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Brexit regulatory support

Getting the best out of Brexit

Conversion of marketing authorizations

In the event of a no-deal Brexit, the marketing authorization holders (MAH) and Medicines and Healthcare products Regulatory Agency (MHRA) have to convert the Marketing Authorizations obtained through the EU Centralised Procedure (CP) to a National Authorization, before the end of 2020 or sooner, depending on a product’s lifecycle. This requires baseline eCTDs for all CP products. Qdossier is the preferred partner to bring transparency in your dossiers.

Products registered through an EU Centralised Procedure

Products registered through the Centralised Procedure have a pan-EU registration, based on eCTDs hosted at the EMA. By the time that the MHRA cannot access these eCTDs anymore, they have to maintain their own copies of the eCTD. Nobody know whether there will be a Brexit deal or not. And if it turns out that there is a deal, nobody knows how that looks like. Would it be similar to that between the EU and Norway; or to that between the EU and Switzerland; will there be a deal that is UK-specific? Therefore, the MHRA and MAHs have to get prepared for a no-deal Brexit at 31 January 2020.

Highly likely, there will be a transition period till 31 December 2020. An Initiating sequence (baseline eCTD) has to be submitted by the end of this transition period. Until this baseline submission has been submitted and validated, it is not possible to make any changes to the UK marketing authorizations. So actually, it is more likely that baseline eCTDs have to be submitted rather sooner than later. The initiating sequence must minimally include a baseline of whatever has been submitted in eCTD to the EMA. In addition, a summary list of all historical regulatory activities has to be provided. Qdossier recommends to take the opportunity to create a company core dossier that serves as the basis for all countries and fulfills the need of the MHRA as a bonus. Focusing solely on the UK would be, like the British say ‘Penny-wise – Pound-foolish’

Qdossier has prepared many baselines for big and small pharma (refer to Use Case on Tool implementation Project number 2). MAHs received complete and transparent eCTDs for their products. They showed a clear current state, but more importantly, it allowed them to maintain the eCTD in a consistent and transparent manner. MAHs were able to created baselines from their eCTDs to expand to other countries.  For them, the UK is just another country.

Products registered through an EU Mutual Recognition- or Decentralised Procedure

Products registered through the Mutual Recognition- and Decntralised Procedure have a national registrations, based on eCTDs hosted by each National Competent Authority (NCA).  Irrespective whether there is a deal or not, the MHRA has access to the dossiers. However, for the MAHs these dossiers are likely to divert when the MHRA are not included in an MRP or DCP anymore. How as industry can you manage this diversion and create two parallel streams of eCTDs; one for the MRP/DCP and one for the MHRA?

Qdossier can help you deciding how to do this and provide services to actually do this. However, the MAHs have to decide which option fits best:

  1. Continue the MHRA eCTD starting with Sequence 0000, a new UUID, and cross refer to all previous sequences under the original UUID
  2. Repurpose all existing sequences and continue with the next available sequence number using a different UUID
  3. Resubmit all individual MRP/DCP sequences with a new UUID and continue the lifecycle
  4. As for the CP, create a baseline and start from Sequence 0000.

There are pros and cons for all options and Qdossier can help you to take an informed decision.

Other Brexit-related topic

MAHs might have to transfer the role of Reference Member State from the UK, to a remaining EU country. 

MAHs might have to transfer the role of an UK MAH for an product registered under a MRP/DCP to another MAH in a remaining EU country.

Qdossier can provide the services to prepare and submit those dossiers.

More information

Marloes van der Geer
+31 416 707 998
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