority requests.

Manufacturer/Importer s.73 MHRA When you place the authorised medicine on the UK market, withdraw it, …

If your company holds a certificate of registration for a human medicine, you must tell the Medicines and Healthcare products Regulatory Agency (MHRA) when the product is first sold in the UK, and again if you withdraw it. You also have to supply the MHRA with sales volume information when they ask for it. These notices must be made within the time‑frames set out in the Regulations.

Manufacturer/Importer s.113 MHRA When you place a registered medicine on the UK market, when you …

If your business wants to be officially listed as a person who can supply medicines online, you must apply to the licensing authority. The application should include your company’s name and your official UK website address, which will then be shown on the authority’s public list. Failure to apply or provide the required details can prevent your name from appearing on the list.

Any Person Grant or refusal to list a person MHRA When you wish to be added to the official list of medicine …

If your business holds a traditional herbal registration and you take urgent safety measures because of a public‑health risk, you must tell the licensing authority straight away. If the authority does not object within 24 hours, the restriction is deemed accepted. You then have to apply to vary your registration within 15 days of the restriction starting.

Manufacturer/Importer Urgent safety restrictions MHRA When a risk to public health arises and an urgent safety restriction …

If a regulator proposes to suspend, vary or delete a licence that puts your business on a required list, you must be notified in writing, give the regulator the reasons you disagree, and do this within 28 days of receiving the notice. You can also request an oral hearing. Failing to do so can result in the licence change taking effect.

Any Person Procedure where the licensing authority proposes t MHRA When the licensing authority notifies you of a proposed suspension, variation or …

If your company holds a marketing authorisation for a medicine and you are running a required post‑authorisation safety study, you must send any major changes to the study plan to the appropriate regulator before you put those changes into practice. The regulator will assess the change and tell you whether it’s approved or not, and if the change is approved by the EU/EEA pharmacovigilance committee you must also let the competent authorities in each EEA state aware of the study about the change.

Manufacturer/Importer s.200 MHRA A substantial amendment to a required safety study protocol after the study …

If a condition on your medicine’s UK marketing authorisation requires a post‑authorisation safety study, you must send a draft of the study protocol to the regulator before the study starts. You cannot commence the study until the regulator (or the PRAC where applicable) issues a letter endorsing the protocol.

Manufacturer/Importer s.199 MHRA When a post‑authorisation safety study is required under a condition of your …

Other requirements 6

If the licensing authority decides a product you have sold or may sell is a medicinal product, they can send you a notice. You must stop selling that product from the date specified in the notice until a UK marketing authorisation (or equivalent registration) is granted.

Trader/Business s.164 MHRA You receive a notice under S.164 after a final determination that the …

If a traditional herbal medicinal product has been officially suspended, you must stop selling it, supplying it or offering it for sale. You also must not arrange or help anyone else to sell or supply that product when you know, or should reasonably know, it is suspended. Put checks in place so you can verify the status of any herbal product before you trade it.

Trader/Business s.141 MHRA When a traditional herbal medicinal product is suspended under regulation 138

If a medicine has been officially suspended (its sale, supply or use is stopped), you must not sell it, supply it, or arrange for it to be sold or supplied. This also covers offering it for sale or supply. The rule applies as soon as you know, or have good reason to suspect, that the product is suspended.

Any Person s.72 MHRA When a medicinal product has been suspended under regulation 69 (i.e., its …

If you place any advertisement for a traditional herbal medicinal product that has a traditional herbal registration, you must include three exact statements: the phrase “Traditional herbal medicinal product for use in…”, a description of the therapeutic uses that match the registration, and the words “exclusively based on long standing use”. Without these, the ad is illegal.

Any Person s.302 MHRA When publishing an advertisement for a traditional herbal medicinal product with a …

If your company receives a conditional marketing authorisation for a medicine, you must make sure the product’s Summary of Product Characteristics (SmPC) and the patient‑facing package leaflet clearly state that the authorisation is conditional and show the date by which the authorisation must be renewed. This information has to be in place as soon as the authorisation is granted.

Manufacturer/Importer Consideration of applications relating to conditio MHRA When a conditional marketing authorisation is granted for a medicinal product

If you manufacture an advanced therapy medicinal product (ATMP) that is not exempt, you must put the information set out in Part 4 of Schedule 24 on the outer pack and, where applicable, on the immediate pack. When the immediate pack is a blister pack inside a compliant outer pack, or is too small to hold the Part 4 details, you must also display the Part 5 information on that immediate pack. Point‑of‑care ATMPs used straight after manufacture are excluded.

Manufacturer/Importer Packaging requirements: advanced therapy medicinal MHRA When placing a non‑exempt ATMP (not a point‑of‑care product used immediately) in …

Policies 1

If you have a UK marketing authorisation or parallel import licence for a medicine, the licence will state whether the product can only be sold by prescription, only from a pharmacy or can be sold on general sale. Your business must stick to that rule – you cannot sell the medicine in any other way. It’s a condition of the licence that you must comply with.

Trader/Business s.62 MHRA When you hold a UK marketing authorisation or parallel import licence

Offences and prohibitions 53

If you deliberately use a warranty or certificate that was issued for one medicine on a different medicine, or give a purchaser a false warranty, you commit a criminal offence under the Human Medicines Regulations. On conviction you can be fined (unlimited amount) and, on indictment, you may also face up to two years’ imprisonment. The case can be brought in the court where the sample was taken or where the warranty was given.

Any Person s.337 MHRA

If you, or anyone acting for your business, fail to comply with any requirement, prohibition or licence condition set out in the Human Medicines Regulations 2012, you commit a criminal offence. Conviction attracts penalties (fine and/or imprisonment) that are detailed in the Regulations’ penalty provisions.

Any Person s.152 MHRA

If you fail to meet any requirement, prohibition, or licensing authority order set out in the Human Medicines Regulations 2012 – for example, not following a marketing authorisation condition or ignoring a notice from the MHRA – you are committing a criminal offence. A conviction can lead to a fine and/or imprisonment, the exact penalties being detailed in the later penalty sections of the regulations.

Any Person s.98 MHRA

If your business fails to comply with the requirements set out in Commission Regulation 2016/161 (which governs certain aspects of human medicines), you commit a criminal offence. Conviction can lead to a fine – potentially unlimited – and/or imprisonment, depending on the seriousness of the breach. The offence is prosecuted by the MHRA.

Any Person Offences relating to Commission Regulation 2016/16 MHRA

If you (or your company) contravene the specific medicines regulations – for example by selling medicines at a distance outside the permitted conditions, giving false information in licensing applications or notices, ignoring a notice from the regulator, or failing to tell the licensing authority about a falsified product or a material change – you commit a criminal offence. Conviction can lead to unlimited fines and/or imprisonment, the exact penalties being set by the courts.

Any Person Offences: breach of regulations and false informat MHRA

If your business fails to comply with the obligations set out in regulation 45K (which covers certain requirements for human medicines), you commit a criminal offence. For breaches of 45K(1) or (2) you face a fine up to the statutory maximum in a magistrates’ court, or on indictment an unlimited fine, up to two years’ imprisonment, or both. For a breach of 45K(3) you face a summary‑court fine of up to £1,000.

Any Person Penalties MHRA

If you break the rules set out in regulation 175 – for example by supplying or handling human medicines outside the permitted exceptions – you commit a criminal offence. On summary conviction (Magistrates' Court) you face a fine up to the statutory maximum; on conviction on indictment (Crown Court) you can be fined and/or sentenced to up to two years’ imprisonment.

Any Person s.176 MHRA

If your company holds a UK marketing authorisation for a medicine and has already received paediatric incentives that have now expired, you must not stop supplying the product unless you first transfer the authorisation to someone who will continue supply and let them use the associated documentation, or you must give the EMA six months’ notice of termination as required by Article 35. Failing to do so is a criminal offence.

Any Person s.89 MHRA

If a member of your staff or an agent commits an offence under regulation 119 (offences related to medicine applications), you as their employer or principal are also guilty of the same offence. You can be prosecuted and will face the same penalty that would apply to the employee.

Employer s.123 MHRA

If one of your employees or agents commits an offence under regulation 150 (offences in connection with medicines applications), the employer or principal is treated as guilty of the same offence. The business can be prosecuted and punished in exactly the same way as the individual who actually committed the breach, so you must ensure staff follow the medicines regulations to avoid vicarious liability.

Employer s.154 MHRA

If a staff member or agent breaches regulation 207(1) of the Human Medicines Regulations (for example, unlawfully supplying or handling medicines), the employer or principal is also guilty of the same offence. The business can be prosecuted and punished in the same way as the individual who committed the breach, with penalties set by the underlying offence.

Employer s.211 MHRA

If you, as a holder of a medicine authorisation or any other person, do not follow any of the rules or prohibitions in the Human Medicines Regulations 2012, you commit a criminal offence. The offence can lead to prosecution, with penalties such as fines or imprisonment that are set out in other sections of the Regulations.

Any Person s.207 MHRA

If your company holds a UK marketing authorisation (or similar authorisation) for a medicinal product and the MHRA serves you a notice requiring you to meet a regulatory requirement, you must comply within the time stated. Failing to do so makes you guilty of a criminal offence, which can lead to prosecution.

Any Person s.270 MHRA

If you receive a notice from the MHRA under regulations 304, 305 or 306 and do not follow the action it requires – or if you ignore a corrective statement required under regulation 307(2) – you commit a criminal offence. On conviction you can be fined (unlimited on indictment, or up to the statutory maximum on summary conviction) and you may be jailed for up to two years. The second type of breach (under 307) is tried only in the magistrates' court and carries a fine up to level 5 on the standard scale.

Any Person s.308 MHRA

If you hold a UK marketing authorisation or a parallel import licence for a medicine and you do not meet the specific pharmacovigilance conditions set out in the relevant regulations (e.g., regulation 59, 60, 60A or 61), you commit a criminal offence. Conviction can lead to a fine and/or imprisonment, but the exact penalties are set out elsewhere in the regulations.

Any Person s.97 MHRA

If you hold a UK marketing authorisation for a medicine and you do not (a) inform the MHRA or the European Commission that you have taken urgent safety restrictions on your own initiative, (b) put those urgent safety restrictions into practice, or (c) apply to vary the authorisation within 15 days, you commit a criminal offence. Conviction can lead to a fine and/or imprisonment, but the exact penalties depend on the full regulations.

Any Person s.80 MHRA

If you hold a traditional herbal registration (THR) for Northern Ireland, the UK or Great Britain and you either do not notify the licensing authority (or the European Commission where required) when you place an urgent safety restriction on your own initiative, do not put a regulator‑imposed restriction into effect, or fail to apply to vary the registration within 15 days, you commit a criminal offence. Conviction can result in a fine (which may be unlimited) and/or a term of imprisonment.

Any Person s.149 MHRA

If you hold a parallel import licence for a medicine and you either impose an urgent safety restriction yourself, ignore a restriction imposed by the MHRA, or do not apply to vary the licence within 15 days, you commit a criminal offence. The offence can be prosecuted by the MHRA and may lead to fines and/or imprisonment. You must promptly notify the MHRA, implement any safety restrictions they order, and apply for a licence variation within the 15‑day window.

Any Person Urgent safety restrictions: parallel import licenc MHRA

If, during an application to obtain, renew or change a parallel import licence for a medicinal product, you either withhold information that is needed to assess the product’s safety, quality or efficacy, or you provide information that is false or misleading, you commit a criminal offence. This applies to any person or business making the licence application. Conviction can lead to fines and/or imprisonment, although the exact penalties are set elsewhere in the Regulations.

Any Person Offences in connection with parallel import licenc MHRA

If you submit an application to the MHRA for a licence to market a registrable homoeopathic medicinal product and you either omit information that is relevant to assessing the product’s quality, or you provide information that is false or misleading, you commit a criminal offence. On conviction you could face a fine and/or imprisonment, but the exact penalties are set elsewhere in the regulations.

Any Person s.119 MHRA

If you submit an application to the licensing authority for a new, renewed or varied marketing authorisation for a medicinal product, you must provide all information that is relevant to assessing the product's safety, quality and efficacy, and that information must be accurate. Supplying incomplete information or supplying false or misleading information is a criminal offence. A conviction can lead to unlimited fines and/or imprisonment, although the exact penalties are set elsewhere in the Regulations.

Any Person s.95 MHRA

If your company holds a manufacturer's licence for an advanced therapy medicinal product and you do not keep the required data, or you fail to pass that data to the regulator when the company goes bankrupt or into liquidation (subject to the limited exceptions), you commit a criminal offence. You may avoid conviction only by proving you took all reasonable precautions and exercised due diligence.

Manufacturer/Importer s.33 MHRA

If you do not put in place, or you breach, the risk‑management and traceability requirements for medicinal products set out in the Human Medicines Regulations, you commit a criminal offence. This applies to manufacturers, wholesalers and any other party responsible for ensuring medicines can be tracked and risks are controlled. On conviction you face an unlimited fine and/or up to six months' imprisonment.

Any Person s.87 MHRA

If your company holds a UK marketing authorisation for a medicine and does not follow the required pharmacovigilance rules – for example, keeping the system master file, maintaining quality systems, reporting suspected adverse reactions, updating risk‑management plans, submitting safety update reports or running post‑authorisation studies – or if you give false or misleading information to the regulator, you commit a criminal offence. On conviction you can be fined (unlimited amount) and, for certain serious breaches, face up to two years’ imprisonment.

Any Person Offences in relation to pharmacovigilance obligati MHRA

If your company (or any person acting on its behalf) does not fulfil the safety‑reporting duties set out in Regulation (EC) No 726/2004 – for example, failing to submit adverse‑reaction reports or periodic safety update reports – you commit a criminal offence. A conviction can lead to an unlimited fine and possibly a custodial sentence, with the case tried either in the Crown Court or, in some circumstances, the Magistrates’ Court.

Any Person s.210 MHRA

If your company holds a UK marketing authorisation for a medicine and sponsors a paediatric study, you must send the study results to the licensing authority within six months of the study ending, and any clinical trial results to the EMA within six months of the trial ending. Failing to do so is a criminal offence and can lead to prosecution.

Any Person s.93 MHRA

If you hold a UK marketing authorisation for a medicine, obtain a paediatric indication after completing the required paediatric investigation plan, and have already placed the product on the market for other uses, you must launch it for the paediatric indication within two years of that indication being authorised. Failing to do so is a criminal offence.

Any Person s.90 MHRA

If you submit an application to register, renew or vary a traditional herbal medicinal product and you either omit information that is relevant to assessing its safety, quality or efficacy, or you give information that is false or misleading, you commit a criminal offence. Conviction can result in a fine and/or imprisonment, although the exact penalties are set in other parts of the Regulations. Make sure every detail you provide to the licensing authority is complete and correct.

Any Person s.150 MHRA

If you hold a UK, NI or EU marketing authorisation, a certificate of registration or a traditional herbal registration for a medicinal product and you sell or supply that product in Northern Ireland, the packaging and any patient‑information leaflet must meet the legal requirements. It is an offence if the package or leaflet is non‑compliant, or if a required leaflet is missing. Conviction can lead to a fine and/or imprisonment (the exact penalties are set elsewhere in the regulations).

Any Person Offence relating to packaging and package leaflets MHRA

If your company holds a UK marketing authorisation for a medicinal product and you do not provide the European Medicines Agency (EMA) with the information it requires – either for authorisations granted before 2 July 2012 or for any new/changed authorisations granted on or after that date – you commit a criminal offence. Conviction can lead to a fine (which may be unlimited) and, in some cases, imprisonment.

Any Person s.79 MHRA

If you sell, supply, administer, or give a prescription or directions for a prescription‑only or otherwise regulated medicine in breach of the relevant regulations, you commit a criminal offence. Conviction can lead to an unlimited fine and up to two years’ imprisonment, while some specific breaches carry a fixed fine (level 3 on the standard scale or £400). The offence applies to anyone who deals with medicinal products in this way.

Any Person s.255 MHRA

If you intentionally block a MHRA inspector, ignore a lawful request under regulation 327, or refuse to give information the inspector reasonably needs, you commit a criminal offence. On summary conviction you face a fine of up to £1,000. No prison term is attached.

Any Person s.334 MHRA

If you sell, supply or give a specification for a medicine that falls under the special‑patient‑needs rules, you must give the licensing authority only accurate information and keep the required records. Giving false or misleading information, not keeping the records, not making them available when asked, or not reporting suspected serious adverse reactions is a criminal offence.

Any Person s.175 MHRA

If your company holds a traditional herbal medicine registration and you give the MHRA false or misleading information about the product’s safety, quality or effectiveness when they are assessing it, you commit a criminal offence. A conviction can result in a fine and, in some cases, imprisonment.

Any Person s.151 MHRA

If you are the holder of a marketing authorisation or a parallel import licence and you give information that is false or misleading about the safety, quality or efficacy of your medicinal product to the licensing authority, the EMA or other EEA authorities, you commit a criminal offence. The MHRA can prosecute you, and a conviction may result in a fine (potentially unlimited) and/or imprisonment, as set by the court.

Any Person s.96 MHRA

If you give the MHRA or the European Medicines Agency information that you are required to supply under the Human Medicines Regulations, and that information is false or misleading in any material way, you are committing a criminal offence. A conviction can lead to a fine, imprisonment, or both, depending on how the court decides the case.

Any Person s.208 MHRA

If your business holds a registration certificate for a medicinal product and you give the Medicines and Healthcare products Regulatory Agency (MHRA) any information about the product’s quality that is false or misleading, you commit a criminal offence. Conviction can lead to an unlimited fine and, in the most serious cases, imprisonment.

Any Person s.120 MHRA

If you place or broadcast an advert that is likely to lead someone to use a medicinal product for the purpose of inducing an abortion, you commit a criminal offence. A conviction can result in a fine and/or imprisonment, although the exact penalties are set elsewhere in the regulations. This applies to any business or individual that produces such advertising.

Any Person s.283 MHRA

If you place or circulate an advertisement for a medicine that implies the product is a food, cosmetic, or any other non‑medicinal consumer item, or that its safety or effectiveness comes simply because it is natural, you are committing an offence. This applies to any business or individual that markets medicinal products. Conviction can lead to prosecution by the MHRA and may attract fines and/or imprisonment, though the exact penalties are set elsewhere in the regulations.

Any Person s.288 MHRA

If you place an advertisement for a medicinal product that says a doctor’s visit, a surgical operation, or a medical consultation is unnecessary, or you offer a diagnosis or treatment advice by post or online, you are committing an offence. The same applies if the ad could cause people to mis‑diagnose themselves from a case‑history description. Conviction can result in fines and/or imprisonment, so advertising must be carefully reviewed for compliance.

Any Person s.286 MHRA

If you place an advertisement for a medicinal product in Great Britain, Northern Ireland or the whole UK without the required marketing authorisation, temporary authorisation, controlled‑opinion‑register entry or a therapeutic‑goods‑registration, you are committing a criminal offence. Breaching this prohibition can lead to a fine and/or imprisonment, depending on how the courts treat the offence.

Any Person s.279 MHRA

If your business sells or supplies a regulated medicine in packaging that does not meet the requirements of regulation 273 (unless an exemption applies), or you sell a medicine containing aspirin or paracetamol that is prohibited under regulation 275, you commit a criminal offence. On conviction you may face an unlimited fine and, if tried in the Crown Court, up to two years’ imprisonment, or both.

Any Person s.276 MHRA

If you run a retail pharmacy and sell or offer for sale a medicine that is not permitted for general sale, without doing so from a registered pharmacy under the supervision of a pharmacist (or in line with regulations 220A/220B), you commit a criminal offence. Conviction can result in a fine and, in the most serious cases, imprisonment.

Any Person s.220 MHRA

If you place medicines in a vending‑machine or other automatic dispenser and the product is not allowed for general sale, you are committing an offence. This applies to any business that offers medicines through unattended machines. Conviction can lead to a fine and, in more serious cases, imprisonment.

Any Person s.222 MHRA

If you sell a medicine that a customer specifically asks for by name – and that name appears at the head of a relevant monograph – you must ensure the product meets the standard set out in that monograph. Selling or supplying a product that does not meet that standard is a criminal offence. Conviction can lead to a fine and, in serious cases, imprisonment.

Any Person s.251 MHRA

If you sell, supply or even keep a medicinal product in Great Britain (but you are not the authorised marketing holder) and you know, or ought to have known, that the product’s packaging or information leaf‑let does not meet the legal requirements – or that a required leaf‑let is missing – you commit a criminal offence. Conviction can attract a fine and, in the more serious cases, imprisonment.

Any Person s.269 MHRA

If you hold a UK marketing authorisation, UKMA (GB) certificate, a registration or a traditional herbal registration for a medicinal product and you sell or supply that product in Northern Ireland, you must ensure the packaging and any package leaflet meet the requirements set out in the Human Medicines Regulations. Supplying a product whose packaging or leaflet does not meet those requirements, or supplying it without a required leaflet, is a criminal offence. Conviction can lead to a fine and, in some cases, imprisonment.

Any Person s.268 MHRA

If your business sells, supplies or even offers to sell a medicinal product in Northern Ireland, and you know (or have reasonable cause to believe) that the product’s packaging or the accompanying leaflet does not meet the legal requirements, you commit a criminal offence. The same applies if the product should have a leaflet but none is provided. Conviction can lead to a fine and/or imprisonment, depending on how the court decides the case.

Any Person Offences relating to packaging and package leaflet MHRA

You must not sell or offer for sale a medicinal product that is allowed for general sale unless you do it from premises you occupy and can close to the public, the product has been pre‑packed elsewhere and its outer packaging is still unopened, and, where required, you follow the presentation rules in Schedule 15. Breaching any of these conditions is a criminal offence and can lead to prosecution, a fine and/or up to two years’ imprisonment.

Any Person s.221 MHRA

It is a criminal offence to sell or supply a prescription‑only medicine unless you have a valid prescription from an appropriate practitioner. This applies to anyone who deals in medicines – pharmacies, online retailers, or any business that supplies such products. If you breach the rule you can be prosecuted and face a fine and/or imprisonment, although the exact penalties are set out elsewhere in the Regulations.

Any Person s.214 MHRA

If your business holds a UK marketing authorisation, a certificate of registration, a traditional herbal registration or an Article 126a authorisation, you must not sell prescription‑only or pharmacy medicines wholesale to anyone who is not listed in Schedule 22. The same rule applies to any company that manufactures or wholesales medicines. Breaching this rule can lead to criminal prosecution.

Any Person s.249 MHRA

If you give a patient an advanced therapy medicinal product (such as a gene‑therapy or cell‑based treatment) and you do not have a system that can link the product to the patient and vice‑versa, you commit a criminal offence. The same applies if the product contains human cells or tissues and your traceability system does not meet the extra requirements set out in the relevant Human Fertilisation, Blood Safety or Human Tissue regulations. Giving a written assurance that a traceability system exists when it does not is also an offence.

Any Person s.254 MHRA

If someone is convicted of an offence under regulation 255(8) and a court orders them not to use the pharmacy premises for up to two years, using those premises for a retail pharmacy business while the order is in force is a criminal offence. On summary conviction the person faces an unlimited fine (level 5 on the standard scale) and may also be ordered to pay costs.

Any Person s.256 MHRA

Record keeping 6

If you run a retail pharmacy, every time you sell or supply a prescription‑only medicine you must log the transaction in a written or electronic record the same day (or the next day if that’s not practicable). You also have to keep that record, the prescription and any related invoice or order for two years after the sale.

Trader/Business s.253 MHRA When you sell or supply a prescription‑only medicine (except health prescriptions, oral …

If your business holds a certificate of registration for a human medicine, you must retain any documents or information that would help you pull the product from sale or recall it if a safety issue arises. Keep those records organised and readily accessible for as long as you hold the registration.

Manufacturer/Importer s.117 MHRA When you hold a certificate of registration for a medicine

If your business holds a traditional herbal registration, you must retain any documents or information that would allow you to withdraw or recall that product from the market quickly. This means keeping up‑to‑date records of batches, distribution, composition and any other data needed to act if a safety issue arises.

Manufacturer/Importer s.147 MHRA Holder of a traditional herbal registration

If your company holds a marketing authorisation or a parallel import licence for a medicinal product, you must retain any documents or information that would help you pull that product from the market if needed. This means keeping things like batch records, distribution logs and recall plans readily available.

Any Person s.77 MHRA When you hold a marketing authorisation or a parallel import licence for …

If your company holds a UK marketing authorisation or traditional herbal registration, you must keep a detailed pharmacovigilance system master file that meets Part 11 of the regulations. Inspectors can check this file and tell you if you’re not meeting the rules; you must fix any problems and keep the file up‑to‑date.

Manufacturer/Importer s.331 MHRA when holding a UK marketing authorisation or traditional herbal registration

If you are the marketing‑authorisation holder for a medicine, you must keep a record of every suspected adverse reaction that is brought to your attention, whether reported by patients, health‑care professionals or arising from post‑authorisation studies. You cannot refuse reports received electronically or by any other appropriate method, and all records must be kept in one accessible place in the UK. Clinical‑trial reactions are excluded from this duty.

Manufacturer/Importer s.187 MHRA Whenever a suspected adverse reaction to the product is brought to the …

Registration and licensing 26

If you want to manufacture or wholesale human medicines you must apply to the licensing authority. Your application has to use the form and format set out in Schedule 3 and include all the information, documents, samples and product descriptions that Schedule 3 requires.

Manufacturer/Importer s.21 MHRA When seeking a manufacturer or wholesale dealer licence for medicinal products

If you want to act as a broker for medicines, you must apply to the licensing authority for a broker registration. They will decide within 90 days to grant or refuse the licence. Approved brokers will appear on a public register with their name, trading name and UK address; you must get a written reason if the application is refused.

Any Person Grant or refusal of broker’s registration MHRA When you wish to act as a broker or apply for registration

If you want to sell or supply a medicinal product in Northern Ireland that doesn’t already have a UK licence, you must obtain an Article 126a authorisation. This requires you to prove the product is authorised in an EU state, that you’re established in the EU, that it will be imported from that EU state, and that supplying it in NI is justified for public‑health reasons. Without the authorisation you can’t legally supply the product in Northern Ireland.

Trader/Business s.156 MHRA When you want to sell or supply a medicinal product in Northern …

If you sell a traditional herbal product that has been used for fewer than 15 years, you must apply for a THR(GB). The Medicines regulator will review your application and, if condition D is not met but all other conditions are satisfied, will refer the matter to a committee. You may need to provide a herbal monograph or other evidence to satisfy the regulator before your product can be marketed.

Any Person Procedure where less than 15 years use of traditio MHRA You have a traditional herbal medicinal product that has been used for …

You must send a written (or electronic) application, signed and with the required fee, to the licensing authority before the start of the nine‑month period that ends when your current certificate expires. The application must include a consolidated file on the product’s quality, safety and efficacy, and you must be established in the correct part of the UK or EU for the type of certificate you hold. The authority will only renew the certificate if it is satisfied the product’s benefits outweigh any health risks.

Manufacturer/Importer s.108 MHRA When your certificate of registration is within nine months of its expiry …

If you hold a UK marketing authorisation for a medicine that shares its active ingredient with other products, you can request the EMA or the UK licensing authority to align the periodic safety update report (PSUR) dates or frequency. Once the change is announced, you must apply to amend your product’s authorisation to reflect the new PSUR schedule within six months.

Manufacturer/Importer s.193 MHRA You hold a UK marketing authorisation for a medicine that shares the …

When you hold a certificate of registration for a human medicine you must make sure it clearly states whether the product can only be sold from a pharmacy or can be sold on general sale. You can only ask for a general‑sale term if the licensing authority is convinced the product is safe to sell without a pharmacist’s supervision.

Manufacturer/Importer s.106 MHRA When applying for or holding a certificate of registration for a human …

If your company is applying for a UK marketing authorisation for a medicine that treats serious or life‑threatening conditions, or is needed in an emergency public‑health situation, and you do not yet have full clinical data, you can ask for a conditional authorisation. You must include clear evidence in the application that the product’s benefits outweigh the risks, that you will supply the missing data soon, that it meets an unmet medical need, and that the public‑health benefit justifies the early launch.

Manufacturer/Importer Applications relating to conditional marketing aut MHRA When applying for a UK marketing authorisation for a medicine aimed at …

If your company wants to be registered as an importer, manufacturer or distributor of medicinal active substances, you must submit a detailed application to the MHRA. The application must include your business and contact details, all premises used, qualifications of key staff, information on the substances (CAS numbers, quantities, codes), and how you will store, test and control quality. This information is required before any registration can be granted.

Manufacturer/Importer Schedule 7A MHRA When applying for registration as an active‑substance importer, manufacturer or distributor

If you are applying for a UK marketing authorisation for a medicine that contains a new combination of active substances, you must include the results of any new pre‑clinical tests or clinical trials that relate to that combination. You do not have to supply separate scientific references for each individual substance.

Manufacturer/Importer s.55 MHRA When submitting a UK marketing authorisation application for a product with a …

If your business holds a licence to manufacture or assemble medicines and you need a certificate (for your own use, to export, or for a foreign regulator), you must give the licensing authority the relevant UK marketing authorisation, Article 126a authorisation, registration certificate or traditional herbal registration, or explain why none is available. Supplying this information allows the authority to issue the certificate you need.

Manufacturer/Importer s.31 MHRA When you request a certificate for your manufacturing licence (e.g., for export …

If your company applies for a UK marketing authorisation (UKMA(NI)) for a medicinal product that references another product and meets any of the circumstances set out in Article 10(3) of the 2001 Directive, you must include the specific information called for in Articles 10(3) and 10(6). This information forms part of the application and must be supplied before the authority can consider the authorisation.

Manufacturer/Importer s.52 MHRA When you submit a UKMA(NI) for a medicinal product that references another …

If you are applying for a UK marketing authorisation for a biological medicine and you cannot prove it is a generic version under the rules in Article 10(4) of the 2001 Directive, you must submit additional data and documents as set out in Articles 10(4) and 10(6). The same reporting rules that apply to generic applications (Regulation 51 (2)) also apply to your submission.

Manufacturer/Importer s.53 MHRA When your biological product cannot be demonstrated to meet the generic condition …

If your business supplies (brokers) medicines in Great Britain or Northern Ireland, you must be formally registered as a broker, have a UK permanent address on the register, only deal with medicines that have a valid authorisation, and follow the good distribution practice guidelines. Without meeting all these conditions you cannot legally broker medicinal products.

Trader/Business Brokering in medicinal products MHRA When you act as a broker of medicinal products in Great Britain …

When you apply for a traditional herbal registration you must state whether the product will only be sold from a pharmacy or can be sold generally. You may only choose "general sale" if the licensing authority has confirmed that the product can be safely sold without a pharmacist’s supervision.

Manufacturer/Importer s.131 MHRA When applying for a traditional herbal registration under the Human Medicines Regulations …

If you want to manufacture or assemble medicines in the UK, you must apply for a manufacturer’s licence and provide detailed information about your business, premises, qualified staff and the processes you will use. The application must also include details of storage, animal or tissue use and, for advanced (MM) or point‑of‑care (POC) products, a supporting dossier with specific modular‑unit information. This ensures the regulator knows who is responsible for quality, supervision and safety before you start production.

Manufacturer/Importer Schedule 3 MHRA When you intend to manufacture or assemble medicinal products (including MM or …

If you hold an active‑substance registration and need to change any part of it, you must send a written, signed request to the licensing authority. The request must clearly state the change you want, include any supporting information the authority asks for, and be accompanied by the correct fee.

Manufacturer/Importer Variation of an active substance registration on a MHRA When you wish to vary an existing active‑substance registration

If you want to act as a broker for medicinal products you must apply to the licensing authority. The application has to include your name, trading name (if any), UK address, contact details, the type and range of medicines you intend to broker, proof you can meet the relevant regulations and the required fee. It must be in English, signed, pages numbered and include extra address/contact information if records are kept elsewhere or if someone else files the form for you.

Trader/Business Application for brokering registration MHRA When you seek registration as a broker of medicinal products

If you are a medicines broker and need to change any detail of your registration, you must send a written application to the licensing authority. The application must name the change you want, be signed, include any required supporting information and the appropriate fee. The authority must decide within 30 days unless it asks you for more information, which pauses the clock.

Any Person Variation of a broker’s registration on the applic MHRA When you wish to change the details of your broker registration

If your business is listed under the Human Medicines Regulations and you need to change the details on that list, you must put a written application to the licensing authority. The application must clearly state the change you want, be signed, and include any information the authority asks for.

Any Person Variation of a person’s entry on the list on the a MHRA When you want to vary the entry of your person on the …

If you want to market a traditional herbal medicine in the UK, you must provide a detailed set of documents with your registration application, covering things like product name, ingredients, manufacturing method, safety data, environmental impact and labelling. Your business must gather all this information and submit it as part of the application.

Manufacturer/Importer Schedule 12 MHRA When applying for a traditional herbal registration in the UK

If your business holds a Traditional Herbal Registration (THR), you must send a written, signed (or e‑signed) application to the licensing authority before the renewal deadline. The application must include any required fee and a full dossier of quality, safety and efficacy data, adverse‑reaction evaluations and any variations since the original registration. It must be received before the nine‑month period that ends on the expiry date of the current registration.

Manufacturer/Importer s.133 MHRA when your traditional herbal registration is approaching expiry (within the nine‑month period …

If your business holds a UK marketing authorisation for a medicine, you must apply to renew it before it expires. The renewal must be a written (or e‑signed) application with any required fee, and you must supply a consolidated dossier of quality, safety and efficacy data, including adverse‑reaction reports and any amendments made since the original authorisation.

Manufacturer/Importer s.66 MHRA When a UK marketing authorisation is approaching expiry (within the 9‑month renewal …

When you apply for a parallel import licence for a medicinal product, you must provide the regulator with a set list of details – the applicant’s name and address, product name, product specifications, UK reference product, and, if asked, environmental risk assessments, pharmacovigilance details, risk‑management plans, product characteristics, and mock‑ups of packaging and leaflets. All the required material has to accompany the licence application.

Trader/Business Schedule 8A MHRA When submitting an application for a parallel import licence under Regulation 50(1A)

If an EU urgent action is started for your medicine and the resulting agreement says the product details must change, you must apply to the licensing authority to vary your authorisation. The application must contain a refreshed summary of the product characteristics and an updated patient leaf‑let, and it must be lodged within the timetable set out in the agreement.

Manufacturer/Importer s.197 MHRA EU urgent action procedure is initiated and an agreement under Article 107k …

If a safety update report for your UK‑authorised medicine is assessed under the EU single‑assessment procedure and the outcome requires a change to your authorisation, you must apply to the licensing authority for that variation. Your application must include an updated summary of product characteristics and a new package leaflet, and it must be submitted by the deadline set out in the agreement.

Manufacturer/Importer s.194 MHRA When an EU single‑assessment agreement (Article 107g(2)) requires a variation to your …

Reporting and filing 27

If you are applying for a UK marketing authorisation for a medicine that includes a paediatric use, or you are adding a paediatric indication to an existing authorisation, you must attach a plan that explains how you will monitor its effectiveness and any side‑effects in children. This information has to be part of the application you submit to the regulator.

Manufacturer/Importer Other applications including paediatric indication MHRA When making a UKMA (Category 1) application that includes a paediatric indication, …

If the Medicines regulator sends you a written notice asking for a copy of an advertisement you have published or plan to publish for a medicinal product, you must send that copy to the regulator within the time they set. The notice can also stop you from publishing the ad.

Any Person s.304 MHRA When you receive a notice under this regulation requiring you to supply …

When you apply for a UK marketing authorisation for an advanced therapy medicinal product, you must give the regulator details of how you will monitor the product’s effectiveness and any side‑effects. If the product also includes a medical device, you must also supply proof that it meets the Medical Devices Regulations, including any notified‑body assessment report.

Manufacturer/Importer Applications relating to advanced therapy medicina MHRA When applying for a UK marketing authorisation (Category 1) for an advanced …

If your company is applying for a UK marketing authorisation for a point‑of‑care (POC) medicine, you must include details of how you will monitor the product’s effectiveness and any adverse reactions after it is on the market. This information goes to the licensing authority (MHRA) as part of your application.

Manufacturer/Importer Applications relating to POC medicinal products MHRA When submitting a UK marketing authorisation application for a POC medicinal product

If the MHRA (or other UK licensing authority) asks you for more details or an oral/written explanation about your marketing authorisation application, you must supply that information. Your response allows the authority’s decision clock to continue, so any delay on your part can hold up the approval process.

Manufacturer/Importer s.58 MHRA When the licensing authority requests further information or an oral/written explanation about …

If the Medicines and Healthcare products Regulatory Agency (MHRA) decides to carry out a major safety review of a medicine you hold a UK marketing authorisation for, they will notify you. You must supply any information they request, within the time they set, and you can mark any data that is a trade secret or otherwise confidential.

Manufacturer/Importer Major safety review by the licensing authority MHRA When the licensing authority (MHRA) notifies you that your authorised medicine is …

If you apply to be listed as a person who can supply medicinal products at a distance and the licensing authority asks for more information, you must supply that information within the deadline they set. The time they give you to provide the information does not count towards the authority’s 90‑day decision period.

Trader/Business Procedure for listing persons who may supply medic MHRA When the licensing authority issues a request for information after you submit …

If your company holds a UK marketing authorisation for a medicinal product, you must give the holder of the product’s manufacturing licence the details they need to keep their licence and master file in line with that authorisation. In practice you need to share up‑to‑date manufacturing and control information whenever it changes.

Trader/Business Obligation to provide information relating to meth MHRA When you hold a UK marketing authorisation for an MM medicinal product

If you hold a traditional herbal medicine registration, you must promptly tell the licensing authority about any new data that could affect the product’s safety, efficacy, or use. This includes foreign restrictions, trial results, off‑label use or any other relevant information, and you must apply to vary the registration if the information requires a change.

Manufacturer/Importer s.145 MHRA When you become aware of new safety, efficacy, usage or regulatory information …

If the Medicines Licensing Authority asks you for more information about your broker registration application, you must supply that information within the timeframe set by the authority. The clock starts when you receive the notice and stops when the authority gets the information or you demonstrate you cannot provide it.

Trader/Business Procedure for determining an application for broke MHRA When the licensing authority issues a notice requesting additional information for your …

If a licensing authority or the Ministers ask you for information, documents or assistance under the Human Medicines Regulations and they do not give a deadline in the original rule, they will send you a written notice saying when it must be done. You must supply what they ask for by that deadline.

Any Person s.342 MHRA When you receive a written notice from the licensing authority or Ministers …

If your company holds a UK marketing authorisation for a medicine or a parallel‑import licence, you must tell the MHRA about any new safety, efficacy or usage data that could affect the licence. You also have to supply any information the MHRA specifically requests, and apply to vary the licence if the new data requires it.

Manufacturer/Importer s.75 MHRA When you become aware of new information that could affect the marketing …

If you hold a certificate of registration for a medicine, you must tell the licensing authority as soon as you learn of any new information that could affect the product’s safety, effectiveness or regulatory status. This includes restrictions in other countries, trial results, off‑label use and any other data that might change the balance of benefits and risks. If the information means the certificate needs to be changed, you must apply to vary it promptly.

Manufacturer/Importer s.115 MHRA When you become aware of new information that could affect the safety, …

If the MHRA (or another minister) sends you a notice telling you to stop an advertisement and to publish a corrective statement, you must do so within the time and in the format the notice specifies. This means putting the minister’s reasons and your correction on the same medium where the original ad appeared (e.g., website, newspaper).

Trader/Business s.307 MHRA Receipt of a regulatory notice requiring a corrective statement about an advertisement

If a court issues a permanent injunction against your business for a medicine advertisement, you must publish the court’s decision (or part of it) and a corrective statement about the ad. The Minister will tell you how and when to do this, and you must follow those instructions.

Any Person s.313 MHRA A court grants a non‑interim injunction under regulation 311 for an advertisement …

If you operate as a broker of medicinal products, you must tell the licensing authority (and the relevant marketing authorisation holder) straight away if you think a product is falsified. You also need to submit an annual report showing you have a system to comply with medicine regulations, update the authority if anything changes, and pay any required fee.

Trader/Business Provision of information MHRA When you identify, suspect, or have reasonable grounds to believe a medicinal …

If your business is on the licensing authority’s list, you must tell the authority straight away if you find, suspect or have reasonable grounds to think any medicinal product is falsified, and you must also inform them of any material change to your situation. You also have to reply to any formal request from the authority for further information within the time‑frame it sets.

Any Person Provision of information to the licensing authorit MHRA Being a person entered on the licensing authority’s list and identifying, knowing, …

If the MHRA (the licensing authority) tells you it wants to suspend, change or cancel your medicine licence, you must act. You have to send written comments within the time limit or tell them you want an oral hearing (and pay the relevant fee). Your response must be received before the proposed effective date, which is at least 28 days after the authority’s notice.

Trader/Business s.27 MHRA When you receive a written proposal from the licensing authority to suspend, …

If you’re applying for a marketing authorisation for a combined advanced therapy medicinal product (ATMP), you must provide the licensing authority (MHRA) with the assessment report from a notified body, or any other information the authority asks for. The authority will rely on this information when it looks at your application.

Any Person Consideration of applications relating to combined MHRA When submitting an application under regulation 50H(3) for a combined ATMP

When you apply for a UK marketing authorisation (or related authorisation) for a medicinal product, you must give the regulator a prototype of the product’s outer and immediate packaging together with a draft patient information leaflet. You also need to supply any patient‑group testing results on the packaging and leaflet. If you later want to change the packaging or leaflet (apart from changes linked to the product’s official description), you must again send the revised mock‑ups and leaflet, and you can only make the change after 90 days if the authority does not object.

Manufacturer/Importer s.267 MHRA When applying for a UK marketing authorisation, Article 126a authorisation, certificate of …

If your business holds a parallel import licence for a medicine, you must give the licensing authority (e.g., MHRA) periodic safety update reports (PSURs) whenever they ask. The report must include benefit‑risk data, a scientific evaluation, and sales/prescription volume information, and it must be sent electronically by the deadline they set.

Trader/Business Obligation on holder of a parallel import licence MHRA When notified by the licensing authority that a PSUR is required

If you own a UK marketing authorisation for a medicinal product, the licence will set a timing requirement for safety reports. You must prepare and send a periodic safety update report (PSUR) to the MHRA each time the licence says you should – usually yearly. Missing a report can lead to fines or other sanctions.

Trader/Business s.63 MHRA when you hold a UK marketing authorisation for a medicinal product regulated …

If your company holds a UK marketing authorisation for a medicine – whether it is a generic, a product with a well‑established use or a traditional herbal registration – you must regularly send a Periodic Safety Update Report (PSUR) to the EMA and/or the UK licensing authority. The report must include benefit‑risk summaries, a scientific risk‑benefit evaluation, and sales/prescribing data, and it must be filed electronically on the timetable set out in the authorisation (or the default schedule in the regulation).

Manufacturer/Importer s.191 MHRA If your business holds a UK marketing authorisation (or Article 126a authorisation) …

If a pharmacovigilance review leads to an agreement that your medicine’s licence needs to be changed, you must apply to the licensing authority for a variation. The application must include an updated summary of the product’s characteristics and a new package leaflet, and it must be submitted according to the timetable set out in the agreement.

Manufacturer/Importer s.202 MHRA When an agreement reached after a pharmacovigilance recommendation requires a variation to …

If your company applies for a UK marketing authorisation, you must keep the information you originally supplied up to date. Add any new data that could affect the safety, quality or efficacy assessment and send the updates to the regulator as soon as you become aware of them.

Manufacturer/Importer s.57 MHRA When you are the applicant for a UK marketing authorisation

If your company applies for a parallel import licence, you must keep the information you supplied with the application up‑to‑date. As soon as you learn of any new safety, quality or efficacy data for the product, you need to send that information to the regulator and do so as soon as reasonably practicable.

Trader/Business Obligation to update information supplied in conne MHRA When you become aware of new safety, quality or efficacy information about …

If you apply for a traditional herbal medicine registration, you must tell the regulator about any new information that could affect the product’s safety, quality or effectiveness as soon as you become aware of it. This keeps your registration up‑to‑date and ensures the product remains compliant.

Manufacturer/Importer s.129 MHRA When you become aware of new safety, quality or efficacy information relevant …

Penalties for non-compliance

74 penalties under this legislation. 71 can result in imprisonment. 73 carry an unlimited fine.

Prison risk

Appoint and maintain a responsible person (import) for medicine imports

Unlimited fine and/or 2 years imprisonment

Either way Requirement as to responsible persons where licenc Penalises: Appoint and maintain a responsible person (import) for …

Prison risk

Comply with GMP and maintain required records, notifications and testing for medicinal product manufacturing

Unlimited fine and/or 2 years imprisonment

Either way Schedule 4 Penalises: Comply with GMP and maintain required records, notifications …

Prison risk

Comply with GMP/GDP and obtain export confirmations for active substances

Unlimited fine and/or 2 years imprisonment

Either way Requirements for registration as an importer, manu Penalises: Comply with GMP/GDP and obtain export confirmations for …

Prison risk

Ensure correct labelling of radionuclide medicines

Unlimited fine and/or 2 years imprisonment

Either way s.262 Penalises: Ensure correct labelling of radionuclide medicines

Prison risk

Ensure homeopathic ads meet registration conditions

Unlimited fine and/or 2 years imprisonment

Either way s.301 Penalises: Ensure homeopathic ads meet registration conditions

Prison risk

Ensure medicinal product packaging displays required information

Unlimited fine and/or 2 years imprisonment

Either way s.257 Penalises: Ensure medicinal product packaging displays required information

Prison risk

Ensure required labeling on POC medicinal product packaging

Unlimited fine and/or 2 years imprisonment

Either way Packaging requirements: POC medicinal products Penalises: Ensure required labeling on POC medicinal product packaging

Prison risk

Fail to meet medicinal product authorisation requirements

Unlimited fine and/or 2 years imprisonment

Either way s.47 Penalises: Keep product information up to date with current …

Prison risk

Label homoeopathic medicines as required by law

Unlimited fine and/or 2 years imprisonment

Either way Schedule 28 Penalises: Label homoeopathic medicines as required by law

Prison risk

Maintain quality‑assuring facilities and notify the regulator of changes

Unlimited fine and/or 2 years imprisonment

Either way s.39 Penalises: Maintain quality‑assuring facilities and notify the regulator of …

Prison risk

Only manufacture POC medicines with licence and master file

Unlimited fine and/or 2 years imprisonment

Either way Manufacturing of POC medicinal products Penalises: Only manufacture POC medicines with licence and master …

Prison risk

Only manufacture under a licence and master file

Unlimited fine and/or 2 years imprisonment

Either way Manufacturing of MM medicinal products Penalises: Only manufacture under a licence and master file

Prison risk

Provide Braille label and accessible leaflets for medicines

Unlimited fine and/or 2 years imprisonment

Either way s.259 Penalises: Provide Braille label and accessible leaflets for medicines

Prison risk

Provide packaging & leaflets in English (or obtain exemption)

Unlimited fine and/or 2 years imprisonment

Either way s.266 Penalises: Provide packaging & leaflets in English (or obtain …

Prison risk

Sell or supply product breaching a borderline notice

Unlimited fine and/or 2 years imprisonment

Either way s.166 Penalises: Comply with notice to stop selling an unauthorised …

Prison risk

Do not sell or facilitate sale of suspended traditional herbal medicines

Unlimited fine and/or 2 years imprisonment

Either way s.141 Penalises: Do not sell or facilitate sale of suspended …

Prison risk

Do not sell or supply suspended medicines

Unlimited fine and/or 2 years imprisonment

Either way s.72 Penalises: Do not sell or supply suspended medicines

Prison risk

Apply false warranty or certificate to a medicine

Unlimited fine and/or 2 years imprisonment

Either way s.337 Penalises: Apply false warranty or certificate to a medicine

Prison risk

Breach any provision of the Human Medicines Regulations

Unlimited fine and/or 2 years imprisonment

Either way s.152 Penalises: Breach any provision of the Human Medicines Regulations

Prison risk

Breach any provision of the Human Medicines Regulations

Unlimited fine and/or 2 years imprisonment

Either way s.98 Penalises: Breach any provision of the Human Medicines Regulations

Prison risk

Breach Commission Regulation 2016/161

Unlimited fine and/or 2 years imprisonment

Either way Offences relating to Commission Regulation 2016/16 Penalises: Breach Commission Regulation 2016/161

Prison risk

Breach of medicines regulations or give false information

Unlimited fine and/or 2 years imprisonment

Either way Offences: breach of regulations and false informat Penalises: Breach of medicines regulations or give false information

Prison risk

Breach of regulation 45K requirements for human medicines

Unlimited fine and/or 2 years imprisonment

Either way Penalties Penalises: Breach of regulation 45K requirements for human medicines

Prison risk

Breach regulation 175 exceptions for human medicines

Unlimited fine and/or 2 years imprisonment

Either way s.176 Penalises: Breach regulation 175 exceptions for human medicines

Prison risk

Cease supply of authorised medicine without proper transfer or EMA notice

Unlimited fine and/or 2 years imprisonment

Either way s.89 Penalises: Cease supply of authorised medicine without proper transfer …

Prison risk

Employer liable for employee's application offence

Unlimited fine and/or 2 years imprisonment

Either way s.123 Penalises: Employer liable for employee's application offence

Prison risk

Employer liable for employee's medicines application offence

Unlimited fine and/or 2 years imprisonment

Either way s.154 Penalises: Employer liable for employee's medicines application offence

Prison risk

Employer liable for employee's medicines offence

Unlimited fine and/or 2 years imprisonment

Either way s.211 Penalises: Employer liable for employee's medicines offence

Prison risk

Fail to comply with any requirement of the Human Medicines Regulations

Unlimited fine and/or 2 years imprisonment

Either way s.207 Penalises: Fail to comply with any requirement of the …

Prison risk

Fail to comply with MHRA compliance notice

Unlimited fine and/or 2 years imprisonment

Either way s.270 Penalises: Fail to comply with MHRA compliance notice

Prison risk

Fail to comply with MHRA notice or corrective requirement

Unlimited fine and/or 2 years imprisonment

Either way s.308 Penalises: Fail to comply with MHRA notice or corrective …

Prison risk

Fail to comply with pharmacovigilance conditions

Unlimited fine and/or 2 years imprisonment

Either way s.97 Penalises: Fail to comply with pharmacovigilance conditions

Prison risk

Fail to comply with urgent safety restriction duties

Unlimited fine and/or 2 years imprisonment

Either way s.80 Penalises: Fail to comply with urgent safety restriction duties

Prison risk

Fail to comply with urgent safety restriction duties for traditional herbal registrations

Unlimited fine and/or 2 years imprisonment

Either way s.149 Penalises: Fail to comply with urgent safety restriction duties …

Prison risk

Fail to comply with urgent safety restrictions on parallel import licence

Unlimited fine and/or 2 years imprisonment

Either way Urgent safety restrictions: parallel import licenc Penalises: Fail to comply with urgent safety restrictions on …

Prison risk

Fail to give accurate information in parallel import licence application

Unlimited fine and/or 2 years imprisonment

Either way Offences in connection with parallel import licenc Penalises: Fail to give accurate information in parallel import …

Prison risk

Fail to give correct information on homoeopathic medicine registration

Unlimited fine and/or 2 years imprisonment

Either way s.119 Penalises: Fail to give correct information on homoeopathic medicine …

Prison risk

Employer liable for employee's breach of regulation 95

Unlimited fine and/or 2 years imprisonment

Either way s.100 Penalises: Fail to give truthful information in a marketing …

Prison risk

Fail to give truthful information in a marketing authorisation application

Unlimited fine and/or 2 years imprisonment

Either way s.95 Penalises: Fail to give truthful information in a marketing …

Prison risk

Fail to keep or transfer ATMP data as required

Unlimited fine and/or 2 years imprisonment

Either way s.33 Penalises: Fail to keep or transfer ATMP data as …

Prison risk

Fail to maintain required risk management or traceability system for medicines

Unlimited fine and/or 6 months imprisonment

Either way s.87 Penalises: Fail to maintain required risk management or traceability …

Prison risk

Fail to meet pharmacovigilance obligations

Unlimited fine and/or 2 years imprisonment

Either way Offences in relation to pharmacovigilance obligati Penalises: Fail to meet pharmacovigilance obligations

Prison risk

Fail to meet pharmacovigilance reporting obligations

Unlimited fine and/or 2 years imprisonment

Either way s.210 Penalises: Fail to meet pharmacovigilance reporting obligations

Prison risk

Fail to notify paediatric study results

Unlimited fine and/or 2 years imprisonment

Either way s.93 Penalises: Fail to notify paediatric study results

Prison risk

Fail to place product on market with paediatric indication

Unlimited fine and/or 2 years imprisonment

Either way s.90 Penalises: Fail to place product on market with paediatric …

Prison risk

Fail to provide accurate information for herbal medicine registration

Unlimited fine and/or 2 years imprisonment

Either way s.150 Penalises: Fail to provide accurate information for herbal medicine …

Prison risk

Fail to provide compliant packaging or leaflets for medicines in NI

Unlimited fine and/or 2 years imprisonment

Either way Offence relating to packaging and package leaflets Penalises: Fail to provide compliant packaging or leaflets for …

Prison risk

Illegally sell or supply prescription medicines

Unlimited fine and/or 2 years imprisonment

Either way s.255 Penalises: Illegally sell or supply prescription medicines

Prison risk

Provide false information or fail record‑keeping for special‑patient medicines

Unlimited fine and/or 2 years imprisonment

Either way s.175 Penalises: Provide false information or fail record‑keeping for special‑patient …

Prison risk

Provide false or misleading information in herbal registration

Unlimited fine and/or 2 years imprisonment

Either way s.151 Penalises: Provide false or misleading information in herbal registration

Prison risk

Provide false or misleading information to regulators

Unlimited fine and/or 2 years imprisonment

Either way s.96 Penalises: Provide false or misleading information to regulators

Prison risk

Provide false or misleading information to the licensing authority

Unlimited fine and/or 2 years imprisonment

Either way s.208 Penalises: Provide false or misleading information to the licensing …

Prison risk

Provide false or misleading information to the MHRA

Unlimited fine and/or 2 years imprisonment

Either way s.120 Penalises: Provide false or misleading information to the MHRA

Prison risk

Publish advertisement likely to promote abortion medication

Unlimited fine and/or 2 years imprisonment

Either way s.283 Penalises: Publish advertisement likely to promote abortion medication

Prison risk

Publish misleading advertisement for a medicinal product

Unlimited fine and/or 2 years imprisonment

Either way s.288 Penalises: Publish misleading advertisement for a medicinal product

Prison risk

Publish prohibited medicinal product advertisement

Unlimited fine and/or 2 years imprisonment

Either way s.286 Penalises: Publish prohibited medicinal product advertisement

Prison risk

Publish unauthorised medicinal product advertisement

Unlimited fine and/or 2 years imprisonment

Either way s.279 Penalises: Publish unauthorised medicinal product advertisement

Prison risk

Sell medicinal product in improper container or prohibited aspirin/paracetamol

Unlimited fine and/or 2 years imprisonment

Either way s.276 Penalises: Sell medicinal product in improper container or prohibited …

Prison risk

Sell medicinal product not authorised for general sale

Unlimited fine and/or 2 years imprisonment

Either way s.220 Penalises: Sell medicinal product not authorised for general sale

Prison risk

Sell medicinal products from automatic machines without authorisation

Unlimited fine and/or 2 years imprisonment

Either way s.222 Penalises: Sell medicinal products from automatic machines without authorisation

Prison risk

Sell medicinal product that fails to meet monograph standard

Unlimited fine and/or 2 years imprisonment

Either way s.251 Penalises: Sell medicinal product that fails to meet monograph …

Prison risk

Sell medicinal product with non‑compliant packaging or leaf‑let

Unlimited fine and/or 2 years imprisonment

Either way s.269 Penalises: Sell medicinal product with non‑compliant packaging or leaf‑let

Prison risk

Sell medicinal product with non‑compliant packaging or leaflet

Unlimited fine and/or 2 years imprisonment

Either way s.268 Penalises: Sell medicinal product with non‑compliant packaging or leaflet

Prison risk

Sell medicinal product with non‑compliant packaging or leaflet in NI

Unlimited fine and/or 2 years imprisonment

Either way Offences relating to packaging and package leaflet Penalises: Sell medicinal product with non‑compliant packaging or leaflet …

Prison risk

Sell or supply general‑sale medicinal product outside a registered pharmacy

Unlimited fine and/or 2 years imprisonment

Either way s.221 Penalises: Sell or supply general‑sale medicinal product outside a …

Prison risk

Sell prescription‑only medicines without a prescription

Unlimited fine and/or 2 years imprisonment

Either way s.214 Penalises: Sell prescription‑only medicines without a prescription

Prison risk

Sell prescription or pharmacy medicine wholesale to unauthorised persons

Unlimited fine and/or 2 years imprisonment

Either way s.249 Penalises: Sell prescription or pharmacy medicine wholesale to unauthorised …

Prison risk

Treat patient with advanced therapy product without traceability

Unlimited fine and/or 2 years imprisonment

Either way s.254 Penalises: Treat patient with advanced therapy product without traceability

Prison risk

Record all suspected adverse reactions to your medicines

Unlimited fine and/or 2 years imprisonment

Either way s.187 Penalises: Record all suspected adverse reactions to your medicines

Prison risk

Report suspected falsified medicines to the licensing authority

Unlimited fine and/or 2 years imprisonment

Either way Provision of information to the licensing authorit Penalises: Report suspected falsified medicines to the licensing authority

Prison risk

Submit periodic safety update reports (PSURs) at the licence‑specified interval

Unlimited fine and/or 2 years imprisonment

Either way s.63 Penalises: Submit periodic safety update reports (PSURs) at the …

Unlimited fine

Fail to submit required EMA information for marketing authorisations

Unlimited fine

Either way s.79 Penalises: Fail to submit required EMA information for marketing …

Unlimited fine

Use pharmacy premises while disqualified

Unlimited fine

Summary only s.256 Penalises: Use pharmacy premises while disqualified

Fine

Obstruct inspector or refuse to comply/assist

Fine up to £1,000

Summary only s.334 Penalises: Obstruct inspector or refuse to comply/assist

Practical guidance

Our guides explain how to comply with the requirements above.

Sections and provisions

461 classified provisions from this legislation.

162 Duties 65 Offences and penalties 37 Powers 39 Definitions 97 Exemptions

Duties 162

Schedule 3 Applications for licences under Part 3
Schedule 4 Standard provisions of licences under Part 3 The licence holder
s.11 British Pharmacopoeia Commission
Schedule 12 Material to accompany an application for a traditional herbal registration precautionary and safety measures
s.14 Appointment of expert advisory groups
Schedule 15 Requirements for specific products subject to general sale
s.21 Application for manufacturer's or wholesale dealer's licence
s.22 Factors relevant to determination of application for manufacturer's or wholesale dealer's licence
s.27 Procedure where licensing authority proposes to suspend, revoke or vary licence The licensing authority
Schedule 28 Labelling requirements for registrable homoeopathic medicinal products
Schedule 29 Labelling of traditional herbal medicinal products
s.31 Certification of manufacturer's licence product
s.37 Manufacturing and assembly The licence holder
s.38 Imports from states other than EEA States / countries other than approved countries for import The licence holder
s.39 Further requirements for manufacturer's licence The licence holder
s.41 Requirements as to qualified persons person
s.43 Obligations of licence holder The licence holder
s.45 Requirement as to responsible persons change
s.51 Application for UKMA(NI) relating to generic medicinal products
s.52 Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc
... and 142 more duties

Offences and penalties 65

s.33 Offence concerning data for advanced therapy medicinal products
s.35 Penalties
s.47 Breach of requirement
s.79 Failure to provide information on marketing authorisations to EMA
s.80 Urgent safety restrictions
s.87 Offences in connection with risk management systems and traceability systems
s.89 Offences in connection with withdrawal of product from the market
s.90 Failure to place on the market taking account of paediatric indication
s.93 Failure to notify results of paediatric study
s.95 Offences in connection with application
s.96 Provision of false or misleading information
s.97 Breach of pharmacovigilance condition
s.98 General offence of breach of provision of this Part
s.99 Penalties
s.100 Persons liable
s.119 Offences in connection with applications
s.120 Provision of false or misleading information
s.121 General offence of breach of provision of this Part
s.122 Penalties
s.123 Persons liable
... and 45 more offences and penalties

Powers 37

s.23 Grant or refusal of licence
s.24 Standard provisions of licences
s.26 General power to suspend, revoke or vary licences
s.30 Provision of information
s.40 Obligation to provide information relating to control methods
s.59 Conditions of UK marketing authorisation or parallel import licence : general
s.61 Conditions of UK marketing authorisation: new obligations post-authorisation
s.71 Withdrawal of medicinal product from the market
s.102 Application of Part
s.110 Revocation, variation and suspension of certificate of registration
s.112 Withdrawal of homoeopathic medicinal product from the market
s.181 Delegation of obligations under this Part
s.198 Post-authorisation safety studies: general provisions
s.305 Invitation to make representations about compatibility
s.310 Complaints to Ministers: power to refer
s.311 Application for injunction
s.312 Application for injunction: accuracy of factual claim
s.316 Civil proceedings
s.323 Enforcement in England, Wales and Scotland
s.325 Rights of entry
... and 17 more powers

Definitions 39

Schedule 1 Further provisions for classification of medicinal products cyanogenic substances
s.5 Classification of medicinal products authorisation
s.7 Advertisements relating to medicinal products person qualified to prescribe or supply medicinal products
s.9 Commission on Human Medicines
Schedule 10 National homoeopathic products national homoeopathic product scientific data food
s.48 Application of this Part excluded reference product parallel import licence relevant medicinal product
s.49 Application for grant of UK marketing authorisation or parallel import licence
s.103 Application for certificate of registration
s.125 Traditional herbal medicinal products
s.127 Application for grant of traditional herbal registration
s.159 Provisional determination
s.165 Determination in other cases
s.167 Supply to fulfil special patient needs publish
s.168 Use of non-prescription medicines in the course of a business publish
s.171 Exempt advanced therapy medicinal products publish
s.177 Application of this Part and interpretation product co-ordination group Eudravigilance database
s.190 Signal detection: holder obligation relevant changes
s.195 Obligation on licensing authority to assess PSURs ... EU reference date EU single assessment procedure
s.206 Infringement notices relevant provision
s.213 Interpretation approved country health professional the Common Services Agency the dental care professionals register
... and 19 more definitions

Exemptions 97

Schedule 2 Supplementary provision relating to advisory bodies and expert advisory groups
s.6 The licensing authority and the Ministers
Schedule 8 Material to accompany an application for a UK marketing authorisation
s.17 Manufacturing of medicinal products
s.18 Wholesale dealing in medicinal products
s.19 Exemptions from requirement for wholesale dealer's licence
s.20 Mixing of medicines
s.36 Conditions for manufacturer's licence
s.42 Conditions for wholesale dealer's licence
s.44 Requirement for wholesale dealers to deal only with specified persons
s.46 Requirement for authorisation
s.50 Accompanying material
s.60 Conditions of UK marketing authorisation or parallel import licence : exceptional circumstances
s.67 Failure to place on the market etc
s.68 Revocation, variation and suspension of UK marketing authorisation or parallel import licence
s.69 Suspension of use etc of relevant medicinal product
s.104 Consideration of application
s.105 Conditions of certificate of registration
s.109 Failure to place on the market etc
s.128 Accompanying material
... and 77 more exemptions

🧪 Business Context Testing

What this means for your business

What you must do

Appointments 4

Appoint and maintain a qualified person for your medicine manufacturing licence

Appoint and maintain a qualified Responsible Person for your licence

Appoint and maintain a responsible person (import) for medicine imports

Appoint a qualified responsible person (import) for medicines

Risk assessment 1

Meet licensing criteria for medicinal manufacturing or wholesaling

Management duties 55

Audit your pharmacovigilance system regularly

Comply with GMP and maintain required records, notifications and testing for medicinal product manufacturing

Comply with GMP/GDP and obtain export confirmations for active substances

Comply with licence‑holder obligations for safe distribution of medicines

Comply with Ministers' notice on advertisement compatibility

Display notice of hub‑and‑spoke dispensing arrangements and keep written agreements

Do not approve suspended modular units or POC sites for manufacturing

Ensure appropriate and continued supply of registered medicines

Ensure compliant manufacturing at licensed modular units

Ensure compliant supply, storage and distribution of listed NIMAR medicines to Northern Ireland

Ensure continuous supply of authorised medicines

Ensure correct labelling of radionuclide medicines

Ensure GMP‑compliant import of medicines from non‑approved countries

Ensure homeopathic ads meet registration conditions

Ensure medicinal product adverts meet regulatory requirements

Ensure medicinal product packaging displays required information

Ensure ongoing supply of herbal medicines to pharmacies

Ensure required labeling on POC medicinal product packaging

Import medicines only from MHRA‑approved countries

Include NI availability statement in public ads for certain medicines

Keep manufacturing methods up to date and amend registration as needed

Keep medicinal product information up to date

Keep medicinal product information up to date

Keep pharmacovigilance records and report adverse reactions for exempt medicines

Keep pharmacovigilance records and report adverse reactions for POC medicines you sell

Keep product information up to date with current scientific knowledge

Label homoeopathic medicines as required by law

Label homoeopathic medicines with required wording and information

Label traditional herbal medicinal products correctly

Maintain an up‑to‑date pharmacovigilance system master file

Maintain GMP compliance for all medicinal product manufacturing

Maintain pharmacovigilance for EAMS medicines

Maintain pharmacovigilance system and submit safety reports

Maintain quality‑assuring facilities and notify the regulator of changes

Maintain traceability system and retain data for ATMPs

Manage product information, training and advertising records

Notify regulators before any public safety announcement

Obtain patient consent and licensing authority approval for EAMS data collection

Only manufacture POC medicines with licence and master file

Only manufacture under a licence and master file

Operate a pharmacovigilance system for your medicines

Provide Braille label and accessible leaflets for medicines

Provide compliant, user‑friendly package leaflets

Provide packaging & leaflets in English (or obtain exemption)

Provide required information and logo on your online medicinal product site

Provide required information for UKMA(NI) and ensure product is not sold in NI before authorisation

Review and update manufacturing methods for traditional herbal products

Review and update manufacturing methods to reflect scientific progress

Review and update registration when a new herbal monograph is issued

Sell specified medicines in limited‑size individual packs

Submit required data and observe sales embargo for similar biologics

Supply a detailed instruction leaflet with radionuclide medicines

Supply medicines only in child‑resistant, opaque containers

Update packaging to show “Great Britain only” label

Use only approved non‑promotional pictures on medicine packaging

Notifications 8

Notify licensing authority of market activity and provide sales data when requested

Notify licensing authority of market activity for your medicinal product

Notify MHRA of market placement, withdrawal and provide sales data

Notify the licensing authority if you want to be listed as a medicine supplier

Notify the licensing authority of urgent safety restrictions and apply for registration variation

Respond to licence review proposals within 28 days

Submit any substantial study protocol changes to the regulator before they’re made

Submit draft protocol for required safety study and obtain endorsement

Other requirements 6

Comply with notice to stop selling an unauthorised medicinal product

Do not sell or facilitate sale of suspended traditional herbal medicines

Do not sell or supply suspended medicines

Ensure herbal ads contain required statutory wording

Business Context Testing

Breach regulation 175 exceptions for human medicines