EMA: Update of the Q&As on the Topic of "Parallel Distribution"

Once again, the "Frequently asked questions about parallel distribution" have been revised and published on the EMA website. The information provided by the EMA on the parallel distribution of centrally authorised medicinal products is set out in six paragraphs in the catalogue of questions and answers:

  • General 
  • Initial notification 
  • Parallel distribution notification check 
  • Post - Parallel distribution notice guidance 
  • Safety updates/bulk changes/annual update 
  • Fees

In the latest version, the following question has been updated in the first paragraph "General":

  • 1.2.  What are the procedures of parallel distribution?

In paragraph 2, the following question and its answer have been revised:

  • 2.7 Where to find the latest published annex/EU marketing authorization?

In the fifth paragraph "Safety updates/bulk changes/annual update", question 5 and its answer have been updated:

  • 05. What is an annual update?

Question 5.10 "What are the requirements for dormant notices?" has been added. The three other sections have not been revised.

Please see the updates and the complete list of answers to the "Frequently asked questions about parallel distribution" on the EMA website.

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