Track & Trace: Amendment of the Delegated Regulation on Safety Features

Recommendation

6/7 June 2023

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On 17 March 2021, the Delegated Regulation (EU) 2021/457 was published in the Official Journal of the European Union. It amends the Delegated Regulation 2016/161 regarding an exemption from the obligation for wholesalers to decommission the unique identifier (UI) of medicinal products exported to the UK.

Export to UK: temporary derogation for wholesalers to decommission the UI

By way of derogation from Delegated Regulation 2016/161, the following applies:

• The obligation to decommission the UI for medicinal products that the wholesaler intends to distribute outside the Union will not apply from 1 January 2021 to 31 December 2021 for medicinal products intended for distribution in the UK.
• Packages do not have to be decommissioned until 31 December 2021 if these packages are exported from the EU to the UK. This will apply retrospectively from 1 January 2021.

As a number of medicinal products are supplied to Cyprus, Ireland, Malta or Northern Ireland via the UK, it would be the importers' responsibility to apply a new UI to the medicinal products, if the packages had to be decommissioned accordingly. However, there are currently no importers in Cyprus, Ireland, Malta and Northern Ireland with a manufacturing authorisation who could fulfil this obligation from 1 January 2021. Therefore, according to the EU Commission, it is necessary to grant a temporary derogation from the obligation to decommission the UI of medicinal products distributed in the UK.

The Delegated Regulation (EU) 2021/457 can be found in the Official Journal of the European Union.