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HDA UK Media And Political Bulletin – 6 December 2016

The 2017 Orange and Green Guides

MHRA Blog, Mark Birse, 2 December 2016

 

The MHRA offers a preview of the 2017 Orange and Green Guides, ahead of their publication early 2017. The 10th edition of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 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 Green Guide, Rules and Guidance for Pharmaceutical Distributors, is in its 4th edition.

 

MHRA’s festive facts about fake medicines

P3 Pharmacy, 5 December 2016

 

The MHRA has published an advent calendar with facts about fake medicines. The FakeMeds campaign (#FakeMeds) is raising awareness of the risks of buying fake medicines and medical devices, and encouraging young adults not to buy from unsafe and unregistered online sources.

 

Parliamentary Coverage

House of Commons Questions, 5 December 2016, Drugs: Manufacturing Industries

 

Barry Gardiner: What assessment the Government has made of the potential for additional costs or complexities for medicines manufacturers in securing separate regulatory approval for products for the UK and the EU after the UK leaves the EU.

 

Department of Health

David Mowat: The Government is fully assessing how the United Kingdom’s decision to leave the European Union will impact on medicines regulation in the UK. No decision has yet been made on the future of UK medicines regulation. Therefore, we cannot speculate on future regulatory processes or costs for medicines manufacturers.

 

Full Coverage

The 2017 Orange and Green Guides

MHRA Blog, Mark Birse, 2 December 2016

 

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:

 

  • qualification of suppliers and customers;
  • parallel importation and parallel distribution;
  • temperature control and monitoring;
  • UK legislation; and
  • matters relating to unlicensed medicines.

 

There are also new MHRA sections on:

 

  • GMP for Excipients;
  • Guidance on revised Annex 16 of GMP; and
  • 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;

 

  • principles and guidelines of Good Manufacturing Practice for active substances;
  • principles of Good Distribution Practice of active substances;
  • setting health based exposure limits; and
  • 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:

 

  • importation of active substances; and
  • safety features for medicinal products.
  • There is also a new appendix on sources of useful information.

 

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:

 

  • 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; and
  • temperature control and monitoring.

 

There are also 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; and
  • the EU regulation on safety features for medicines.

 

Two Commission Q&As have been added:

 

  • importation of active substances; and
  • safety features for medicinal products.

 

There are also two new appendices on:

 

  • sources of useful information; and
  • licensing requirements for import into the UK and export from the UK including introduced medicine – wholesale supply only.

 

MHRA’s festive facts about fake medicines

P3 Pharmacy, 5 December 2016

 

The public is being targeted with messages about the dangers of fake medicines in an online advent calendar that reveals a ‘festive fact’ about counterfeit medicines each day until Christmas.

 

The social media campaign – part of an ongoing ‘FakeMeds’ initiative – has been produced by the Medicines and Healthcare products Regulatory Agency (MHRA).

 

Don’t turn to ‘dodgy diet pills’ bought from an unknown website, always buy condoms with a CE mark and from trusted sources, and don’t risk organ damage from using unlicensed tanning injections sourced online, are some of the messages found behind the calendar doors so far this month.

 

The FakeMeds campaign (#FakeMeds) is raising awareness of the risks of buying fake medicines and medical devices, and encouraging young adults not to buy from unsafe and unregistered online sources.

 

The public should report products or websites they believe to be fake to the counterfeit hotline on 020 3080 6701 or email counterfeit@mhra.gsi.gov.uk, says MHRA.

HDA UK Media And Political Bulletin – 6 December 2016

From Factory to Pharmacy

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