Notification of Request for Exemption to Continue Medicinal Product Batch Control Testing in the United Kingdom (UK) after Brexit

SÚKL hereby informs marketing authorisation holders on cases of notification of request for a time-limited exemption to continue medicinal product batch control testing in the UK for medicinal products authorised via the MRP/DCP.  

In compliance with European Commission´s guidance https://ec.europa.eu/health/sites/health/files/files/documents/brexit_batchtesting_medicinalproducts_en.pdf of 20 February 2019, the CMDh Coordination Group issued guidance regarding notification of requests for exemption to continue medicinal product batch control testing in the UK for medicinal products authorised via the MRP/DCP also after Brexit (question and answer no. 32 presented here: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_373_2018_Rev3_2019_02_clean_-_Practical_guidance_for_Brexit.pdf).

This request is available from the CMDh website (http://www.hma.eu/535.html) as Template for Notification of request for a time-limited exemption to continue batch control testing in the United Kingdom (UK) after UK’s withdrawal from the Union for a nationally authorised medicinal product.

The request is preconditioned by batch release being conducted by an authorised manufacturer within the EEA territory (outside the UK) and by the request being sent prior to 29 March 2019 to the contacts specified at: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_393_2019_Rev0_2019_02_3_-_Contact_points_exemption_for_batch_control_sites.pdf.

Where medicinal products authorised in the Czech Republic via the national procedure are concerned, it will not be necessary to submit this request, as long as the Act Governing Some Relations with Regard to the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union (so called “Lex Brexit” available from: http://www.psp.cz/sqw/text/tiskt.sqw?O=8&CT=368&CT1=0), Section 26 of which sets forth the conditions for the handling of medicinal products manufactured or released in the United Kingdom, is in effect as of the date of the UK´s withdrawal from the European Union.

In cases where the Czech Republic acts as the Reference Member State (RMS) in respect of a product authorised via the MRP/DCP, such request has to be sent to SÚKL regardless of the effect of “Lex Brexit”, because the Czech Republic as the RMS shall be granting the exemption for all Concerned Member States (CMS) in the procedure. In such a case, the request is to be sent to mrp@sukl_cz, cc all CMS.

In cases where the Czech Republic acts as the Concerned Member State (CMS) in respect of a product authorised via the MRP/DCP, such request is to be sent to the RMS, but even in case the RMS does not grant the exemption, “Lex Brexit” shall be effective for the territory of the Czech Republic.

With regard to the fact that “Lex Brexit” is legislation effective only within the territory of the Czech Republic, it is not possible to infer any effects of this Act in respect of other EU Member States or other marketing authorisations of medicinal products than those in the Czech Republic.

Marketing Authorisation Branch

8 March 2019