News about GMP/cGMP

27.03.2020

Updated version 17 of the Q&A on safety features for medicinal products for human use

On March 9, 2020, the European Commission published version 17 of the Q&A on safety features for medicinal products. The document is updated on a regular basis (we reported).

Question 5.11 is new:

  • Q&A 5.11 clarifies whether wholesalers should be connected to the national repositories  or to the European hub. Wholesalers physically holding products or performing activities according to the Articles 20–23 of the Commission Delegated Regulation (EU) 2016/161 should be connected to the national repository where the acitivities take place.

Question 1.22 received additions:

  • Q&A 1.22 deals with the handling of safety features by parallel traders. If a new, equivalent safety feature is placed by parallel traders, it should meet the requirements of the Member State in which the medicinal product is intended to be placed on the market. Centrally authorised products from which parallel traders remove or cover safety features are expected to display the original manufacturer's batch number. Traceability in the repository must be maintained in all cases.

Source:

European Commission: Safety Features for Medicinal Products for Human Use



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