EU Commission publishes a New Document about Duplicate Marketing Authorisation Applications

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:

  • For reasons that concerns public health regarding the availability of medicinal products
  • For co-marketing reasons

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:

  • Case-by-case decision - the decision about the submission of several authorisations must be done case-by-case.
  • Precise definition of the elements under the scope of Article 82(1)
  • Public health aspects

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:

  • The active substance is a different salt.
  • The pharmaceutical form contains alternative excipients.
  • The product is manufactured at a different site or by another manufacturer.
  • Different data but same composition in active substances and galenic form
  • A duplicate application may contain fewer indications or pharmaceutical forms than the original one when this is necessary to market the product in Member State where a specific indication or pharmaceutical form is protected by patent law. However, the applicant shall be obliged to withdraw the marketing authorisation with restricted indications/pharmaceutical forms after the relevant patents are no longer in force.

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.

Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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