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+420 224 910 672

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+420 226 251 459

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Hlášení nežádoucích príhod

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Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:

+420 224 910 672

(09.00-17.30 CET)

+420 226 251 459

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

Brexit – Stick or Twist?

The EU Commission is working on overdrive at present to encourage pharma companies to take heed of the looming Brexit deadline.Last month, Brexit arrived at the all-important 12-month mark until inception, and the EU commission is concerned that MA holders are taking a far too reactive approach to the situation by not choosing to initiate plans to devote time, money and resources to Brexit preparations. It seems that many MA holders are waiting to see if there will be a softening or even delay to Brexit; however the EU Commission has real fears that this approach poses a high risk in terms of supply delays or shortages should such negotiations not materialise and Brexit move forward as per its original trajectory. In fact, in a recent technical seminar summary the EU commission states that “many MAHs have not yet taken the necessary regulatory actions, [such as] marketing authorizations transfers, relocation of QPPV etc. While recognising the complexity of some of these procedures for companies to put in motion, there seems to be also a ‘wait and see’ approach by the MAHs.”

Conversely, we are seeing that some national agencies such as the MEB are making formal provisions for the loss of the MHRA as a result of Brexit by looking at options for sharing the increased workload on the EMA as a result of Brexit. At present, the MHRA takes the lion’s share of procedures that are “less interesting from a scientific perspective” and therefore less sought-after by member states. Last year, the MEB increased its capacity to accept more work, but rather than continuing this trend they are looking to help equip other agencies in order to spread the workload. There have also been recruitment drives by agencies in Spain, Denmark and other countries, thus affording the EMA a broader pool of talent to draw on after Brexit than in the past. MEB is working to further enhance the pool by helping agencies from smaller countries that joined the EU more recently to build up their regulatory capacity. Interest in this program has exceeded expectations, with 10-member states – not the anticipated five – signing up to receive MEB’s support.

From the above we can see that there is an imbalance in the way the industry vs the regulatory bodies are handling Brexit preparations, and there is genuine concern that there will be a mad dash to the finish line the closer we get to Brexit. Here at ELC Group we have a dedicated Regulatory team that can help you with your Brexit plans and strategies, and we are happy to have an informal discussion with anyone on how to better plan for the inevitable. Time is pressing and although many companies seem to wish to stick with the status quo, we highly recommend that some planning with a variable degree of commitment is undertaken from now, so to be better prepared for all eventualities.

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