Division 21
Pharmaceuticals
Requirements for all pharmaceuticals
These requirements apply to all business activities in this division.
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.
Employers' Liability Insurance
Enforced by HSE
Employers' Liability (Compulsory Insurance) Act 1969
Compulsory for any business employing at least one person.
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.
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.
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.
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.
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.
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.