Im April 2022 hat die EMA (Europäische Arzneimittelagentur) ihr 30-seitiges Q&A zu häufig gestellten Fragen zum Parallelvertrieb mit weiteren Q&As ergänzt oder überarbeitet. Diese sind mit einem Datumshinweis (April 2022) versehen.

Welche Fragen sind neu oder überarbeitet?

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?

Quelle:

EMA: Webseite zu Parallelvertrieb