UK Medicines Manufacturing: Licences, GMP and the Qualified Person
Match your licence to what the site does, audit active substance suppliers and give the QP a complete batch file.
In Short
- QP certifies every batch.
- Audit active substance suppliers.
- GB and NI routes differ.
In the UK, the Human Medicines Regulations 2012 (SI 2012/1916) set licensing and GMP duties for manufacturers, importers and wholesale dealers. Since EU exit, Great Britain and Northern Ireland follow different routes for some provisions, and the Windsor Framework adds further detail not covered here. MHRA guidance and the GMP guidelines themselves were not opened. This guide summarises the regulations' revised text on legislation.gov.uk; it is orientation, not legal advice. Sources checked 4 Oct 2026.
Who needs a manufacturer's licence
Regulation 17(1) says a person may not, except under a manufacturer's licence of the appropriate type, manufacture or assemble a medicinal product, import one into Great Britain from a country other than Northern Ireland or an approved country for import, import one into Northern Ireland from outside the EEA, or possess a product for those activities. Regulation 17(1A) lists licence types for conventional products, imports, advanced therapies, special medicinal products and newer categories.
Roles under the 2012 Regulations
| Role | Regulation | Core duty |
|---|---|---|
| Manufacturer's licence holder | 17, 37 | Licensed activities; GMP; API supplier audits |
| Qualified person | 41, Schedule 7 | Batch certification |
| Wholesale responsible person | 45 | Licence conditions and product quality |
- Manufacturer's licence holder
- Regulation
- 17, 37
- Core duty
- Licensed activities; GMP; API supplier audits
- Qualified person
- Regulation
- 41, Schedule 7
- Core duty
- Batch certification
- Wholesale responsible person
- Regulation
- 45
- Core duty
- Licence conditions and product quality
More on who needs a manufacturer's licence
The licence type must match what the site actually does.
GMP and Active Substances
Regulation 37 requires the holder of a manufacturing licence to comply with the principles and guidelines of good manufacturing practice that apply under regulation B17. Active substances may be used as starting materials only if made under GMP for active substances and distributed under good distribution practice.
More on gMP and Active Substances
The licence holder must verify compliance of active substance manufacturers and distributors by audits, performed directly or by a contracted party, and check registration of suppliers where required. Audit reports and supplier approvals become part of the evidence an inspector reviews.
The Qualified Person
Regulation 41 requires every manufacturer's licence holder to have at least one qualified person at its disposal at all times, responsible for the duties in Part 3 of Schedule 7. In Great Britain, paragraph 12 makes the QP responsible for securing that each batch was manufactured and checked in line with the regulations and the UK marketing authorisation, and that batches imported from countries other than approved countries have undergone full qualitative analysis, quantitative analysis of active substances and other necessary tests.
Worked Example: QP File for Batch UKB-4417
More on the Qualified Person
Changes of QP need advance notice to the licensing authority.
Wholesale Dealers and Responsible Persons
Regulations 42 to 45 apply to wholesale dealer's licence holders. Regulation 43 requires compliance with good distribution practice guidelines, adequate staff, premises and equipment, notice of structural changes, and supply only of authorised products.
More on wholesale Dealers and Responsible Persons
Regulation 45 requires at least one responsible person with adequate knowledge and experience who ensures licence conditions are met and that product quality is maintained in line with the relevant authorisations. A manufacturer that also distributes needs both roles covered, with clear boundaries in procedures.
Worked Approach: Batch Certification File
Illustrative only. For batch UKB-4417, the certification file brings together the executed batch record, deviations and their closure, in-process and release test results, the marketing authorisation reference and the active substance supplier audit status.
More on worked Approach: Batch Certification File
The QP reviews it and records certification; the system can show what is complete or missing, but certification is the QP's personal decision under Schedule 7. Northern Ireland supply, import testing and approved-country lists need separate checks against the current text.
Questions
Who certifies a medicine batch in Great Britain?
The qualified person, who under Schedule 7 Part 3 paragraph 12 secures that each batch was manufactured and checked in line with the regulations and its UK authorisation.
Do UK manufacturers have to audit API suppliers?
Regulation 37 requires licence holders to verify GMP and GDP compliance of active substance manufacturers and distributors by audits, directly or through a contracted party.
Is a licence needed to import medicines into Great Britain?
Yes, from countries other than Northern Ireland or an approved country for import, a manufacturer's licence of the appropriate type is required under regulation 17.
What does a wholesale responsible person do?
Under regulation 45, they ensure licence conditions are met and that product quality is maintained in line with the relevant authorisations.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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