Sector
Life Sciences & Pharma
Pharmaceuticals, biotechnology, medical devices and clinical research.
Start here
Run a clinical trial under the 2026 UK regime
The new UK clinical-trials framework is now fully in force — combined review, new transparency duties
Set up a scientific research operation
Setting up a research operation
Medical device compliance quick check
If you make or supply medical devices
Set up as a pharmaceutical manufacturer
Licensing and GMP for pharmaceutical manufacture
Responding to a medical device safety incident
Device safety incident? Start here
Who regulates you
See all 14HSE (opens in a new tab)
Workplace health, safety, and welfare regulation across all industries. Enforces the Health and Safety at Work Act 1974 and related regulations. Investigates serious incidents …
Enforces 9 Acts this sector relies on.
MHRA (opens in a new tab)
Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.
Enforces 6 Acts this sector relies on.
SEPA (opens in a new tab)
Scotland's principal environmental regulator. Protects and improves Scotland's environment. Issues environmental permits for waste, emissions, water abstraction, and radioactive substances. Enforces environmental law and …
Enforces 5 Acts this sector relies on.
Environment Agency (opens in a new tab)
Environmental protection in England. Regulates waste, emissions, water quality, flood risk, and environmental permits for industrial activities. Enforces environmental law and issues permits for …
Enforces 3 Acts this sector relies on.
Home Office (opens in a new tab)
Government department responsible for immigration, security, and law and order. Administers UK Visas and Immigration (UKVI), issues sponsor licences for employers hiring overseas workers. …
Enforces 3 Acts this sector relies on.
OEP (opens in a new tab)
Independent body established post-Brexit to scrutinise environmental law and investigate complaints about public authorities' failures to comply with environmental law in England and Northern …
Enforces 3 Acts this sector relies on.
Key legislation
See all 24General rules
Common requirements that apply across industries. Conditions such as employing people or operating premises are shown only after they are known.
Meet your business waste duty of care
Every business that produces, stores or disposes of waste has a duty of care under section 34 of the Environmental Protection Act 1990, and stays responsible after it hands the waste on. Use only registered waste carriers, complete waste transfer notes correctly, and follow the stricter rules for hazardous waste.
Applies across industries.
General ruleFile your confirmation statement
File a confirmation statement every 12 months, within 14 days after your review period ends. Filing late is a criminal offence for the company and its officers.
Applies across industries.
General ruleVerify your identity for Companies House as a director or PSC
Yes, if you are an individual director or PSC of a UK company, or an individual director of an overseas company registered in the UK. Corporate directors and officers of corporate PSCs are not yet required to verify. The transition for existing directors and PSCs ends on 17 November 2026.
Applies across industries.
General ruleCheck if you need to register for VAT
You must register for VAT when your taxable turnover passes the registration threshold in any rolling 12 months, or when you expect it to pass the threshold within the next 30 days alone. Under the first test, register within 30 days of the end of the month. Late registration brings penalties and backdated VAT.
Applies across industries.
All guidance for life sciences & pharma
Compliance & Legal
7
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.
Relevant to a specific activity in this sector.
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.
Relevant to a specific activity in this sector.
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.
Relevant to a specific activity in this sector.
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.
Relevant to a specific activity in this sector.
Biocides and Pesticides Authorisation
Get HSE CRD authorisation for biocidal and pesticidal products.
Relevant to a specific activity in this sector.
CLP Chemical Classification and Labelling
Classify, label and package hazardous chemicals under GB CLP.
Relevant to a specific activity in this sector.
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.
Relevant to a specific activity in this sector.
Sector-Specific
2
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.
Relevant to a specific activity in this sector.
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.
Relevant to a specific activity in this sector.
Subsectors
SIC 2007 divisions covered by this sector.