EMA: Another Update of the Q&As on Parallel Distribution

Recommendation

6/7 September 2023
Vienna, Austria

Drug Master File Procedures in the EU, the US and Japan
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

Already in April 2022, the "Frequently asked questions about parallel distribution" were revised and published on the EMA website. You could arelady read about the updates contained therein under "Update of the EMA Q&As on parallel Distribution of Medicinal Products". Now, the Q&As have been updated again and supplemented.

The information provided by the EMA on parallel distribution of centrally authorised medicinal products is set out in the Q&As over six paragraphs.
 
In the new version from May 2022, the first section "General" presents the update of the following question:

• 16. Does the 'specific mechanism' apply to parallel distribution?

The second paragraph, "Initial notification", includes a new question 9 and its answer:

• 9. What are some examples of grounds for invalidation, negative outcome and common mistakes often made?

Similarly, the third point "Parallel distribution notification check" contains a new question followed by its answer:

• 20. Do parallel distributors have to adhere to particular packaging design or/and colour code when repackaging the products?

The subsequent three sections have not been revised.

The updates and the full list of answers to the "Frequently asked questions about parallel distribution" can be found on the EMA website.