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Rules & Guidance for Pharmaceutical Manufacturers & Distributors

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Éditeur : Pharmaceutical Press

Support : Internet

Catégories :


Pharmacie, pharmacologie

Langue : Anglais


This is the very first digital version of Rules and Guidance for Pharmaceutical Manufacturers and Distributors.

Since its first publication in 1971 this text, commonly known as the “Orange Guide”, has been an essential reference for all involved in the manufacture or distribution of medicines in Europe. It is of particular relevance to all holders of manufacturer's licences and wholesale dealer's licences and to their Qualified Persons and Responsible Persons, who have a responsibility for ensuring compliance with the regulatory requirements.

The Orange Guide collates in one convenient, up-to-date and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. Changes to this edition include:

  • Detailed changes to the EU guide to good manufacturing practice

  • Detailed revisions to the EU Directive on medicinal products for human use

  • The new Directive on the Principles and Guidelines on Good Manufacturing Practice of Medicinal Products for Human Use
  • Compiled by the Inspection and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.

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    © 2017 Lavoisier-Datec