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The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors, the 'Green Guide', is the essential reference for all distributors, brokers of human medicines, importers and distributors of active substances in the UK.It provides you with the single authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities.The new 5th edition has been updated to incorporate chan...

The 2022 edition of Rules and Guidance for PharmaceuticalManufacturers and Distributors, known as "The Orange Guide", is theessential reference for all manufacturers and distributors of medicines in theUK.

Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK drug regulatory body, MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It contains EU guidance on good manufacturing and good distribution ...

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, MHRA, and contains official EU guidance on good distribution practice and wholes...

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This essential reference guide relates to pharmacovigilance of medicinal products for human use. It complements currently available EU legislation and guidance and provides practical advice to key stakeholders, in particular Marketing Authorisation Holders, about achieving an appropriate system of pharmacovigilance. Contents include: roles and responsibilities of the EEA Qualified Person for Pharmacovigilance, managing case reports and other s...