The 2017 Orange and Green Guides

The 2017 Orange and Green Guides are almost ready for publication.

2017 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors - the Orange Guide

As with the previous publications this 10th edition continues to bring together existing and revised Commission written material concerning the manufacture, importation, distribution and brokering of human medicines and matters relating to the manufacture, importation and distribution of active substances.

The 2017 edition the guide has been updated with revised sections on:

1. qualification of suppliers and customers;

2. parallel importation and parallel distribution;

3. temperature control and monitoring;

4. UK legislation; and

5. matters relating to unlicensed medicines.

There are also new MHRA sections on:

1. GMP for Excipients;

2. Guidance on revised Annex 16 of GMP; and

3. MHRA Data Integrity definitions and guidance for Industry. The guidance complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.

Revised Annex 15 and 16 are included.

Also included is new Commission guidance on;

1. principles and guidelines of Good Manufacturing Practice for active substances;

2. principles of Good Distribution Practice of active substances;

3. setting health based exposure limits; and

4. formalised risk assessment for ascertaining the appropriate GMP for excipients.

The EU regulation on safety features for medicines is added together with two Commission Q&As on:

1. importation of active substances; and

2. safety features for medicinal products.

There is also a new appendix on sources of useful information.

2017 Orange Guide

Pre order your copy of the 2017 Orange Guide here.  Order before 31st December using code MHRA17 to receive free postage.

2017 edition of Rules and Guidance for Pharmaceutical Distributors - the Green Guide

This is the fourth edition of the Rules and Guidance for Pharmaceutical Distributors known as the Green Guide issued by MHRA. As with the previous editions the Green Guide continues to bring together existing and revised Commission-written material concerning the distribution and brokering of human medicines and matters relating to the manufacture, importation and distribution of active substances.  In this edition we have reordered the sections to bring specific subject matter together to help you to get the most out of the guide.

This 2017 edition has revised sections on:

1. qualification of suppliers and customers;

2. controls on certain medicinal products;

3. parallel importation and parallel distribution;

4. the application and inspection process for new licences “what to expect”;

5. updated UK legislation; and

6. temperature control and monitoring.

There are also new sections on:

1. the guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01);

2. matters relating to unlicensed medicines;

3. sourcing and exporting medicinal products – non-EEA countries;

4. data integrity; and

5. the EU regulation on safety features for medicines.

Two Commission Q&As have been added:

1. importation of active substances; and

2. safety features for medicinal products.

There are also two new appendices on:

1. sources of useful information; and

2. licensing requirements for import into the UK and export from the UK including introduced medicine – wholesale supply only.

2017 Green Guide

Pre order your copy of the 2017 Green Guide here. Order before 31st December using code MHRA17 to receive free postage.