The Windsor Framework: Centralised Products and Northern Ireland

2024-01-30T09:18:27+00:00January 25th, 2024|

The EMA has recently published a Q&A guide on the implementation of Regulation (EU) 203/1182 and the potential need by Marketing Authorisation Holders to prepare in advance any regulatory, labelling and/or supply changes required for its implementation to help ensure the continuous supply of the product.

The Windsor Framework: UK Licensing Guidance

2024-01-22T13:52:03+00:00October 19th, 2023|

The MHRA issued new UK-wide licensing guidance on 29th September 2023. This provides information on how licensing changes will be implemented when the Windsor Framework takes effect on 1st January 2025. Regulatory Team Leader Nicola Gover captures the key findings from the guidance to help clients with existing or planned UK, GB or NI licences understand their next steps.

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