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

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.

Last updated: June 25, 2020
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