Medicines and Healthcare Products Regulatory Agency
Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2022
Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2022
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The Green Guide is the essential reference for pharmaceutical distributors, brokers, importers, and distributors in the UK. It provides European good distribution practices and UK guidance, information, and legislation. The 5th edition has been updated to incorporate changes after the UK's exit from the EU, including new guidance on pharmacovigilance, site naming, self-inspection, and the responsible person for import. It brings together EU guidance and the MHRA's expectations for compliance.
Format: Paperback / softback
Length: 400 pages
Publication date: 22 March 2022
Publisher: Pharmaceutical Press
The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors, also known as the Green Guide, serves as an indispensable resource for all distributors, brokers of human medicines, importers, and distributors of active substances in the United Kingdom. It offers a comprehensive compilation of European good distribution practices and UK guidance, information, and legislation pertaining to these activities. The fifth edition of this publication has been meticulously updated to reflect the changes that emerged following the United Kingdom's departure from the European Union on January 31, 2020. Furthermore, it incorporates valuable new guidance on pharmacovigilance for wholesalers, the identification of sites on a license, self-inspection procedures, and the responsible individual for import. This authoritative guide brings together EU guidance on good distribution practice with the expectations set forth by the MHRA, ensuring a seamless alignment between regulatory requirements and industry practices. Additionally, a user-friendly flowchart has been introduced to facilitate the registration process for handling active substances. By embracing the insights and recommendations provided in the 2022 edition of the Rules and Guidance for Pharmaceutical Distributors, stakeholders in the pharmaceutical industry can uphold the highest standards of distribution, safety, and compliance.
Weight: 782g
Dimension: 175 x 245 x 18 (mm)
ISBN-13: 9780857114419
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