You cannot make medicines first and seek approval later. Before you manufacture, assemble or import any pharmaceutical product, you must hold the right authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA). This guide is for businesses in SIC division 21 and covers the two MHRA regimes: registration for makers of active substances, and the manufacturer's / importer's authorisation (MIA) for makers of finished medicines.
Which one you need depends on what you make. If you are unsure, work through the router guide on which medicines manufacturing authorisation applies first, then come back here. The MHRA authorises medicines across the whole United Kingdom, including Northern Ireland, so there is one UK-wide route to follow.
Register if you make active pharmaceutical ingredients
If you manufacture, import or distribute active substances — the active pharmaceutical ingredients used in finished medicines — you must register that activity with the MHRA before you start. Registration confirms you work to Good Manufacturing Practice for the manufacture of active substances, or Good Distribution Practice where you import or distribute them. This is separate from the authorisation for finished products, and a maker of APIs that does not go on to make finished medicines needs this registration rather than an MIA.
Hold a manufacturer's / importer's authorisation for finished medicines
If you manufacture, assemble or import finished medicinal products, you need a manufacturer's / importer's authorisation (MIA). The site must operate to Good Manufacturing Practice, name a Qualified Person (QP) who certifies each batch before it is released, hold a site master file, and pass periodic MHRA GMP inspection. Manufacturing or importing medicines without an MIA is an offence, so the authorisation must be in place before you produce any batch for release.
Steps to get authorised
Work through the steps in order. The MHRA inspects the site before granting an authorisation, so the practical work of building the quality system and naming your Qualified Person comes before you can be licensed.
-
1
1. Confirm which regime applies
Decide whether you make active substances, finished medicines, or both. Makers of active pharmaceutical ingredients register the active-substance activity; makers of finished medicines need an MIA. Many sites need both.
-
2
2. Build your Good Manufacturing Practice quality system
Put in place the premises, equipment, procedures and documentation that GMP requires — a site master file, batch records, validated processes and quality controls. This is the substance of what the MHRA inspects.
-
3
3. Appoint your Qualified Person
For a finished-product MIA, name a Qualified Person who is eligible to certify batches for release. The QP is a named, accountable role, so identify and secure this person early.
-
4
4. Register the active-substance activity, if it applies
If you make, import or distribute active substances, register that activity with the MHRA before you start, confirming you work to GMP or Good Distribution Practice for active substances.
-
5
5. Apply to the MHRA for your MIA, if you make finished medicines
Submit the MIA application to the MHRA. The agency will arrange a GMP inspection of the site before deciding whether to grant the authorisation. If you make only active substances, your route is the registration at step 4, not an MIA.
-
6
6. Pass inspection and maintain the authorisation
Host the MHRA GMP inspection, close any findings, and then keep the quality system, the QP arrangement and the registration current. Periodic re-inspection applies for as long as you operate.
What to do next
If you make or handle controlled drugs, you need a Home Office licence on top of your MHRA authorisation, and your site must meet the workplace and process safety duties that come with handling hazardous substances — see the guide on manufacturing controlled drugs and running a safe pharmaceutical site. Before any production run, work through the pharmaceutical manufacturer compliance checklist to confirm the authorisation, the quality system and the supporting duties are all in place. If you are unsure whether a finished medicine or an active substance is what you make, confirm it with the MHRA before you commit.
Official sources
Statutory sources and MHRA guidance on medicines manufacturing authorisations
- Human Medicines Regulations 2012 (opens in a new tab)
- MHRA — apply for a manufacturer or wholesaler of medicines licence (opens in a new tab)
- MHRA — register as a manufacturer, importer or distributor of active substances (opens in a new tab)
- MHRA — good manufacturing practice and good distribution practice (opens in a new tab)