MHRA licensing for medicines and medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood products in the UK. If you manufacture, import, distribute, or supply these products, you likely need MHRA authorisation.

This guide covers licensing requirements for pharmaceutical and medical device businesses operating in the UK market.

Medicines manufacturing (MIA)

A Manufacturer's Licence (MIA) is required to manufacture medicines in the UK. This includes manufacturing finished products, active pharmaceutical ingredients (APIs), or carrying out partial manufacturing steps like packaging, labelling, or quality testing.

Manufacturer's Licence (MIA) Fees

MHRA fees for medicines manufacturing authorisation

Standard MIA application fee: £4,209
Non-orthodox practitioner (NOP) MIA: £245
Change of ownership fee: £461
Annual periodic fee: £561
GMP inspection daily rate: £5,251
Processing time: 90 working days from complete application
GMP inspection: Mandatory pre-licence inspection for all new applicants
Licence validity: Indefinite (if retained with annual fees)
Qualified Person requirement: Mandatory - pharmacy/chemistry/biology degree + 2 years experience

Apply for Manufacturer's Licence (MIA)

Step-by-step process for obtaining MHRA medicines manufacturing authorisation

Determine licence scope required – Identify manufacturing activities (sterile/non-sterile, biologics, etc.). Determine if manufacturing for clinical trials (MIA(IMP)) or commercial (MIA). Check if activities include importation, packaging, testing, or batch release.
Appoint Qualified Person(s) – Recruit or designate QP with appropriate qualifications (pharmacy/chemistry/biology degree plus 2 years practical experience). Multiple QPs required for 24/7 operations.
Establish Quality Management System – Implement GMP-compliant QMS covering all manufacturing operations. Prepare site master file, develop SOPs for all activities, and implement deviation, CAPA, and change control systems.
Prepare manufacturing premises – Design/modify facilities to meet GMP standards (appropriate cleanroom grades A-D). Install environmental monitoring systems, qualify all critical equipment (IQ, OQ, PQ), and establish cleaning validation programmes.
Submit online application via eBSI portal – Register on MHRA's electronic submission system and complete MIA application form with full details of manufacturing site, proposed activities, QP details, and QMS documentation. Upload supporting documents.
Pay application fee – Submit payment of £4,209 (standard MIA) via online portal and retain payment confirmation.
Respond to MHRA assessment queries – MHRA assesses application (typically 60 working days before inspection). Respond promptly to any requests for clarification or additional information.
Undergo GMP inspection – MHRA schedules on-site inspection (typically within 90 working days). Inspection covers all aspects of GMP compliance, typically 2-5 days duration at £5,251 per day. Present documentation, demonstrate processes, and provide facility tour.
Address inspection findings – Receive inspection report with critical/major/minor observations. Prepare CAPA plan for all observations and submit to MHRA within 14 days. Implement corrective actions before licence grant.
Receive licence and maintain compliance – MHRA issues Manufacturer's Licence (MIA) if compliant. Display licence at manufacturing site and pay annual periodic fee (£561) each year. Subject to ongoing GMP inspections (typically every 2-3 years).

HEALTHCARE & SOCIAL CARE Requirement

All manufacturers must comply with Good Manufacturing Practice (GMP) as detailed in the EU GMP Guidelines (still applicable in UK). Key requirements include:

Quality Management System covering all manufacturing activities
Qualified Person (QP) responsible for batch release
Appropriate premises, equipment, and personnel
Written procedures and batch documentation
Regular self-inspection and quality audits

MHRA conducts pre-licence inspections and ongoing inspections (typically every 2-3 years) to verify GMP compliance. Inspection fees are £5,251 per day.

Who this applies to: All manufacturers holding or applying for MIA or MIA(IMP) licences

Enforcement: Non-compliance can result in licence suspension, licence revocation, or prosecution. Manufacturing without a licence carries unlimited fines and up to 2 years imprisonment.

Medicines wholesale distribution (WDA)

A Wholesale Dealer's Licence (WDA) is required to procure, hold, and distribute medicines to other licensed entities such as pharmacies, hospitals, or other wholesalers.

Wholesale Dealer's Licence (WDA) Fees

MHRA fees for medicines wholesale dealing authorisation

Annual periodic fee (standard): £346
Annual periodic fee (reduced/GSL): £206
GDP inspection daily rate: £5,251
Processing time: 90 working days from complete application
GDP inspection: Mandatory pre-licence inspection for Good Distribution Practice compliance
Licence validity: Indefinite (if retained with annual fees)
Responsible Person requirement: Mandatory - registered pharmacist, pharmacy technician, or equivalent

Apply for Wholesale Dealer's Licence (WDA)

Step-by-step process for obtaining MHRA medicines wholesale dealing authorisation

Determine wholesale activities scope – Identify products to be distributed (POM, P, GSL medicines). Determine if importing from outside UK. Assess if dealing in controlled drugs (requires separate Home Office licence).
Appoint Responsible Person (RP) – Recruit/designate RP meeting MHRA requirements (registered pharmacist, pharmacy technician, or equivalent EU qualification). RP must be present at premises during working hours and oversees GDP compliance.
Establish Quality Management System – Implement GDP-compliant QMS covering all distribution operations. Develop SOPs for receipt, storage, dispatch, returns, and recalls. Establish temperature monitoring, deviation, CAPA, and Falsified Medicines Directive (FMD) compliance procedures.
Prepare wholesale premises – Secure suitable premises with adequate storage conditions. Install temperature/humidity monitoring systems. Establish segregated quarantine and rejected stock areas. Implement security measures to prevent theft and falsified medicines.
Submit online application via eBSI portal – Register on MHRA's electronic submission system and complete WDA application form including wholesale site address, product categories, Responsible Person details, and QMS overview. Upload supporting documents (RP CV, site plan, GDP procedures).
Pay application fees – Submit payment via online portal and retain payment confirmation.
Undergo GDP inspection – MHRA schedules on-site GDP inspection covering storage conditions, record-keeping, RP oversight, and FMD compliance. Typically 1-2 days duration at £5,251 per day. Demonstrate receipt and dispatch procedures and present supplier/customer due diligence records.
Address inspection findings – Receive GDP inspection report with observations. Prepare CAPA plan for critical/major/minor findings. Submit CAPA plan to MHRA (typically within 14 days) and implement corrective actions.
Receive licence and maintain compliance – MHRA issues Wholesale Dealer's Licence (WDA) specifying authorised premises, RP name, and scope. Display licence at wholesale premises and pay annual periodic fee (£346 standard or £206 reduced). Subject to ongoing GDP inspections.

HEALTHCARE & SOCIAL CARE Requirement

All wholesale dealers must comply with Good Distribution Practice (GDP). Key requirements include:

Responsible Person (RP) - typically a registered pharmacist
Appropriate premises with controlled temperature/humidity
Quality Management System and documented procedures
Supplier and customer due diligence
Falsified Medicines Directive (FMD) compliance
Cold chain management for temperature-sensitive products

MHRA conducts GDP inspections to verify compliance. Non-compliance can result in licence suspension or revocation.

Who this applies to: All wholesale dealers holding or applying for WDA licences

Enforcement: Operating without a WDA where required is a criminal offence carrying unlimited fines and up to 2 years imprisonment.

Clinical trial authorisation

Before conducting clinical trials involving investigational medicinal products (IMPs) in the UK, you must obtain Clinical Trial Authorisation (CTA) from MHRA. You also need favourable opinion from a Research Ethics Committee.

Clinical Trial Authorisation (CTA) Fees and Timelines

MHRA fees and processing times for clinical trial applications

CTA fee (Phase I, full/simplified IMPD): £4,656
CTA fee (Phase IV, cross-referral, additional protocol): £343
CT variations/amendments fee: £343
Annual safety reports assessment: £343
Processing time (regulatory clock): 30 days from validated application
Validation period: Up to 10 days for completeness check
SUSAR reporting (serious/unexpected): 15 calendar days
Fatal/life-threatening SUSAR: 7 days initial + 8 days follow-up
Annual safety report: Mandatory for all ongoing trials

Apply for Clinical Trial Authorisation (CTA)

Step-by-step process for obtaining MHRA clinical trial authorisation

Prepare Investigational Medicinal Product (IMP) – Manufacture IMP under GMP conditions (MIA(IMP) or equivalent). Ensure IMP specifications and quality documentation available. Prepare IMP labelling per Annex 13 GMP requirements and arrange qualified person batch release.
Compile clinical trial dossier – Prepare Investigational Medicinal Product Dossier (IMPD), complete clinical protocol with full methodology, prepare Investigator's Brochure (IB), compile non-clinical safety data (pharmacology, toxicology), and prepare quality documentation.
Obtain ethics committee approval – Submit application to NHS Research Ethics Committee and await favourable ethics opinion (separate timeline from MHRA). Address any ethics committee queries.
Submit CTA application to MHRA – Use MHRA online submission portal. Complete EudraCT number application if not already assigned. Submit CTA application form with IMP details, IMPD, clinical protocol, Investigator's Brochure, non-clinical overview, quality documentation, and copy of favourable ethics opinion.
Pay CTA fee – Submit fee: £4,656 for Phase I trials with full IMPD, £343 for Phase IV or additional protocols. Payment via online portal.
MHRA validation (Day 0-10) – MHRA validates application for completeness. May request additional information during validation (clock stops). Validation complete: CTA application date confirmed.
MHRA assessment (Day 0-30) – MHRA reviews clinical, non-clinical, and quality aspects within 30-day regulatory clock. MHRA may send 'Grounds for Non-Acceptance' listing concerns. Sponsor may respond with clarifications/amendments.
Respond to Grounds for Non-Acceptance (if received) – Review MHRA concerns (typically received Day 14-21). Prepare detailed response addressing each point. May include protocol amendments or additional data. Submit response within specified timeframe.
Receive MHRA decision (Day 30) – Three possible outcomes: Acceptance (CTA granted), Further Grounds for Non-Acceptance (additional concerns), or Rejection (rare). If accepted, receive CTA number and formal authorisation letter.
Commence trial and maintain compliance – Ensure both MHRA CTA and ethics approval in place. Submit annual safety reports to MHRA (£343). Report SUSARs per timelines (15 days, or 7 days for fatal). Submit substantial amendments to MHRA as needed (£343 fee per amendment).

Combined MHRA/Ethics approval pathway

The MHRA now offers a combined MHRA and Ethics Committee review option for clinical trial applications, reducing overall approval time. This integrates the regulatory and ethics approval processes.

For Phase 3 and 4 trials meeting certain criteria, the New Notification Scheme allows trials to proceed within 14 days if no objection received.

Medical device registration (UKCA marking)

All medical devices placed on the Great Britain market must be registered with MHRA. Post-Brexit, devices require UKCA marking (UK Conformity Assessed), though CE marked devices remain accepted during transition periods.

Medical Device Registration Fees (UKCA Marking)

MHRA fees for medical device manufacturer and device registration

Statutory registration fee (current): £261 per application
Maximum devices per application: 100 device types, 20,000 products
New fee structure (from 1 April 2026): Approximately £300 per year per Level 2 GMDN Category
Device registration requirement: All devices placed on UK market must be registered
Registration update deadline: 10 working days for any changes
Technical file retention: Minimum 10 years after last device placed on market
UK Responsible Person (UKRP): Mandatory for non-UK manufacturers
Clinical investigation fee (Class I and IIa): £15,309
Clinical investigation fee (Class IIb implantable/long-term invasive): £24,617
Clinical investigation fee (Class III and active implantable): £32,016
Clinical investigation amendment fee: £0 (no fee for amendments from 16 July 2025)
Average clinical investigation approval time: 51 calendar days

UKCA Marking Deadlines and CE Mark Recognition

Transition timelines for medical device conformity marking in Great Britain

CE marking recognition (medical devices): Until 30 June 2028
CE marking recognition (IVDs): Until 30 June 2030
UKCA mandatory from: 1 July 2028 (medical devices) / 1 July 2030 (IVDs)
Northern Ireland: CE marking required (UKCA alone not valid)
UK Approved Body requirement: Class IIa, IIb, III devices
Class I devices: Self-certification by manufacturer
MHRA consultation (2025): Proposal for indefinite CE mark recognition under consideration

Key dates: The MHRA has extended recognition of CE marked medical devices in Great Britain. Devices with valid CE certification under EU MDR/IVDR will be accepted until 30 June 2028 (general medical devices) or 30 June 2030 (IVDs), whichever is earlier if certificate expires. The MHRA is consulting on potentially making CE mark recognition indefinite.

Northern Ireland: Due to the NI Protocol, devices must bear a CE mark to be placed on the NI market. UKCA marking alone is not sufficient for Northern Ireland.

Register Medical Devices with MHRA (UKCA Marking)

Step-by-step process for registering medical devices for the Great Britain market

Determine device classification – Classify device per Medical Device Regulations (Class I, IIa, IIb, III). Higher classes (IIa/IIb/III) require UK Approved Body involvement. Active implantable and IVD devices have separate classification rules.
Conduct conformity assessment – Class I (non-sterile, non-measuring): Self-assessment by manufacturer. Class I (sterile/measuring): Partial UK Approved Body assessment. Class IIa, IIb, III: Full UK Approved Body assessment required. Prepare technical documentation, conduct clinical evaluation, and establish QMS (ISO 13485).
Engage UK Approved Body (if required) – Select UK Approved Body appropriate for device type. Submit application for conformity assessment. Undergo design examination and/or QMS audit. Address any non-conformities. Receive certificate of conformity.
Prepare technical documentation – Compile comprehensive technical file including device description, design and manufacturing information, risk management file (ISO 14971), clinical evaluation report, labels and instructions, and declaration of conformity. Retain for minimum 10 years.
Affix UKCA marking (or retain CE mark during transition) – Apply UKCA mark to device (or packaging if impractical). Include UK Approved Body number if applicable. CE marking accepted until 30 June 2028 (medical devices) or 30 June 2030 (IVDs).
Register as manufacturer with MHRA via DORS – Create account on the MHRA Device Online Registration System (DORS). Complete manufacturer registration including organisation details and Single Registration Number (SRN). Pay registration fee (£261 per application until 31 March 2026; annual GMDN-based fee from 1 April 2026).
Register each device – Submit device registration via DORS for each device/device family. Provide: device name and model, GMDN code, risk class, intended purpose, UK Approved Body details and certificate number (if applicable), and UKCA/CE certificate reference. Registration must be completed BEFORE placing device on market.
Appoint UK Responsible Person (if non-UK manufacturer) – Non-UK manufacturers must appoint UK Responsible Person (UKRP). UKRP must be UK-established and acts as liaison with MHRA. UKRP assumes regulatory responsibilities for devices. Register UKRP details with MHRA.
Implement post-market surveillance and vigilance reporting – Establish PMS system proportionate to device class. Register for the MHRA MORE (Medical Online Reporting Environment) portal for incident reporting. Report serious incidents within statutory timelines — 2 days (serious public health threat), 10 days (death/unanticipated serious deterioration), 15 days (other serious incidents). Enhanced PMS requirements in force from 16 June 2025.
Maintain ongoing compliance – Keep technical documentation current. Update device registrations within 10 working days of any changes. Renew UK Approved Body certificates before expiry. Respond to MHRA inspections and requests for information.

Pharmacovigilance requirements

All Marketing Authorisation Holders (MAHs) must have a pharmacovigilance system to monitor the safety of their medicines post-authorisation.

Pharmacovigilance Requirements for Marketing Authorisation Holders

Mandatory pharmacovigilance obligations for medicines licence holders

Qualified Person for Pharmacovigilance (QPPV): Mandatory for all Marketing Authorisation Holders
Pharmacovigilance System Master File (PSMF): Required and must be permanently available to MHRA
Serious ADR reporting (UK-occurring): 15 calendar days
Unexpected serious ADR reporting (worldwide): 15 calendar days
Fatal/life-threatening ADR (clinical trial): 7 days initial + 8 days follow-up
Periodic Safety Update Report (PSUR): Frequency defined in Marketing Authorisation conditions
QPPV availability: Continuously available (24/7 contactable)
PSMF update deadline: Within 30 days of changes to PV system
Response to MHRA requests: Typically within 7 days

Penalties for non-compliance

MHRA Penalties and Enforcement Powers

Penalties for non-compliance with medicines and medical devices regulations, distinguishing between medicines offences and device offences.

MHRA uses a graduated enforcement approach from informal advice through warning letters and statutory notices to criminal prosecution. The Medicines and Medical Devices Act 2021 introduced modern enforcement tools including civil monetary penalties as an alternative to prosecution.

MEDICAL DEVICES: Breach of UK MDR or enforcement notice: Up to 6 months imprisonment and/or unlimited fine
MEDICAL DEVICES: Civil monetary penalty (alternative to prosecution): Variable amount set by MHRA under MMD Act 2021, Section 31
MEDICAL DEVICES: Supplying falsified medical device: Up to 2 years imprisonment and/or unlimited fine (Consumer Protection Act 1987)
MEDICINES: Manufacturing without licence: Unlimited fine + up to 2 years imprisonment
MEDICINES: Wholesale distribution without licence: Unlimited fine + up to 2 years imprisonment
MEDICINES: Falsified medicines supply: Unlimited fine + up to 10 years imprisonment
BOTH: Obstruction of MHRA inspector: Criminal offence — unlimited fine (Consumer Rights Act 2015, Schedule 5)
Enforcement escalation: Informal advice → warning letters → compliance notices (s.24) → suspension notices (s.25) → safety notices (s.26) → recall notices (s.28) → civil sanctions (s.31) → criminal prosecution

Business Context Testing

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Guvnor

MHRA licensing for medicines and medical devices

Medicines manufacturing (MIA)

Good Manufacturing Practice (GMP) compliance is mandatory

Medicines wholesale distribution (WDA)

Good Distribution Practice (GDP) compliance is mandatory

Clinical trial authorisation

Combined MHRA/Ethics approval pathway

Medical device registration (UKCA marking)

Pharmacovigilance requirements

Penalties for non-compliance

MHRA online services

Compliance Assistant

🧪 Business Context Testing

◉ Content Graph

Medicines manufacturing (MIA)

Good Manufacturing Practice (GMP) compliance is mandatory

Medicines wholesale distribution (WDA)

Good Distribution Practice (GDP) compliance is mandatory

Clinical trial authorisation

Combined MHRA/Ethics approval pathway

Medical device registration (UKCA marking)

Pharmacovigilance requirements

Penalties for non-compliance

MHRA online services

Related guides in MHRA Authorisation

Business Context Testing

Content Graph