The new, extended, scheme will begin before the existing European scheme expires.Īnnouncing the new approvals system in a statement on, the MHRA said the recognition routes had been facilitated by existing international partnerships, such as those developed through the Access Consortium and Project Orbis. EMA decisions have continued to apply in Northern Ireland. The fast-track mechanism to GB approval was intended to last for two years after Brexit, but was extended in January 2023 for another year. Since the UK left the European Union in January 2020, the MHRA’s European Commission Decision Reliance Procedure has allowed companies to apply immediately for a marketing authorisation in Great Britain on receipt of a positive opinion from the EMA’s Committee for Medicinal Products for Human Use. Medicines approved by regulators in Australia, Canada, Japan, Switzerland, Singapore and the United States will be added to those given marketing authority in Europe by the European Medicines Agency (EMA), making them eligible for the faster MHRA approval route. New recognition routes for drugs approved outside the UK will come into place in the first three months of 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) has said. Journal of Pharmaceutical Health Services Research. International Journal of Pharmacy Practice.Antimicrobial resistance and stewardship.
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