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Rules and Guidance for Pharmaceutical Distributors (Green Guide)

Online Shop | Pharmaceutical Press | Practice: Law, Ethics and Regulation |  Rules and Guidance for Pharmaceutical Distributors (Green Guide)

Rules and Guidance for Pharmaceutical Distributors 2022 (The MHRA Green Guide)


In Paperback Format
Rules and Guidance for Pharmaceutical Distributors 2022 (The MHRA Green Guide)

£72.00
ISBN
9780857114419
Author
MHRA (Medicines and Healthcare products Regulatory Agency)
Published by
Pharmaceutical Press
Publication Date
March 2022
Edition
Fifth edition (2022)
Format
Paperback
Extent
400 pages
Dimensions
244 x 172 mm
Trade Tariff Code
490199

The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors, the MHRA 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 changes made after the UK’s exit from the European Union on the 31st January 2020.

It also incorporates new guidance on pharmacovigilance for wholesalers, the naming of sites on a licence, self-inspection, and the responsible person for import.

It brings together EU guidance on good distribution practice and the MHRA’s expectations for compliance. There is also a new flowchart for the registration of handling active substances.

Comprehensive new content includes:
  • Amended extracts from the Human Medicines Regulations 2012 relating to wholesale dealing, brokering medicine, importing and distributing active substances
  • UK guidance on complying with the EU guidelines on Good Distribution Practice for wholesale distributors and brokers of medicines and importers and distributors of active substances
  • UK guidance on risk-based inspections, conditions of holding a wholesale dealer’s licence, a broker registration, and an active substance registration, a responsible person for import and controls on certain medicinal products.

The MHRA Green Guide is compiled by the Medicines and Healthcare products Regulatory Agency. 


Online Shop | Pharmaceutical Press | Practice: Law, Ethics and Regulation |  Rules and Guidance for Pharmaceutical Distributors (Green Guide)

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