The EU view of the Windsor Framework
- Mar 8, 2023
- 1 min read
The EU text on the new plan for medicines supply to Northern Ireland has a few interesting additional points that aren't covered by the UK published documents.
1 -Packs bearing the Unique Identifier safety feature shall be fully removed or covered.
2 - Medicines for NI shall bear an individual label which shall comply with the following conditions:
(a) it shall be attached to the packaging of the medicinal product in a conspicuous place in such a way as to be easily visible, clearly legible, and indelible; it shall not be in any way be hidden, obscured, detracted from, or interrupted by any other written or pictorial matter or any other intervening material.
(b) it shall state the following words: ‘UK only’
3 - UK only medicinal products shall not be moved from Northern Ireland to a Member State or be placed on the market in a Member State.
4 - MHRA shall continuously monitor the placing into the market in Northern Ireland of medicinal products and the effective enforcement of the specific rules.
5 -Medicinal products that have been lawfully placed on the market in Northern Ireland before the date of this new Regulation, and that are not repackaged or relabelled after that date, may be further made available on the market in Northern Ireland until their expiry date without being required to comply with the specific rules laid down above.
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