6/7 September 2023
The so-called "Frequently asked questions about parallel distribution" were updated in April 2022 and published on the EMA website. In July 2021 you could already read about the information provided by the EMA on parallel distribution of centrally authorised medicinal products, which has now been supplemented, revised and updated.
The question and answer catalogue comprises six paragraphs, only five of which are subject to adjustments.
In the first section, "General", the following four questions and answers have been updated and supplemented:
In the second paragraph "Initial notification", updates have been made to the answer to the question "3. How to apply for the PD notice?".
The third paragraph "Parallel distribution notification check" includes revisions to the following three topics:
In the fourth section "Post- Parallel distribution notice guidance" the answers to the following questions have been adapted:
The fifth paragraph "Safety updates/bulk changes/annual update" contains updates on the following two points:
The sixth section "Fees" was last revised in June 2021.
The updates and the full list of answers to the "Frequently asked questions about parallel distribution" can be found on the EMA website.