| Guvnor

What this means for your business

15 obligations

11 penalties

7 can imprison

4 guides

Enforced by: MHRA
Applies to: United Kingdom
On this page: 15 compliance obligations, 4 practical guides

Read full text on legislation.gov.uk

What you must do

15 compliance obligations under this legislation — 7 can result in imprisonment.

Appointments 1

If your company runs a retail pharmacy, you must appoint a senior pharmacist (the superintendent) who has authority over the sale and supply of medicines, ensure a responsible pharmacist is in charge, display their name and registration at the premises, send a written statement to the regulator, and inform the regulator within 28 days if the superintendent leaves.

Trader/Business s.71 MHRA when your business operates a retail pharmacy and sells medicinal products

Management duties 5

You must make sure any medicines you produce, change or sell are not contaminated or have ingredients added or removed that could damage their composition. Supplying a product that has been altered in this way is a criminal offence.

Any Person s.63 MHRA When you manufacture, modify, or supply medicinal products

If your business sells, supplies or stores medicinal products, you must make sure they comply with any regulations on colour, shape or distinctive marks. You cannot put on the market a product that breaks those requirements. In practice this means checking labelling and product design before you buy or sell them.

Trader/Business s.88 MHRA When selling, supplying or holding medicinal products for sale

You must keep your pharmacy running safely and effectively at all times when you sell medicines or supply them in a retail‑sale‑like setting. This means having the right procedures, checks and supervision in place for every medicinal product you handle, whether it’s on the general sale list or not.

Any Person s.72AA MHRA

You must not sell or supply any medicinal product unless it is packed in a container that meets the requirements set out in the regulations (strength, material, shape, labelling, etc.). Any medicines you keep for sale must also be stored in compliant containers. Breaching this can lead to criminal prosecution.

Trader/Business s.87 MHRA when selling, supplying or possessing medicinal products for sale

If you sell medicines, you must make sure the product you provide matches the nature, quality and, for prescription items, the exact specifications the buyer expects. You cannot sell a product that is sub‑standard, contains unintended extra material, or has undisclosed additions or subtractions, unless the change is unavoidable and clearly labeled. This duty applies to all over‑the‑counter sales and to medicines supplied on prescription.

Trader/Business s.64 MHRA When selling or supplying any medicinal product (including on prescription)

Other requirements 1

You must not call yourself a chemist, pharmacist, or use the word ‘pharmacy’ unless you are running a registered pharmacy or are a qualified pharmacist. Likewise you cannot claim qualifications you don’t have in any advertising, signage or business name.

Trader/Business s.78 MHRA when you conduct retail sales of medicines or any goods and wish …

Payments and fees 1

If your pharmacy premises are listed on the official register, you must pay a yearly ‘retention fee’ for each year they remain registered. If you ignore a demand for the fee you have two months to pay, otherwise the Minister can have the premises removed from the register – you can get it restored by paying the fee and any prescribed penalty.

Trader/Business s.76 MHRA Premises are entered in the register under s.75 (i.e., you run a …

Offences and prohibitions 3

If you attach a warranty or a certificate of analysis to a medicine that actually relates to a different product, or give a purchaser a written warranty that you know is false, you commit a criminal offence. On conviction you can be fined (unlimited on indictment) and/or jailed for up to two years.

Any Person s.123 MHRA

If anyone who has accessed manufacturing processes or trade‑secret information – for example, staff, contractors or consultants who entered your site under the Medicines Act – shares that information with anyone else outside the strict performance of their duty, the business (or the individual) commits a criminal offence. On conviction the court can impose an unlimited fine and/or up to two years’ imprisonment. The offence can be tried either in the Magistrates’ Court (summary) or in the Crown Court (indictable).

Any Person s.118 MHRA

If you deliberately block a MHRA inspector, ignore a lawful request, or refuse to provide the assistance or information they reasonably need during an inspection, you commit a criminal offence. On summary conviction you can be fined up to £1,000. No prison term is attached to this breach.

Any Person s.114 MHRA

Registration and licensing 3

If your pharmacy premises have been taken off the official register under the Medicines Act, you must apply to have the entry restored. The application has to be made in the form and with the information the General Pharmaceutical Council requires, and you must be (or intend to be) lawfully operating a retail pharmacy at that location.

Trader/Business s.74C MHRA Your premises have been removed from the pharmacy register under s.74A(7) and …

If you run a pharmacy, your premises must be registered with the Medicines Registry. The registration is valid for one year and must be renewed each year, but only if the premises continue to meet the conditions set out in the Act. Failure to register or renew can lead to prosecution and unlimited fines.

Occupier s.74A MHRA Premises meet the conditions set out in section 74B of the Medicines …

If you run a retail pharmacy in Northern Ireland, you must apply to have your premises officially registered. You need to submit a prescribed application, pay the required fee and wait at least two months before the premises is entered on the register unless the Minister gives consent sooner. You may also have to respond to a notice from the Minister if the premises do not meet the relevant pharmacy regulations.

Trader/Business s.75 MHRA When you want to register a premises for a retail pharmacy in …

Reporting and filing 1

If you run a retail pharmacy business in Northern Ireland, you must send the registrar a list of every premises where you sell medicinal products each year. The list has to be sent during the month of January, keeping your registration information up‑to‑date.

Trader/Business s.77 MHRA if you operate a retail pharmacy business in Northern Ireland