Journey
Set up as a pharmaceutical manufacturer
Learning path for new pharmaceutical manufacturers. Work out which MHRA authorisation applies to what you make, get registered or licensed with a Qualified Person and Good Manufacturing Practice, add a Home Office licence and the right permits and safety controls for your site, and verify everything with a compliance checklist.
What this journey is for
Making pharmaceutical products means taking on the role of a regulated manufacturer in the eyes of UK medicines law. Before any product can be released, you become responsible for holding the right authorisation, working to Good Manufacturing Practice, and — if you handle controlled substances or run a large synthesis site — for getting additional licences, permits and safety controls in place first. This journey walks you through that path in the order you will live it, from working out which authorisation applies through to checking you have everything in place.
It does not give you the step-by-step instructions or the figures — those live in the guides it points to. It tells you where you are, why each stage matters, and which guide to open next. The Medicines and Healthcare products Regulatory Agency (MHRA) is the single authority that approves medicines across the whole UK, including Northern Ireland. There is one UK-wide route to follow throughout.
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Work out which authorisation applies
Start here, because what you make decides everything that follows. Active pharmaceutical ingredients, finished medicines and controlled drugs each engage a different regime, and a single site can engage more than one at once. Getting this picture right at the outset tells you which licences and registrations you are aiming for. It also stops you discovering a missed regime late, when a site is already built and expensive to change.
Which medicines manufacturing authorisation applies
Work out which authorisation applies to what you make. Active-substance registration for APIs, a manufacturer's / importer's authorisation for finished medicines, and an additional Home Office licence if you make or handle controlled drugs.
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Get authorised to manufacture medicines
This step comes before you make anything. Whether you register an active-substance activity or hold a manufacturer's / importer's authorisation for finished medicines, you must satisfy the MHRA before you produce a batch for release. The substance of this stage is building a Good Manufacturing Practice quality system and, for finished products, naming the Qualified Person who certifies each batch. The MHRA inspects the site before it grants the authorisation, so this work comes first.
Get authorised to manufacture medicines: MHRA licensing, active-substance registration and GMP
Get the right MHRA authorisation in place. Active-substance registration for makers of APIs, and the manufacturer's / importer's authorisation with a Qualified Person and Good Manufacturing Practice for makers of finished medicines.
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Add a controlled-drug licence and make the site safe
An MHRA authorisation lets you make medicines, but it does not cover everything a site has to do. If you make or handle controlled drugs you need a Home Office licence on top, and a large-scale synthesis site may need an environmental permit. Every site also carries duties for hazardous substances, process equipment and the general safety of the people who work there. The controlled-drug licence and the permit have the longest lead times, so treat them as something to arrange at the outset.
Manufacture controlled drugs and run a safe pharmaceutical site
Add the additional licence and the duties that make a pharma site safe. The Home Office controlled-drug licence, the environmental permit for large-scale synthesis, and the workplace duties for hazardous substances and process equipment.
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Verify you have covered everything
Once the moving parts are in motion, take a step back and check the whole picture holds together. A compliance checklist lets you confirm, in one place, that each authorisation, licence, permit and safety duty is genuinely met rather than assumed. Use it as your readiness review before your first production run. Come back to it as your range or processes change. Your obligations can shift when you add a new product, a controlled substance or a larger synthesis line.
Pharmaceutical manufacturer: compliance checklist
Verify you have covered everything before your first production run and as your range changes. Confirm each MHRA authorisation, controlled-drug licence, environmental permit and workplace safety duty is genuinely in place.
You will also need the general business set-up duties
Alongside the sector-specific path above, every manufacturing business carries a set of general obligations that are not unique to pharmaceuticals but are just as compulsory. As you build the business you will also need to:
- hold employers' liability insurance once you take anyone on. See the employers' liability insurance guide.
- handle personal data lawfully — most businesses must complete data protection registration with the ICO, with extra care where you process pharmacovigilance or clinical-trial data. See the register with the ICO guide.
- meet your fire safety duties for the premises you work from, which matter especially where you handle flammable solvents and reactive chemicals. See the fire safety responsibilities guide.
- treat your staff fairly and meet your equality duties across the protected characteristics in employment. See the equality in employment guide.
These general duties run in parallel with the sector path rather than after it, so set them up as you establish the business.
Where this leaves you
You now have the shape of the whole task. Work out which authorisation applies, get authorised with the MHRA, add a controlled-drug licence and the right permits and safety controls for your site, and verify the lot. All this happens alongside putting the general business set-up obligations in place around it. Work the four guides in order and you will have a clear, defensible position from your first licensed production run onwards.