Important Industry Diary Dates

The 2/7/2013 deadline has passed for the Falsified Medicines Directive and the need requirements for API manufacturers outside the EEA. Check out the MHRA web site for those countries ‘white listed’ and those requiring Letters of Confirmation. Focus is now moving toward manufacturers and suppliers of excipients.

The MHRA have also communcated the dates for their annual GMP & GDP conference on 2, 3 & 4th December 2013. This promises to be a key event for those working in the pharmaceutical industry. I hope that I will have the opportunity to meet with you at the event.
Finally in this update I can also confirm the dates for the Pharmig conference i.e. 20 & 21st November at the Oxford Belfry. Please check out the Pharmig website at or catch me on Linked In.

Keeping Abreast of Pharmaceutical Industry Initiatives

The PQG/MHRA held their annual Q&A meeting in London on 19th March and it provided the opportunity for PQG members, mainly QPs, to raise questions for discussion with the MHRA. As always, it was a great opportunity to learn and share information.

We need to review the FMD Excipient GMP guidance currently in draft for comment, and also the revised chapters of the EU Guide.

As we move towards the deadline of 02/07/13 for new rules on importation of API from outside the EU there are still unanswered questions for the pharmaceutical industry. Watch this space!

Finally, following on from the success of the Making Cosmetics Exhibition there is the possibility of establishing a Making Pharmaceuticals Exhibition, and through my work with Pharmig, MQAS will be involved in how this may develop.

The Falsified Medicines Directive – are you prepared?

New legislation was introduced on 2 January 2013 as part of Directive 2011/62 EU. This legislation will impact on most aspects of the pharmaceutical supply chain. There are implications for MA, WDL and MIA holders as well their excipient and active suppliers. Consideration will be given later to packaging.

The most immediate impact is for excipient and API manufacturers and suppliers with additional requirements for the application of GMP/GDP.

The MHRA have updates and further detail on their web site. Are you familiar with the requirements and do you have an action plan?