News Category: Regulatory news
The European Commission has announced an extension until 31 December 2025 of the application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the UK. This allows companies and operators in Ireland, Northern Ireland, Cyprus and Malta to comply with EU law and prevent shortages of veterinary medicines, particularly on the island of Ireland.
The Commission had previously announced an extension until 31 December 2022. Marketing authorisation holders were expected to make necessary arrangements to comply with the EU legislation by that date. However, this has now been extended for a further final period until 31 December 2025.
Marketing authorisation holders that currently benefit from so-called ‘Brexit’ exemptions must engage with the national competent authorities to identify all relevant products. Later in 2023, the MAHs must provide a workplan charting how they plan to achieve full regulatory compliance with EU law within the timeframe given.