The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CmDH) has released an updated Variations Q&A document containing some revisions to previous questions and answers and some entirely new ones.
Generally the updates relate to added information in the answers to the questions to cover veterinary medicinal products as well. However there are also some new questions that have been added and a deletion.
Question 1.8 has been added and relates to how the applicant should submit changes to the Product Information after an administrative renewal following a repeat-use procedure that involves only some of the Concerned Member States.
Question 3.28 is also new and covers the topic of how to remove one approved API manufacturer where the CEP is part of an approved dossier.
Question 4.20 has been added under the questions relating to grouping or worksharing, and clarifies that where a new or updated CEP is submitted and condition 2 under variation category B.III.1.a is not met, the additional impurity is the reason for the upgrade to the Type IB variation and therefore can be assessed under the same variation as the CEP.
Finally, Question 2.11.a, “How can I update my product information according to the requirements of the pharmacovigilance legislation with regard to the implementation of the black symbol and the explanatory statements on additional monitoring and adverse drug reactions reporting?” has been deleted. Presumably this is because the requirement for companies to submit the variation implementing the black symbol/additional monitoring and ADR reporting was by 31st December 2013 and the assumption is now that all companies have complied. Therefore, because this is now part of the QRD template this question will no longer arise.
The CmDH document containing the tracked changes can be found here.