Joel Mitchell

Marketing Authorisation Holders, the impact of the UK’s decision to invoke Article 50 of the Treaty on European Union. How could this affect MAH’s products currently registered in the UK and EU?

Earlier this month the European Medicines Agency (EMA) issued a notice to Marketing Authorisation Holders (MAHs) of centrally authorised products (1). In this notice the agency brings to the attention of MAHs, some of the legal repercussions, which will need to consider in preparation for 30 March 2019, 00:00 (CET).  Using this notice as a basis, we would like to discuss further the points presented by the EMA and explain the steps to be taken in order to comply.

EU law requires that MAHs are established in the EU (or EEA) (1).  Depending on a company’s structure and network, this law could have a large impact.  For example, if a company’s current EU office is UK based, come March 2019, this office would no longer be considered to be within the EU.  In order to overcome this a company may need to extend/relocate to another EU member state, or alternatively seek professional support for a Marketing Authorisation Holding service.  Once this decision has been made the MA would need to be transferred to the new MAH. If we consider this statement from another perspective, perhaps the MHRA or VMD, may take the decision to request a MAH that is established in the UK.

Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc. (1).  If a MAH has a UK based Batch Release or Batch Testing site for a product marketed in the EU, come March 2019, the MAH would need to elect EU based sites to prevent interruption of supply.  Once established the MAH would need to file Variations for each MA to change the site, as well as meet the requirements of the Health Authority in order for the Variation to be approved.  In case a MAH elects a UK based EU Qualified Person for Pharmacovigilance (QPPV) or has a UK based Pharmacovigilance System, the MAH would need to move these activities to the EU in order for the Pharmacovigilance of a product to be maintained, and patient safety ensured.

We hope this post brings further awareness of the implications of the Article 50 of the Treaty of the European Union, and we invite you to share your opinion regarding the impact on MAH’s with products registered in the UK and EU.

BrexitCP submissions EMA MAH MRP/DCP Regulatory Affairs eCTD

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