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New Green guide

Essential reading for pharmacy-owner GPs

March 9th 2017

Tagged: Pharmacy owners' news

By Ailsa Colquhoun

MHRA ‘orange’ and ‘green’ guides have been revised and updated.

The Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors), now in its tenth edition, contains information and legislation relating to the manufacture and distribution of human medicines.

The Green Guide (Rules and Guidance for Pharmaceutical Distributors) reproduces all the elements of the new orange’guide that are relevant to distributors, such as pharmacy owner GPs.

This tenth edition of the green guide includes new sections on:
• the guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)
• matters relating to unlicensed medicines
• sourcing and exporting medicinal products – non-EEA countries
• data integrity
• the EU regulation on safety features for medicines

It includes revised sections on:
• qualification of suppliers and customers
• controls on certain medicinal products
• parallel importation and parallel distribution
• the application and inspection process for new licences: “what to expect”
• updated UK legislation
• temperature control and monitoring.

New orange guide content includes:

• qualification of suppliers and customers
• parallel importation and parallel distribution
• temperature control and monitoring
• UK legislation
• unlicensed medicines

New MHRA sections on:
• GMP for excipients
• guidance on revised Annex 16 of GMP
• data Integrity definitions and guidance for industry

New commission guidance on:
• principles and guidelines of GMP for active substances
• principles of GDP of active substances
• setting health based exposure limits
• formalised risk assessment for ascertaining the appropriate GMP for excipients.