Business guidance

Rules, requirements and how-tos for running your business — organised by topic, with industry-specific guidance on the sector pages.

Guidance for life sciences & pharma

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Retail & Consumer Goods

Biocides and Pesticides Authorisation

Get HSE CRD authorisation for biocidal and pesticidal products.

Retail & Consumer Goods

CLP Chemical Classification and Labelling

Classify, label and package hazardous chemicals under GB CLP.

Manufacturing & Engineering

Control and monitor air emissions

If your industrial activity releases pollutants to air, you need an environmental permit from the Environment Agency or your local authority, depending on its tier. The permit sets emission limits, monitoring and reporting duties, and operating without it or breaching it is an offence carrying up to five years in prison.

Food, Drink & Hospitality

Get authorisation for a water activity in Scotland (EASR)

In Scotland, any activity affecting surface water or groundwater, such as abstraction, engineering or discharges, needs SEPA authorisation, and doing it without one is a criminal offence. SEPA decides which of four risk-based tiers your activity falls into, from general binding rules to a permit.

Life Sciences & Pharma

Get authorised to manufacture medicines

Making finished medicines without a manufacturer's authorisation from the MHRA is an offence. To get one you need a Qualified Person, Good Manufacturing Practice and an MHRA inspection, and active-substance makers must register separately.

Healthcare & Social Care

Manage medicines and controlled drugs safely

Prescription-only medicines may be supplied or given only on a prescriber's direction or under a lawful patient group direction. Controlled drugs add rules on locked storage, registers and destruction, and a privately funded provider needs a Home Office licence to hold Schedule 2 stock.

Life Sciences & Pharma

Manufacture controlled drugs and run a safe pharmaceutical site

Making or handling controlled drugs needs a Home Office licence on top of your MHRA authorisation. Large-scale chemical synthesis also needs an environmental permit, and every site must control hazardous substances and keep its process equipment safe.

Life Sciences & Pharma

Meet your scientific research regulatory duties

Which duties apply depends on the research you do. Labs using hazardous chemicals or biological agents must control exposure under COSHH, and work with GMOs, protected animals, stored human tissue or ionising radiation each brings its own licence or notification.

Retail & Consumer Goods

MHRA authorisation for medicines and medical devices

Making, distributing or selling medicines or medical devices in the UK needs MHRA authorisation. Medicines need a marketing authorisation for each product, manufacturers a manufacturer's licence and distributors a wholesale dealer licence, while device makers register their devices; since 1 January 2025, authorisations cover the whole UK.

Life Sciences & Pharma

Which medicines manufacturing authorisation applies

To make or import finished medicines, you need a manufacturer's/importer's authorisation from the MHRA and a Qualified Person to certify every batch. Making active ingredients needs a separate MHRA registration, and controlled drugs also need a Home Office licence.

General rules

Common requirements shown separately from guidance directly classified to this sector.