Лекарствени продукти за хуманна употреба

Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products

  1. Български
  2. English

Targeted stakeholders

All stakeholders involved in the development, manufacture and/or commercialisation of medicinal products for human use, in particular biological medicinal products and biosimilars, patient groups, healthcare professionals, as well as insurance and procurement agencies.

Period of consultation

18 May - 10 September 2018

This consultation is now closed.

Objective of the consultation

Since the publication of the note on the handling of duplicate marketing authorisations in 2011, the Commission Services have identified potential issues related to the granting of duplicate marketing authorisations for biological medicinal products on the ground that they would be a "first generic". These issues relate to the possible impact of such duplicate marketing authorisations on the biosimilar market (including potential anticompetitive effects) and the undermining of treatment options available to patients.

The objective of the targeted stakeholder consultation is to seek the views of interested parties on the specific issue of the impact of duplicate marketing authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients. The results of the targeted stakeholders consultation will allow the Commission to take an informed decision as to whether there is a need to clarify the current wording of Annex I, Section 1 of the note on the handling of duplicate marketing authorisations applications on this particular matter.

In the interim, requests for duplicate marketing authorisation applications in this specific case will be assessed on a case-by-case on the basis of the evidence provided by the applicant.

Contact details

Any queries about the targeted stakeholder consultation should be sent to: Unit B5 - Medicines: policy, authorisation and monitoring, Directorate-General for Health and Food Safety. at sante-pharmaceuticals-B5@ec.europa.eu

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Specific privacy statement

Received contributions and/or a summary report will be published online. It is important to read the specific privacy statement attached to this consultation for information on how your personal data and contribution will be dealt with.