Apr 15 2021

Withdrawal Agreement Medicines

Published by at 11:18 pm under Uncategorized

The meeting, which will take place on Friday, February 1, will focus on human and veterinary medicine as well as medical devices and will include brief speaker presentations, followed by an open forum to allow questions, identify areas of concern and exchange information. Our main objective is to ensure the protection of human and animal health by facilitating access to medicines in the absence of an agreement. If the UK withdraws in the absence of a withdrawal agreement or agreement (“non-agreement scenario”), EU legislation will no longer apply to the UK. In this case, companies operating in the UK must make changes in order to continue to supply medicines in the EU in order to comply with EU law. The life sciences sector is one of the most regulated and harmonized industrial sectors in the world. Much of the regulation comes from the EU in the form of directives or regulations and is supplemented by guidelines from the European Commission and the European Medicines Agency (EMA), the EU`s decentralised agency responsible for scientific assessment, monitoring and monitoring of drug safety in the EU. Communication to stakeholders – Withdrawal of UK and EU provisions on human and veterinary medicines The Commission also states in this statement that the MAH must identify, by 29 March 2019, a batch release post in the EU-27 to ensure compliance with EU legislation after withdrawal. Businesses are reminded that from 30 March 2019, the MAH must be established in the EU and that all remaining immemorial transfers must be submitted as a matter of urgency so that treatment is possible up to the withdrawal date. The impact of Brexit on the pharmaceutical industry, particularly the interruption of drug supplies, has been a central theme of the negotiation process. The next step in the draft agreement is approval by the British Parliament; this is expected in the coming days. Companies have until 31 December 2020 to make the necessary changes to ensure that their authorised medicines comply with EU law and can remain on the EU market. Licensees/applicants for marketing authorisation may continue to be established in the UK and qualified for pharmacovigilance (QPPVs) and pharmacovigilance system management files (PSMF) and quality test/exit sites can still be installed in the UK until the end of 2020.

Although not directly linked to the pharmaceutical industry, the agreement of a transitional period and its objectives will affect all UK industries. EU legislation based on the authorisation of life sciences products and exclusive rights – in particular the authorisation and monitoring of the market for medicines, data and market exclusivity, supplementary certificates of protection, protection of orphan medicines and CE marking – will also apply in the UK during the transitional period. For more information on human and veterinary medicines, visit the news section of our website. On 14 November, the UK government published its draft agreement on the UK`s withdrawal from the European Union (EU), scheduled for 29 March 2019. If you have any procedural or regulatory questions regarding Type I variants for drugs for human use, please contact iaquery@ema.europa.eu or ibquery@ema.europa.eu.


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