Track and Trace: What to do with Recalls?

When complying with the requirements of the Anti-Counterfeiting Directive and the Delegated Regulation (EU) 2016/161, the status message "recall" for recalled batches is of great relevance for the entire supply chain.

Track and trace systems: What to do in case of recalls?

The Delegated Regulation (EU) 2016/161 states that the marketing authorization holder has to ensure the decommissioning of the unique identifier (UI) of a medicinal product which is to be recalled or withdrawn, in every national or supranational repository serving the territory of the Member State or Member States in which the recall or the withdrawal is to take place.

In addition, the repositories shall contain an indication that the medicinal product has been recalled. This means that the pharmaceutical company, in accordance with GMP/GDP and the requirements of the Delegated Regulation, must carry out the decommissioning of the UI in advance of performing the actual recall. The medicinal product must be clearly identifiable as not-marketable and recalled for the entire supply chain. For this purpose, affected recall batches must be set to the status "recall" via the EU hub.

Further information on the implementation of the Anti-Counterfeiting Directive and the Delegated Regulation can also be found in the Q&A paper of the European Commission "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".