In April 2022, the EMA (European Medicines Agency) supplemented or revised its 30-page Q&A on frequently asked questions on parallel distribution with further Q&As. The new Q&As are marked by date (April 2022).
Which questions are new or updated?
General
- Are the Agency parallel distribution notification procedures mandatory? (3)
- What are the post-PD notice obligations of a parallel distributor? (8)
- Does the 'specific mechanism' apply to parallel distributors? (16)
- Can the PD notice be transferred? (22)
Initial notification
- How to apply for the PD notice? (3)
Parallel distribution notification check
- Can several languages be combined in one pack? (11)
- How many manufacturers are allowed in the package leaflet and on the outer labelling? (16)
- What are the requirements for the “blue box”? (17)
Post- Parallel distribution notice guidance
- Can the Agency request the national competent authorities to perform an inspection of a parallel distributor? (3)
- What are the parallel distributors' responsibilities regarding quality defects? (4)
Safety updates/bulk changes/annual update
- How to submit a safety update?
- How to submit an annual update?
Source:
EMA: Webseite zu Parallelvertrieb