EMEA UPDATES POST-AUTHORIZATION GUIDANCE

The European Medicines Agency (EMEA) has released an updated post-authorization guidance. The update addresses recent changes regarding marketing and cessation notification requirements and the sunset clause.

Marketing and cessation requirements involve informing the agency when a product is placed on or taken off of the market. The sunset clause is a provision that revokes marketing authorization if a product is not placed on the market within three years of authorization being granted or if a product previously placed on the market is no longer actually present on the market for three years.

This guidance document addresses a number of questions marketing authorization holders may have on these procedures. It will be updated regularly to reflect new developments, to include guidance on further post-authorization procedures and to reflect the implementation of new legislation.

The guidance website includes a list of questions to answer most queries, and the EMEA encourages companies to contact the agency with other questions in advance of any post-authorization submissions. The guidance can be viewed at www.emea.eu.int/htms/human/postguidance/index.htm.