The transition period in the relationship between the European Union (EU) and the United Kingdom is due to end on 31 December 2020. Henceforth, EU legal acts prohibiting or restricting import and export of active substances, medical devices, products of human origin will be applicable to the United Kingdom as to any other third country.
Qualified persons responsible for pharmacovigilance will have to conduct business in the EU. All clinical trials authorised in the EU will require a sponsor or legal representative conducting business in the EU.
Companies currently distributing medicines and medical devices manufactured in the United Kingdom will become importers and will be subject to the duties and responsibilities of importers laid down in the normative acts.
Please note that marketing authorisation holders of authorised medicines are responsible for making amendments to marketing authorisation documentation until 31 December 2020 to ensure compliance of the relevant medicinal product documentation with EU requirements. Further information is available here: https://www.hma.eu/535.html
Starting from 1 January 2021, the procedure for import of medicines from the United Kingdom will be governed by the Cabinet Regulation No. 436 of 26 June 2007 “Procedures for the Importation and Exportation of Medicinal Products”.
Merchants (for example, medicinal product wholesalers) planning on importing medicines into Latvia from a third country will require a special permit (licence) issued by the State Agency of Medicines for manufacturing or import with an authorised activity of medicinal product import (not applicable to unauthorised medicines, medicinal product samples and transit). This includes the requirement to ensure quality control of the relevant batch of medicines in an appropriately authorised EU laboratory and certification for release on the EU market for distribution.
With regard to medical devices, certificates issued by the United Kingdom for release of devices on the EU market will no longer be valid and certification of medical devices will be performed by notified bodies conducting business in the EU. Upon releasing medical devices on the EU market in their own name, manufacturers with a business registered in the United Kingdom will have to assign an authorised representative in the EU with a business registered in an EU member state. Third country manufacturers with an authorised representative in the EU whose business is registered in the United Kingdom will have to relocate their authorised representative to the EU or assign a new authorised representative conducting business in the EU.
Medicines intended for research purposes may be imported by a person whose special permit (licence) for medicinal product manufacturing/import indicates that import of investigational medicinal products is permitted.
Additional information regarding receipt of the relevant licence is available on the Agency’s website: https://www.zva.gov.lv/lv/industrijai/zalu-razotaji/zalu-importetajs
Please note that, starting from 1 January 2020, EU legal acts regarding recognition of professional qualification will no longer be applicable to the United Kingdom. Therefore, citizens of the United Kingdom, regardless of where they have obtained their pharmaceutic qualification, and EU citizens, who have obtained their pharmaceutic qualification in the United Kingdom, will have to pursue official recognition of their qualification in the relevant member state, based on the regulations regarding recognition of qualifications from third countries in effect in that member state. Information regarding the process of diploma recognition is available on the website of the Academic Information Centre: http://www.aic.lv/portal/arvalstu-diplomu-atzisana.
Please note that these changes also affect the regulatory field of substances of human origin (blood, tissues and cells, organs). Further information is available here: https://ec.europa.eu/info/sites/info/files/brexit_files/info_site/substances_of_human_origin_en.pdf