Falsified Medicines Directive
MHRA have just posted an announcement regarding its “contingency plans that would allow the Agency, in cases where there is an overriding need to ensure continued supply of specific ASs after 2 July 2013, to provide an opinion on the importation of the AS to permit manufacture, QP certification and supply of finished medicinal products”.
Australia’s white listing has just been posted on the Commission website.
Brazil’s application for white listing has now entered the assessment stage, though they will not be white listed before 02-Jul-2013. They should be issuing written confirmations in the interim.
MHRA stated at the GMP/GDP consultative committee meeting on 19-Apr-2013 that there have been delays in transposition of the Directive into UK legislation and this may not now be in place by 02-Jul. This does NOT change the obligation to comply with the primary (EU) legislation from that date.
MHRA shared with Industry representatives a contingency proposal that they have developed to ensure ongoing supplies in the event of issues with written confirmations/white listing as of 02-Jul. They are taking this to the Heads of EU Medicines Agencies (HMA) meeting this week, where it will be discussed with any other ideas brought by other representatives. It is recognised that an EU-wide solution is needed and that time is short. Outcome will be shared as soon as possible.
Note that any contingency arrangements will be time limited and that we should continue to pursue written confirmations for our imported active substances by first intent. If you have not yet made all your suppliers aware of the requirements and encouraged them to engage with their regulatory agency, then please do so as soon as possible.
The Commission’s Q&As document is now at version 4.1 and may be accessed via the European Commission website. This version replaces a version 4.0 which was issued briefly and included a Q&A relating to atypical actives over which some further Member State discussions are required.
India’s procedures for the issue of written confirmations have now been issued (10-Apr) and are accessible via the link provided with the 10-Mar update.
The European Commission’s Pharmaceutical Committee has issued an update, dated 27-Mar-2013, on ‘the state of play’ with regard to the top 18 countries for API exports to the EU, plus South Africa and Ukraine. There are also some additional Q&As. Read it here.
The EC white list table has been updated. Singapore have NOT been white listed at this time due to the fact that their GMP certification scheme is non-mandatory. However, they will issue written confirmations.
The Indian Central Drugs Standard Control Organisation (CDSCO), which has been nominated as the competent authority for the issue of written confirmations for active substances manufactured in India, has recently issued a series of guidelines detailing how it will comply with the relevant FMD requirements. These may be found at http://cdsco.nic.in/API%20WC2013.htm
China have now formally announced that SFDA will issue written confirmations. However, no details of guidelines or process to be followed have yet been issued.
Public consultation guideline documents for risk assessment of excipients and good distribution practices for active substances were published by the Commission on 06-Feb and may be found HERE
New versions of the Commission’s Q&A document (v3) and written confirmation template (v2) were published yesterday and are now accessible via the Commission website link above. You will also see that the USA have now applied for white listing and are undergoing assessment (17-Jan).
The MHRA held a stakeholder meeting on the Falsified Medicines Directive (FMD) on June 11th 2012 and the presentation and Q&A session documents issued from that meeting are listed below:
A further meeting with Industry representatives was held on 15-Nov-2012, with the primary focus being on active substance requirements. Notes from this meeting are linked below. PQG were thanked for providing several questions which will form the basis of a new Q&A page on MHRA’s website.
If you are wanting to keep track of applications and approvals for ‘white listing’, then keep an eye on this European Commission website and scroll to the bottom of the page.