Complied by the Medicines and Healthcare products Regulatory Agency (MHRA), this new publication provides guidance for distributors of medicines for human use in Europe."Rules and Guidance for Pharmaceutical Distributors" reproduces those elements of the 2007 edition of "Rules and Guidance for Pharmaceutical Manufactures and Distributors" (commonly known as the "Orange Guide") specific to the wholesale supply and distribution of medicines for human use. Essential information to ensure the safe distribution of medicines and the safety of the public is provided in this new guide. "Rules and Guidance for Pharmaceutical Distributors 2007" includes: EU guidelines on Good Distribution Practice; UK guidance on wholesale distribution practice; EU legislation on wholesale distribution; and, UK legislation on wholesale distribution.
Sprache
Verlagsort
Zielgruppe
Maße
Höhe: 244 mm
Breite: 172 mm
ISBN-13
978-0-85369-758-9 (9780853697589)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Section I: Medicines and Healthcare products Regulatory Agency; 1. MHRA: Licensing, Inspection and Enforcement for Human Medicines; Section II: Guidance on Wholesale Distribution Practice; 2. EU Guidance on Wholesale Distribution Practice; 3. UK Guidance on Wholesale Distribution Practice; Section III: Legislation in Wholesale Distribution; 4. EU Legislation on Wholesale Distribution; 5. UK Legislation on Wholesale Distribution; Section IV: Glossary of Legislation.