EMA: Q&As on the Topic of "Parallel Distribution" updated

Recommendation

20/21 February 2024
Munich, Germany

GMP meets Regulatory Affairs
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

Again, the "Frequently asked questions about parallel distribution" were revised and published on the EMA website. The information provided by the EMA on parallel distribution of centrally authorised medicinal products is set out in the Q&A in six paragraphs:

• General 
• Initial notification 
• Parallel distribution notification check 
• Post - Parallel distribution notice guidance 
• Safety updates/bulk changes/annual update 
• Fees

In the latest version, the following question has been added to the first section "General":

• 07.  What to do when my organisation details have changed?

In the fifth paragraph "Safety updates/bulk changes/annual update", questions 4 and 5 and their answers have been updated:

• 04. How to submit a bulk change? 
• 05. What is an annual update?

The four other sections remain unchanged.

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