Rules and Guidance for Pharmaceutical Distributors 2015: The Green Guide, 3rd Edition

The Comprehensive Guide to Pharmaceutical Distribution in Europe

The “Green Guide” for Pharmaceutical Distributors is an indispensable resource for professionals responsible for distributing medicinal products within the European Union. It meticulously compiles relevant sections from the comprehensive “Orange Guide” (Rules and Guidance for Pharmaceutical Manufacturers and Distributors), focusing specifically on the wholesale supply and distribution of medicines for human use.

Authored by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s leading drug regulatory body, the Green Guide serves as an authoritative reference for good distribution practice and wholesale distribution. It incorporates the latest EU Guidelines on Good Distribution Practice, ensuring alignment with the most up-to-date regulatory requirements.

This indispensable guide provides a concise yet comprehensive overview of the pharmaceutical regulations, directives, and guidance that manufacturers and wholesalers must adhere to when distributing medicinal products in Europe. It meticulously outlines the requirements for maintaining high standards of quality, safety, and efficacy throughout the supply chain.

The Green Guide seamlessly integrates the following essential components:

• EU Legislation: A comprehensive summary of relevant European Union directives and regulations governing the distribution of pharmaceuticals, including the Good Distribution Practice Directive (94/C 65/03) and the Falsified Medicines Directive (2011/62/EU).
• UK Legislation: A detailed overview of UK-specific regulations that complement EU frameworks, such as the Medicines Act 1968 and the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 2004.
• Guidance: Authoritative guidance on good distribution practice, wholesale distribution, and the practical implementation of regulatory requirements. This includes best practices for storage, handling, transportation, and documentation.

By meticulously outlining the regulatory landscape and providing practical guidance, the Green Guide empowers pharmaceutical manufacturers and wholesalers with the knowledge and tools to ensure the safe and compliant distribution of medicinal products across Europe. It serves as a vital resource for maintaining the integrity of the pharmaceutical supply chain and protecting the health and well-being of European citizens.