Changed procedure for nationally approved products in worksharing procedures where EMA is the reference authority

As of 1st of July 2020, MAHs will not receive approval letters for nationally approved products included in a worksharing, should the variation not affect the product information.

25.6.2020

In worksharing procedures, when one of the marketing authorisation is a centralised marketing authorisation, EMA is the reference authority. When products with national-, MR-, DC-marketing authorisation is also a part of this application, the changes are automatically approved by IMA at time of CHMP opinion.

As of 1st of July 2020, MAHs will not receive approval letters from IMA at the end of these worksharing procedures, when changes do not affect the product information. In cases where changes are made to the product information the applicants should submit updated texts to IMA at end of procedure.

Operating procedure for worksharing procedures, where a centralised marketing authorisation is not included, will remain unchanged. See further information in frequently asked questions (FAQs), question 9.

Back Send article