6/7 September 2022
A new version of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was prepared in December 2021 and published on the HMA (Heads of Medicines Agencies) website. General topics regarding the variation procedures and their submissions for human medicinal products are listed and answered.
The new version of the question and answer catalogue now only refers to medicinal products for human use, so that all previous references and information about veterinary medicinal products are no longer present in this version or have been deleted. As a result, almost all chapters of the document have been revised and thus almost all sections contain changes, which are clearly highlighted by track changes in the text and are thus easy to follow in the new version.
Similarly, updates have been made due to the new developments in the area of "electronic submission". These include, for example, the following questions and sections:
Here you can find both versions of the new "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" - with and without track changes.