News about GMP/cGMP

09.04.2021

Export to UK: Exemption for Wholesalers

Export to UK: Exemption for Wholesalers

The European Union has published the Delegated Regulation (EU) 2021/457 in its Official Journal on 17 March 2021. It amends the Delegated Regulation (VO) 2016/161 on safety features necessary for the packaging of medicinal products for human use. The amendment is to exempt the obligation for wholesalers to deactivate the unique identifier of medicinal products exported to the United Kingdom, being considered a third country now.


What's behind this?

The intent is to ensure that medicinal products with unique identifiers can be distributed to the small markets depending on the UK for their pharmaceutical supplies. The exemption lifts the requirement for wholesalers to deactivate the unique identifier of products they wish to distribute in the UK, as these could be re-exported to the Union, which is to say, to the small markets. These include Cyprus, Malta, Ireland or Northern Ireland, which are supplied through Great Britain.

There are currently no importers in these small markets holding a manufacturing authorisation and are therefore able to meet the obligation to affix a new unique identifier under Union law as of  January 1, 2021. This circumstance makes it virtually impossible to comply with the mentioned obligation. The exemption thus ensures that no medicinal products without safety features can enter the Union market.

The exception will be applicable from January 1, 2021 to December 31, 2021. The information can be found in Article 1 of Commission Delegated Regulation (EU) 2021/457.


Source:

EC: Commission Delegated Regulation (EU) 2021/457


 

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