Regulatory Affairs

Regulatory and Legal Affairs is concerned with the national and international framework of laws, regulations, guidelines and principles governing OTC medicines and food supplements, as well as interpreting and applying these statutory and other requirements for member companies. The regulatory and legal framework for pharmaceuticals is monitored on an on-going basis, at both national and international levels, to ensure controls remain at an appropriate level to allow the responsible industry to flourish. This involves two-way communication with PAGB member companies and official bodies responsible for regulating the industry. PAGB ensures that members are kept informed of all relevant developments and contribute views for industry's position.

The Regulatory and Legal Affairs department advises on a wide range of issues, including the following:-

• Licensing (legal status, branding, POM to P, P to GSL, combinations, OTC indications, data requirements and confidentiality, taste testing and European mutual recognition)
• Packaging (labelling, leaflets and child resistant and tamper evident packaging)
• Food supplement legislation
• The 'borderline' between medicines, foods and cosmetics
• Herbal medicines
• Health claims for food supplements

The key external contact points are:

• National regulatory authorities such as Medicines and Healthcare Products Regulatory Agency (MHRA), the Department of Trade and Industry (DTI), Department of Health (DH) and the Ministry of Agriculture and the Food Standards Agency (FSA)
• The European Commission and the Committee for Medicinal Products for Human Use (CHMP), directly and through AESGP (the Association of the European Self-Medication Industry)
• Worldwide representation through World Federation of Proprietary Medicine Manufacturers (WFPMM), World Health Organisation (WHO) and the United Nations (UN) and the Trans Atlantic Business Dialogue (TABD)
• Other National and International Trade Associations active in related areas such as food, advertising, cosmetics and other healthcare sectors
• Working Parties or Committees of other healthcare and related stakeholders such as pharmacy, media, legal and consumer

The key internal contact points (i.e. within the membership) are:-

• Member company legal, regulatory and medical personnel
• General managers and marketing and sales managers mostly within the UK but also at European level
• Members of any current PAGB Working Parties or members of the PAGB Regulatory and Medical Panels
• External advisors and service companies assisting member companies, such as lawyers, PR and advertising agencies 

Regulatory and Legal Services to Members

The services to members form a key part of PAGB’s activities and take up a large proportion of the time of those within the Regulatory and Legal Affairs Department. The range of services on offer includes:

• Confidential telephone, E-mail and written advice on regulatory, pharmaceutical, nutritional and legal issues
• Attendance by invitation to assist with company projects
• Presentations to members, privately or at members meetings
• Guidelines and position papers on areas of relevance to industry
• Database containing listings of products and companies in membership
• Mailings with summaries of the key issues, documents and events
• Preparing industry positions and programmes where necessary for particular OTC ingredients and product categories
  

Advice on regulatory, pharmaceutical, nutritional and legal issues is one of the most widely used PAGB services. Literally thousands of enquiries are answered each year. However, all PAGB services are developed to meet identified industry and member company needs