EMA publishes a report on the impact of Brexit on the authorization of medicines
Source: actasanitaria.com
A day after knowing the draft agreement on Brexit that last Tuesday, November 13, reached the European Union (EU) and the British Government, the European Medicines Agency (EMA) has published a report on the meeting of 24 September 2018 that was held with industry stakeholders to discuss the departure of the UK from the EU and the impact it will have on the operation of the centralized procedure for the authorization of veterinary and human drugs.
The published document describes how the regulatory network of medicines in Europe for Brexit is being prepared, including the relocation of the Agency itself and the planning of business continuity.
At the meeting, the participants received updated information about the EMA plans for Brexit preparation, “that guarantee that all basic activities related to the evaluation and supervision of medicines continue without interruption, and with the same quality and deadlines during the relocation of the Agency in Amsterdam and throughout 2019, “explains this agency.
The EMA entered phase 3 of its commercial continuity plan for Brexit preparation on October 1, 2018, with the suspension or temporary reduction of some additional activities, “including the reduction of the development and revision of guidelines, and the temporary suspension of work groups not related to the product “. These steps were taken to ensure that the Agency can focus on its core business of protecting human and animal health and that the released resources can be redistributed to allow the entity to protect its core activities related to the evaluation and monitoring of medicines.
Variation requests
The meeting was organized by the EMA together with the European Commission and was attended by a wide range of industry stakeholders. Participants were again encouraged to submit all variation requests related to Brexit before the end of 2018 to ensure that their marketing authorizations comply with EU pharmaceutical legislation before leaving the UK.
Distefar echoes this publication
