On 22nd December 2020, the European Commission, with its Notice C (2020) 9264 on the Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period confirms that the placing of safety features foreseen in the Falsified Medicines Directive will be required for medicinal products placed in Northern Ireland, but not for products placed in any other part of the United Kingdom. According to the Notice, as of 1st January 2021, packs destined for Great Britain should be separated from packs destined for Cyprus, Ireland, Malta or Northern Ireland – even where the supply route goes through Great Britain. This means that manufacturers and marketing authorisation holders will need to ensure the upload of the required data in the EMVS for Cypriot, Irish, Maltese and Northern Irish packs but not for packs with a final destination in any other part of the United Kingdom (Great Britain).
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Written by Tracy Slosse
Updated over 2 years ago