La Commissione Europea detta nuove regole per il controllo di qualità dei medicinali in vista della Brexit

The process of coordination of the European-regulated procedures to the Brexit event is unceasingly going on.

With reference to the pharmaceutical sector, in 2018 the EMA (European Medicines Agency) has already provided some indications to stakeholders on the methods for facing the withdrawal of the United Kingdom pursuant to art. 50 of the Treaty on European Union. Every indication published so far is characterized by the presence of an identical thread: the UK will become a Third State and companies based in the UK will have to move to the EU in order to benefit from the application of the European common rules.

In this regard, on 25 February the European Commission notified the competent authorities of the 27 Member States and the European Medicines Agency with the transitional rules on quality controls for the marketing of medicinal products following Brexit, published by the Italian Ministry of Health on 27 February.

The European Commission points out, as a preliminary step, that the pharmaceutical industry is already aware of the need to adapt its processes to the new scenario and to consider the possibility that the terms for the issuance of marketing authorizations may be subject derogations, due to the circumstances of the moment.

The communication of 25 February therefore focuses  on the quality controls to which each batch of medicine must be subject if the medicinal products come from Third Countries (in compliance with the provisions of art. 51 (1) (b) of Directive 2001/83/EC) and concludes by stating the necessity for each batch currently located in the United Kingdom to undergo a qualitative analysis within the EU territory, before 30 March 2019.

In fact, the aforementioned rule (art. 51 (1) (b)) provides that in the case of medicinal products coming from third countries, each production batch shall undergo, in the importing Member State, a full qualitative analysis, a quantitative analysis of at least all the active constituents and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorization.

However, such an approach could be excessively burdensome for pharmaceutical companies.

With the aim of providing rules that can simplify the fulfillment of the stakeholders’ duties and, at the same time, do not hinder the supply of medicines on EU territory, the Commission refers to art. 20 (b) of Directive 2001/83/EC pursuant to which the competent authorities may authorize manufacturers and importers of medicinal products from third countries, in exceptional and justified cases, to have certain stages of manufacturing and/or some of the controls carried out by third parties.

Therefore, in order to be able to apply the procedure pursuant to art. 20 (b), the Commission invites pharmaceutical companies to send a communication to the competent national authority by 29 March, in which the MA holder must:

• specify the batch release site in the EU27;
• confirm that the qualified person established in the EU27 is responsible for the quality control testing site in the United Kingdom;

• confirm and set out their precise timetable for transfer of the quality control testing site (which should allow the process to be completed quickly and in principle by the end of 2019 at the latest);

• specify the period of time and batches (packs and quantities) that are requested to be exempted. This should be strictly restricted to what is necessary;

• transfer samples of those tested batches together with the testing results to the batch release site in the EU27 in due time to make them available for inspection;

The communication must be sent to the competent national authority that will proceed to evaluate, on a case by case basis, whether or not to issue the relative authorization.

The Commission concludes by stating that, if the exemption pursuant to art. 20 (b) is not applicable, medicinal products produced in the United Kingdom cannot be imported into the EU until they have carried out the controls required for importation from any other Third Country.

The note shall be intended without prejudice to the possibility that an EU-UK agreement aimed at regulating the new dynamics of the pharmaceutical market may be concluded.