Life Sciences & Pharma

Manufacture controlled drugs and run a safe pharmaceutical site

A task guide for pharmaceutical manufacturers (SIC division 21) on the additional licence for controlled drugs and the duties that make a pharma site safe to run. It covers the Home Office controlled-drug licence, the environmental permit for large-scale chemical synthesis, and the workplace duties for hazardous substances, work equipment and general health and safety.

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UK-wide

An MHRA authorisation lets you make medicines, but it does not cover everything a pharmaceutical site has to do. If you make or handle controlled drugs you need an additional licence, and every manufacturing site carries duties for hazardous substances, process equipment and the general safety of the people who work there. This guide is for businesses in SIC division 21 and brings those duties together so you can run a safe, lawful site.

The controlled-drug licence applies across the whole United Kingdom, including Northern Ireland. The environmental permit and the workplace health-and-safety duties have a devolved split, so the regulator differs by nation — this guide names them as each comes up.

Get a Home Office controlled-drug licence if it applies

This is the substance-scoped step. If you produce, possess or supply controlled drugs — whether a controlled active substance or a finished controlled medicine — you need a domestic controlled-drug licence from the Home Office, in addition to your MHRA authorisation. The controls come from the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001, which place substances in schedules with matching production, storage, record-keeping and security requirements. If you handle no controlled substances, you can skip this step.

Get an environmental permit for large-scale synthesis

This step is scale- and substance-scoped. Large-scale chemical synthesis of basic pharmaceutical substances is a regulated installation activity that needs an environmental permit covering emissions to air and water and solvent use. Small-scale formulation lines are usually below the threshold. The permit is devolved: apply to the Environment Agency in England, Natural Resources Wales in Wales, the Scottish Environment Protection Agency (SEPA) in Scotland or the Northern Ireland Environment Agency (NIEA) in Northern Ireland. If you are unsure whether your synthesis needs a permit, confirm it with your environmental regulator before you commit.

Control hazardous substances on site

Pharmaceutical manufacture handles active ingredients, solvents, dusts and sensitisers. You must assess and control exposure to these hazardous substances, and carry out health surveillance where it is required. These duties are central to a pharma site and run for as long as you operate. They are enforced by the Health and Safety Executive (HSE) in Great Britain and by HSENI in Northern Ireland.

Keep process equipment safe and meet your general safety duties

Reactors, tabletting and filling lines, mixers and other process equipment must be suitable, maintained and safely guarded. Underneath the specific regimes sits your general duty to protect the health, safety and welfare of your employees and anyone else affected by the operation. Both duties apply at every pharma site and are enforced by the HSE in Great Britain and HSENI in Northern Ireland.

Steps to run a safe, lawful pharmaceutical site

Work through the steps in order. The controlled-drug licence and the environmental permit both take time to obtain, so start them early; the safety duties are standing obligations you maintain throughout.

  1. 1

    1. Identify which controls apply to your site

    Confirm whether you handle controlled drugs, whether your synthesis is a permitted installation, and which hazardous substances and process equipment you use. This sets the scope of what you must put in place.

  2. 2

    2. Apply for the Home Office controlled-drug licence

    If you make or handle controlled drugs, apply to the Home Office for the domestic licence for the relevant activity, and put the required security, records and standard operating procedures in place.

  3. 3

    3. Apply for the environmental permit if your synthesis needs one

    For large-scale synthesis, apply to your environmental regulator — the Environment Agency, Natural Resources Wales, SEPA or NIEA — before you operate, ready to show how you control emissions.

  4. 4

    4. Assess and control hazardous substances

    Complete your COSHH assessments for active ingredients, solvents, dusts and sensitisers, put the controls in place, and arrange health surveillance where it is required.

  5. 5

    5. Make your work equipment safe

    Confirm reactors, filling and tabletting lines and other process equipment are suitable, maintained and guarded, and that operators are trained to use them safely.

  6. 6

    6. Maintain your safety arrangements and records

    Keep the controlled-drug registers, permit monitoring records and health and safety arrangements current, and report losses or incidents as required. These duties continue for as long as you operate.

What to do next

The controlled-drug licence, the environmental permit and the safety duties sit on top of your MHRA authorisation — if you have not yet secured that, start with the guide on getting authorised to manufacture medicines. Before any production run, work through the pharmaceutical manufacturer compliance checklist to confirm every licence, permit and safety duty is in place. If you are unsure whether a substance is controlled or whether your synthesis needs a permit, confirm it with the Home Office or your environmental regulator before you commit — it is far cheaper to check than to operate without the right authorisation.

Official sources

Statutory sources and regulators for controlled drugs, permits and site safety

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