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Brexit regulatory support

Getting the best out of Brexit

Brexit regulatory support for conversion of marketing authorizations

The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country.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 can provide brexit regulatory support for your company along with bringing transparency into your regulatory 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. There will be a transition period till 31 December 2020. After the transition period, the MHRA cannot access these eCTDs anymore, they have to maintain their own copies of the eCTD.

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 Decentralised Procedure have a national registrations, based on eCTDs hosted by each National Competent Authority (NCA). Irrespective of the brexit, 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 brexit regulatory support 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.

Brexit regulatory support: other topics

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.

Also for these changes in your regulatory dossiers, Qdossier can provide brexit regulatory support.

More information

Marloes van der Geer

Marloes van der Geer
+31 416 707 998

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