EMA: Updated Q&A on Parallel Distribution
Centrally authorised medicinal products placed on the market in one European Member State may be marketed under the same name in any other Member State by a distributor independent of the marketing authorisation holder. This process of parallel distribution is supervised by the EMA.
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:
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