Europe – Duplicate marketing authorisations for biological medicinal products

This point was presented in the Pharmaceutical Committee meeting of October 2018. The
purpose of this document is to inform Member States of the results of the targeted
Stakeholder consultation2 which took place from 18 May to 10 September 2018 and to
exchange views on the possible revision of the Commission note on the handling of
duplicate marketing authorisation applications.

1. Background

In the framework of the centralised procedure, only one marketing authorisation may be
granted to an applicant for a specific medicinal product. In view of the unique nature
and EU dimension of marketing authorisations granted under the centralised procedure,
Regulation (EC) 726/2004 limits the ability of applicants/holders to obtain more than one
marketing authorisation per medicinal product.

In particular, Article 82(1) 2nd subparagraph of Regulation (EC) 726/2004 provides that:

« the Commission shall authorise the same applicant to submit more than one
application to the Agency for that medicinal product when there are objective
verifiable reasons relating to public health regarding the availability of medicinal
products to health-care professionals and/or patients, or for co-marketing
reasons. »…