Update of the EMA Q&As on parallel Distribution of Medicinal Products

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)

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.

"General"

In the first section, "General", the following four questions and answers have been updated and supplemented:

• 3.   Are the Agency parallel distribution notification procedures mandatory? 
• 8.   What are the post-PD notice obligations of a parallel distributor? 
• 16. Does the 'specific mechanism' apply to parallel distributors? 
• 22. Can the PD notice be transferred?

"Initial notification"

In the second paragraph "Initial notification", updates have been made to the answer to the question "3. How to apply for the PD notice?".

"Parallel distribution notification check"

The third paragraph "Parallel distribution notification check" includes revisions to the following three topics:

• 11. Can several languages be combined in one pack? 
• 16. How many manufacturers are allowed in the package leaflet and on the outer labelling? 
• 17. What are the requirements for the 'blue box'?

"Post- Parallel distribution notice guidance"

In the fourth section "Post- Parallel distribution notice guidance" the answers to the following questions have been adapted:

• 3. Can the Agency request the national competent authorities to perform an inspection of a parallel distributor? 
• 4. What are the parallel distributors' responsibilities regarding quality defects?

"Safety updates/bulk changes/annual update"

The fifth paragraph "Safety updates/bulk changes/annual update" contains updates on the following two points:

• 2.   How to submit a safety update? 
• 10. How to submit an annual update?

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.