Life Sciences & Pharma UK-wide

Which medicines manufacturing authorisation applies

A reference router for pharmaceutical manufacturers (SIC division 21). Use it to work out which authorisation regime applies to what you make: active-substance registration for active pharmaceutical ingredients, a manufacturer's / importer's authorisation with a Qualified Person and GMP for finished medicines, and an additional Home Office licence if you make or handle controlled drugs.

Guide summary

Check what you make to find out which licence you need. Register with the MHRA if you make active ingredients. Get a manufacturer's or importer's authorisation (MIA) if you make or import finished medicines. Get a Home Office licence if you handle controlled drugs. You may need more than one licence at the same site.

  • Register active substance activities with the MHRA before you start
  • Comply with Good Manufacturing Practice (GMP) for making active ingredients
  • Get a Manufacturer's or Importer's Authorisation (MIA) for finished medicines
  • Appoint a Qualified Person (QP) to certify each batch of medicine
  • Permit the MHRA to inspect your site
  • Get a Home Office controlled-drug licence if you make or handle controlled drugs
  • Follow security, record-keeping and procedure rules for controlled drugs
  • More than one licence can apply at the same site
  • The MHRA is the single UK authority for medicines authorisations
On this page

Related guides in General Compliance

If you make pharmaceutical products, the authorisation you need depends on what you make, not just that you make medicines. This router is for businesses in SIC division 21 — the manufacture of basic pharmaceutical products and pharmaceutical preparations. Use it to identify which regime bites on your activity, then open the task guide that tells you how to satisfy it.

More than one regime can apply at the same site. A business that makes a finished medicine from a controlled active substance needs both a finished-product authorisation and a Home Office controlled-drug licence. Work through the three questions below and note every regime that applies to you.

The medicines regimes apply across the whole United Kingdom, including Northern Ireland. The Medicines and Healthcare products Regulatory Agency (MHRA) is the single authority that approves medicines throughout the UK, so there is one UK-wide route rather than separate routes for Great Britain and Northern Ireland.

Do you make active pharmaceutical ingredients?

If you manufacture, import or distribute active substances — the active pharmaceutical ingredients (APIs) used in medicines — you must register that activity with the MHRA and work to Good Manufacturing Practice or Good Distribution Practice for active substances. This is the basic-pharmaceutical-substance regime at SIC 21.1, and it is separate from the authorisation for finished medicines. If you only make APIs, this is your primary regime.

Do you make, assemble or import finished medicines?

If you manufacture, assemble (including packaging and labelling) or import finished medicinal products for human use, you need a manufacturer's / importer's authorisation (MIA) from the MHRA. The site must operate to Good Manufacturing Practice, name a Qualified Person (QP) who certifies each batch before release, and pass periodic MHRA inspection. This is the finished-product regime at SIC 21.2, distinct from active-substance registration above.

Do you make or handle controlled drugs?

This regime is substance-scoped: it applies only if you produce, possess or supply controlled drugs, whether as a controlled active substance or a finished controlled medicine. If so, you need a Home Office controlled-drug licence in addition to any MHRA authorisation, with security, record-keeping and standard-operating-procedure duties. A line making only non-controlled products — paracetamol API, for example — does not need this licence. If you handle no controlled substances, skip this regime.

What to do next

Once you know which regimes apply, open the task guides. To get the MHRA authorisation or registration in place, see the guide on getting authorised to manufacture medicines. If you make or handle controlled drugs, or you need to bring the site itself up to standard, 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 every obligation is in place. Large-scale chemical synthesis of basic pharmaceutical substances may also need an environmental permit, which is covered in the controlled-drugs-and-safe-site guide and the checklist.

Official sources

Statutory sources and regulators for medicines and controlled-drug authorisations