The EMA has issued Questions and Answers to Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use.
The document is intended to give practical guidance on the applicable rules to centrally authorised medicinal products for human use intended to be placed on the market in Northern Ireland before and after the application of Regulation (EU) 2023/1182.
See here for ‘Questions and Answers’ document and here for ‘Legal Content’ link
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