These requirements apply to all business activities in this division.
compliance
Great_Britain
Ongoing
Health and Safety at Work etc. Act 1974 — general duties
Enforced by:
HSE
Health and Safety at Work etc. Act 1974
General duty to protect the health, safety and welfare of employees and others affected by the manufacturing operation. Devolved: Health and Safety at Work (Northern Ireland) Order 1978.
insurance
Great_Britain
Annual
Employers' Liability Insurance
Enforced by:
HSE
Employers' Liability (Compulsory Insurance) Act 1969
Compulsory for any business employing at least one person.
registration
Uk
Annual
UK GDPR + Data Protection Act 2018
Enforced by:
ICO
Data Protection Act 2018; UK GDPR (retained EU law)
Applies to any business processing personal data — staff, customers, suppliers. ICO registration unless specifically exempt. Pharmacovigilance and clinical-trial data carry additional special-category data obligations.
compliance
Great_Britain
Ongoing
Equality Act 2010 — protected characteristics
Enforced by:
EHRC
Equality Act 2010
Discrimination, harassment and victimisation prohibited across the protected characteristics, in employment and in the provision of services. Devolved: separate NI equality regime.
compliance
England_Wales
Ongoing
Regulatory Reform (Fire Safety) Order 2005
Enforced by:
LOCAL_FIRE_AUTHORITY
Regulatory Reform (Fire Safety) Order 2005
The responsible person must carry out a fire risk assessment and maintain fire-safety arrangements — material in plants handling flammable solvents and reactive chemicals. Devolved: Fire (Scotland) Act 2005; Fire and Rescue Services (NI) Order 2006.
compliance
Great_Britain
Ongoing
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
Enforced by:
HSE
Control of Substances Hazardous to Health Regulations 2002
Central to pharmaceutical manufacture: assess and control exposure to hazardous substances, active pharmaceutical ingredients, solvents, dusts and sensitisers; health surveillance where required. Devolved: COSHH Regulations (Northern Ireland) 2003.
compliance
Great_Britain
Ongoing
Provision and Use of Work Equipment Regulations 1998 (PUWER)
Enforced by:
HSE
Provision and Use of Work Equipment Regulations 1998
Reactors, tabletting and filling lines, mixers and other process equipment must be suitable, maintained and safely guarded.
compliance
Great_Britain
Ongoing
Manual Handling Operations Regulations 1992
Enforced by:
HSE
Manual Handling Operations Regulations 1992
Avoid or assess and reduce the risk of injury from manual handling of raw materials, drums, sacks and finished-product loads.