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Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2015 [electronic resource].

London : Pharmaceutical Press, 2015Description: electronic text (233 p.).ISBN: 9780857111722.Genre/Form: Print books.
Contents:
Cover -- Table of Contents -- Preface to the 2015 edition -- Changes to the Community Code -- UK legislation -- The Green Guide 2015 -- Acknowledgements -- Feedback -- Introduction -- Glossary of Legislation -- European Legislation -- UK Legislation -- MHRA -- MHRA: Licensing, Inspection and Enforcement for Human Medicines -- Overview of the Medicines and Healthcare Products Regulatory Agency Group -- Overview of MHRA -- Inspectorate -- The Data Processing Group -- Defective Medicines Report Centre (DMRC) -- Enforcement Group -- Compliance Management and Inspection Action Group -- Advice.
UK Guidance on the Manufacture, Importation and Distribution of Active Substances -- Introduction -- Registration -- Conditions of Registration as a Manufacturer, Importer or Distributor of an Active Substance -- GMP for Active Substances -- GDP for Active Substances -- Written Confirmation -- Waiver from Written Confirmation -- Procedure for Active Substance Importation -- Procedure for Waiver from Written Confirmation -- National Contingency Guidance -- National Contingency Guidance Submission Template -- Legislation on Manufacture and Importation.
EU Legislation on Manufacture and Importation -- DIRECTIVE 2001/83/EC, TITLE IV, MANUFACTURE AND IMPORTATION -- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use -- Title IV: Manufacture and Importation -- UK Legislation on the Manufacture, Importation and Distribution of Active Substances -- The Human Medicines Regulations 2012 (SI 2012/1916) -- Guidance on Wholesale Distribution Practice and Brokering Medicines.
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) -- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) -- Chapter 1 - Quality Management -- Chapter 2 - Personnel -- Chapter 3 - Premises and Equipment -- Chapter 4 - Documentation -- Chapter 5 - Operations -- Chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls -- Chapter 7 - Outsourced Activities -- Chapter 8 - Self-inspections -- Chapter 9 - Transportation -- Chapter 10 - Specific Provisions for Brokers.
Chapter 11 - Final Provisions -- ANNEX -- UK Guidance on Wholesale Distribution Practice -- The Application and Inspection Process "What to Expect" -- Risk-based Inspection Programme -- Conditions of Holding a Wholesale Dealer's Licence -- Appointment and Duties of the Responsible Person -- The Responsible Person Gold Standard -- UK Guidance on EU Guide Chapter 1 - Quality Management -- Controls on Certain Medicinal Products -- Control of Lisdexamfetamine, Tramadol, Zaleplon, Zopiclone and Reclassification of Ketamine -- Best Practice Temperature Monitoring -- Sales Representative Samples.
Handling Returns of Non-defective Medicinal Products.
Summary: This new 2015 edition of Rules and Guidance for Pharmaceutical Distributors (the Green Guide), provides you with a single source of guidance to, and legislation for, the distribution of medicines in Europe and UK. The Green Guide reproduces all the elements of the new Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 (the Orange Guide) that are relevant to distributors. So if you're involved in the wholesale supply, distribution and brokering of medicines for human use and the distribution of active substances, this is the one-stop guide you need.
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Cover -- Table of Contents -- Preface to the 2015 edition -- Changes to the Community Code -- UK legislation -- The Green Guide 2015 -- Acknowledgements -- Feedback -- Introduction -- Glossary of Legislation -- European Legislation -- UK Legislation -- MHRA -- MHRA: Licensing, Inspection and Enforcement for Human Medicines -- Overview of the Medicines and Healthcare Products Regulatory Agency Group -- Overview of MHRA -- Inspectorate -- The Data Processing Group -- Defective Medicines Report Centre (DMRC) -- Enforcement Group -- Compliance Management and Inspection Action Group -- Advice.

UK Guidance on the Manufacture, Importation and Distribution of Active Substances -- Introduction -- Registration -- Conditions of Registration as a Manufacturer, Importer or Distributor of an Active Substance -- GMP for Active Substances -- GDP for Active Substances -- Written Confirmation -- Waiver from Written Confirmation -- Procedure for Active Substance Importation -- Procedure for Waiver from Written Confirmation -- National Contingency Guidance -- National Contingency Guidance Submission Template -- Legislation on Manufacture and Importation.

EU Legislation on Manufacture and Importation -- DIRECTIVE 2001/83/EC, TITLE IV, MANUFACTURE AND IMPORTATION -- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use -- Title IV: Manufacture and Importation -- UK Legislation on the Manufacture, Importation and Distribution of Active Substances -- The Human Medicines Regulations 2012 (SI 2012/1916) -- Guidance on Wholesale Distribution Practice and Brokering Medicines.

Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) -- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) -- Chapter 1 - Quality Management -- Chapter 2 - Personnel -- Chapter 3 - Premises and Equipment -- Chapter 4 - Documentation -- Chapter 5 - Operations -- Chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls -- Chapter 7 - Outsourced Activities -- Chapter 8 - Self-inspections -- Chapter 9 - Transportation -- Chapter 10 - Specific Provisions for Brokers.

Chapter 11 - Final Provisions -- ANNEX -- UK Guidance on Wholesale Distribution Practice -- The Application and Inspection Process "What to Expect" -- Risk-based Inspection Programme -- Conditions of Holding a Wholesale Dealer's Licence -- Appointment and Duties of the Responsible Person -- The Responsible Person Gold Standard -- UK Guidance on EU Guide Chapter 1 - Quality Management -- Controls on Certain Medicinal Products -- Control of Lisdexamfetamine, Tramadol, Zaleplon, Zopiclone and Reclassification of Ketamine -- Best Practice Temperature Monitoring -- Sales Representative Samples.

Handling Returns of Non-defective Medicinal Products.

This new 2015 edition of Rules and Guidance for Pharmaceutical Distributors (the Green Guide), provides you with a single source of guidance to, and legislation for, the distribution of medicines in Europe and UK. The Green Guide reproduces all the elements of the new Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 (the Orange Guide) that are relevant to distributors. So if you're involved in the wholesale supply, distribution and brokering of medicines for human use and the distribution of active substances, this is the one-stop guide you need.

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