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