Version 18 of the Q&As on Safety Features for Track & Trace

The European Commission has published the 18th version of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".

News Q&As

Compared to the previous version 17, the new version contains four new questions and answers (Q&As) and three revised Q&As. 

  • As previously reported in the News entitled "Can the Application of Safety Features be outsourced?", the new Q&A 4.6 clarifies that the application of safety features can be outsourced to another manufacturer provided that the manufacturer has a manufacturing authorisation (MIA). It is important that a declaration in accordance with EU GMP Guidelines Annex 16 is made available to the responsible Qualified Person (QP) for the finished product. Q&A 2.14 was also supplemented for this purpose.
  • Q&A 5.12 discusses that it is not possible for wholesalers with multiple locations to use only one NMVO connection and one NMVO account for verification and decommissioning of medicinal products. Each location of the wholesaler must be uniquely identifiable when connecting to the NMVS and performing activities in the system.
  • Q&A 5.13 describes that a wholesaler who purchases medicinal products from another wholesaler who is neither the manufacturer, marketing authorisation holder or designated by the marketing authorisation holder, but receives the medicinal products directly from the manufacturer of the medicinal product, does not have to carry out a verification. 
  • Q&A 6.9 clarifies, by analogy with 5.12, that it is not sufficient for a pharmacy chain with multiple locations to link up via a single NMVO connection and a single NMVO account for the verification and decommissioning of medicines. Each location of a pharmacy chain has to connect to the NMVS for performing activities in the system.

Revised or supplemented Q&As

  • Q&A 1.8 describes how to deal with medicinal products used in "therapeutic trials" if there is no corresponding national regulation. According to the Q&A, the "importer" of a medicinal product brought into the territory of a Member State is not obliged to put safety features on the packaging or to upload safety features, if any, into the national repository of the new country of destination.
  • Q&A 2.14 stresses that the Delegated Regulation does not specify how and by which technology the safety features should be applied to the outer packaging. The responsibility regarding the application of the safety features on the packaging of a medicinal product lies with the QP. Any outsourcing of this activity to a third party by the manufacturer of the finished medicinal product must be in accordance with the principles described in Part I Chapter 7 of the EU GMP Guidelines (see also new Q&A 4.6).
  • Can packaging material with safety features be obtained from an external packaging supplier? In principle this is possible. Here, the addition to the answer to question 4.4 clarified the prerequisites for outsourcing (including checking the readability and correctness of the information in the data matrix code before release, existence of a signed delimitation of responsibility agreement, auditing and qualification of the supplier of the packaging material).

For more information please also read the 18th version of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".

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