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18 May 2022

EMA updates Questions & Answers on Parallel Distribution

Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing authorisation holder. Centrally authorised products are marketed in all Member States under the same name and must comply with the Community Marketing Authorisation. The task of the European Medicines Agency (EMA) is to check compliance of products distributed in parallel with the conditions laid down in Community legislation on medicinal products and in the marketing authorisation of the product.

In July 2021 the European Medicines Agency (EMA) published a document entitled “Frequently asked questions about parallel distribution” (EMA/297155/2021). The document answers the most common questions on parallel distribution of centrally authorised medicinal products, is clearly laid out and divided into the following sections: General information, Initial notification, Parallel distribution notification check, Post-parallel distribution notice guidance, Safety Updates / bulk changes / annual update and, Fees.  In April 2022, the document has been supplemented, revised, and published on the EMA website. 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
    • what are the post-PD notice obligations of a parallel distributor
    • does the ‘specific mechanism’ apply to parallel distributors
    • can the PD notice be transferred
  • Initial notification
    • how to apply for the PD notice
  • Parallel distribution notification check
    • Can several languages be combined in one pack
    • how many manufacturers are allowed in the package leaflet and on the outer labelling
    • what are the requirements for the “blue box”
  • Post- Parallel distribution notice guidance
    • can the Agency request the national competent authorities to perform an inspection of a parallel distributor
    • what are the parallel distributors’ responsibilities regarding quality defects
  • Safety updates/bulk changes/annual update
    • how to submit a safety update
    • how to submit an annual update

The updates and the full list of answers to the Frequently asked questions about parallel distribution can be found on the EMA website.

Furthermore, the EMA has additional documents on parallel distribution published on their site in the section Parallel distribution: Regulatory and procedural guidance

  • List of centrally authorised products requiring a notification of a change for update of annexes
  • Checklist for initial notifications for parallel distribution: guidance for industry
  • Checklist for annual updates for parallel distribution: guidance for industry