| Titre : |
Rules and Guidance for Pharmaceutical Distributions |
| Type de document : |
texte imprimé |
| Auteurs : |
Medicines and Healthcare Products Regulatory Agency, Auteur |
| Editeur : |
London : Pharmaceutical Press |
| Année de publication : |
2022 |
| Importance : |
400p. |
| Présentation : |
ill. en coul. |
| Format : |
24x 21cm. |
| ISBN/ISSN/EAN : |
978-0-85711-441-9 |
| Langues : |
Anglais (eng) |
| Mots-clés : |
Rules Guidance Pharmaceutical Distributions |
| Index. décimale : |
614.4-87.1 |
| Résumé : |
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 is 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 in one chapter 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 and 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 Green Guide is compiled by the Medicines and
Healthcare products Regulatory Agency. Published by Pharmaceutical Press,
the publishing arm of the Royal Pharmaceutical Society.
|
| Note de contenu : |
figures;index |
Rules and Guidance for Pharmaceutical Distributions [texte imprimé] / Medicines and Healthcare Products Regulatory Agency, Auteur . - [S.l.] : London : Pharmaceutical Press, 2022 . - 400p. : ill. en coul. ; 24x 21cm. ISBN : 978-0-85711-441-9 Langues : Anglais ( eng)
| Mots-clés : |
Rules Guidance Pharmaceutical Distributions |
| Index. décimale : |
614.4-87.1 |
| Résumé : |
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 is 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 in one chapter 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 and 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 Green Guide is compiled by the Medicines and
Healthcare products Regulatory Agency. Published by Pharmaceutical Press,
the publishing arm of the Royal Pharmaceutical Society.
|
| Note de contenu : |
figures;index |
|  |
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