News about GMP/cGMP

06.05.2022

EMA: Updated Q&A on Parallel Distribution

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:

EMA: Webseite zu Parallelvertrieb


 

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