New revision of the template for Risk Management Plan

Monday, August 07, 2017

On the 30th of March 2017, EMA published the second revision of the RMP template, which marketing authorisation holders and applicants can use for all RMP submission as of 31 March 2017. The second revision becomes mandatory for all RMP submissions as of 31 March 2018.

In July CMDh decided that for DCP and MRP marketing authorisation holders and applicants may still use the first revision of the template (rev. 1):

  • throughout the initial DCP, for marketing authorisation applications submitted until 30 September 2017
  • until 30 March 2018 for all other applications submitted via MRP (including applications for a new Marketing Authorisation via MRP/RUP)

For the national procedure the Medical Products Agency has decided that marketing authorisation holders and applicants may still use the first revision of the template (rev. 1):

  • throughout the initial application, for marketing authorisation applications submitted until 30 September 2017
  • until 30 March 2018 for all other applications

For centrally approved products, please see information published on the EMA web site; please find link in the right column.

 

Please note the news item’s date of publishing. The Medical Products Agency does not update news.

 

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