Regulations & guidance - Introduction

Advice on regulatory, pharmaceutical, nutritional and legal issues is one of the most widely used PAGB services.  PAGB responds to thousands of queries from its members each year and through its working groups and task forces, helps develop proposals for regulation which are proportionate, while ensuring the highest standards of consumer safety. 

The regulatory and legal affairs team monitors the national and international framework of laws, regulations, guidelines and principles governing OTC medicines, food supplements and herbal medicines.  The association is proactive in its approach to regulations and research-based in developing proposals and responses to consultations.

PAGB liaises with national, European and worldwide regulatory bodies, as well as other national and international trade associations and working parties / committees of other healthcare and related stakeholders. 

The regulatory and legal affairs department advises on a wide range of issues including:

• Licensing (e.g. legal status, branding, POM to P, P to GSL, combinations, OTC indications, data requirements and UK and European licensing procedures)
• Packaging (labelling, leaflets and child resistant packaging)
• Food supplement legislation
• The 'borderline' between medicines, foods and cosmetics
• Herbal medicines
• Health claims for food supplements

For further information please contact Helen Darracott, PAGB Director of Legal and Regulatory Affairs on 020 7242 8331.