Main description:

This title is an essential reference work for all those involved in the distribution of medicines in Europe. It reproduces relevant parts of Rules and Guidance for Pharmaceutical Manufacturers and Distributors (commonly known as the Orange Guide) specific to wholesale supply and distribution of medicines for human use. It is compiled by the UK drug regulatory body, the MHRA, and contains official EU guidance on good distribution practice and wholesale distribution along with relevant information on EU and UK legislation. It brings together the main pharmaceutical regulations, directives and guidance which manufacturers and wholesalers are expected to follow when distributing medicinal products within Europe. This 2015 edition of Rules and Guidance for Pharmaceutical Distributors (the Green Guide) has been updated to incorporate the revised EU Guidelines on Good Distribution Practice.

Contents:

1. MHRA: Licensing, Inspection and Enforcement for Human Medicines; 2. UK Guidance on the Manufacture, Importation and Distribution of Active Substances; 3. EU Legislation on Manufacture and Importation; 4. EU Legislation on Manufacture and Importation and Distribution of Active Substances; 5. Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01); 6. UK Guidance on Wholesale Distribution Practice; 7. UK Guidance on Brokering Medicines; 8. EU Legislation on Wholesale Distribution and Brokering Medicines; 9. UK Legislation on Wholesale Distribution; 10. UK Legislation on Brokering Medicines.