Article 22 of Commission Delegated Regulation (EU) 2016/161 has been amended by the European Commission. As a result, it is no longer be required to decommission packs - in accordance with Article 22 - when such packs are exported from the EU to Great Britain.
EMVO strongly recommends OBPs to upload into the UKNI system all serialised packs that are physically placed on the market in any part of the United Kingdom. This is important as the small markets, Malta, Cyprus and Ireland, rely on medicinal supply from the United Kingdom.
The import of such non-decommissioned packs to the EU (via Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland) will be possible provided that:
the wholesale distributor or the marketing authorisation holder established in the
EU and responsible for the export of the medicinal product to the United Kingdom
has verified the pack against the EMVS;the wholesale distributor importing the product into Northern Ireland, Ireland,
Cyprus or Malta has verified the pack against the EMVS.
For more information, please see The European Commission’s 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 published on 22nd December 2020.