GovWire

Aimed at manufacturers and distributors of human medicines the Orange and Green Guides have been revised and updated to keep industry informed of the latest regulations.

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) provides information on the broader distribution of human medicines.

Mark Birse, Group Manager in MHRAs Inspection, Enforcement and Standard Division said:

Ensuring that safe and high quality medicines are being made and distributed is vitally important.

This provides the trust needed by patients and healthcare professionals to use them.

Both new editions have been revised and updated with the latest pharmaceutical regulations, directives and guidance.

These updated guides will help companies understand the regulatory environment in which they operate, follow good practice and stay compliant with the law.

The new 2017 edition of the Orange Guide has been updated to incorporate changes and additions made to the detailed European Community guidelines on Good Manufacturing Practice (GMP) and the revised EU Guidelines on Good Distribution Practice (GDP).

There are new sections on:

• GMP for excipients
• guidance on revised Annex 16 of GMP
• data Integrity definitions and guidance for industry

The new 2017 edition of the Green Guide provides a single source of guidance to, and legislation for, the distribution of medicines in Europe and UK.

There are 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

Order the Orange and Green Guides

The Orange and Green Guides are available to be ordered from Pharmaceutical Press. They are also both available online via MedicinesComplete

Background

1. Medicines and Healthcare products Regulatory Agencyis responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health.

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