Spain simplifies MA variation procedure for medicinal products

With an informative note dated 20 April 2017, the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) introduced measures to speed up the procedure for granting variations to the marketing authorisation (MA) of medicinal products.

Under the former procedure, the grant of an MA variation authorisation required in certain cases (i) the confirmation or modification by the MA holder and (ii) the review and validation by the AEMPS of all administrative data before the MA variation could be granted.

With the introduction of the revised procedure, which became effective on 24 April 2017, the AEMPS will first issue a valid decision on the MA variation, and only afterwards will proceed to the review and implementation of any changes in the administrative data in the existing database RAEFAR.  All AEMPS decisions on MA variations will continue to contain a link to the updated SmPC, PL and labelling, but they will no longer refer to the administrative data.  This data will be separately accessible through RAEFAR with an indication of the date of update and a reference to the MA variation through which the data was introduced.

The AEMPS expects that the revision will reduce delays in the MA variation procedure and will also limit the number of errors in the processing of applications – two shortcomings related to the complex procedure deriving from the introduction of the electronic Application Form in 2016.

This post was originally co-authored by Marco de Morpurgo & Patricia Carmona Botana.