According to Article 82 of the EU Regulation No 726/2004 "only one authorisation may be granted to an applicant for a specific medicinal product". In exceptional cases though, the same applicant may submit more than just one application for that medicinal product:
On this matter, the EU Commission published a document in March 2010 which describes the approach for the dossier evaluation and the submission of several authorisations. On 6 October 2011, an update of this Guideline was published which contains following clarifications:
In the Guideline, you will find examples of cases where another authorisation application can be submitted for the same medicinal product under the fundamental condition that efficacy and safety of that medicinal product are not changed significantly:
Annex I of this Guideline explains the reasons for duplicate applications relating in public health matters. Only one reason is acceptable for duplicate applications, namely shortfalls in the availability of medicinal products which are mostly due to patent protection for one indication or galenic form in one or several countries. Co-marketing reasons are also acceptable for the application for a duplicate under the condition that the co-marketing partners are different entities, separate from the applicant.
For further information please see the EU Commission Guideline about duplicate marketing authorisation applications and the Regulation (EC) No 726/2004.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)