Medicinal products

Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products

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

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.

How to submit your contribution

Stakeholders are invited to comment on this consultation by 10 September 2018 at the latest. Responses should preferably be sent to sante-pharmaceuticals-B5@ec.europa.eu

They can also be sent by post to Directorate-General for Health and Food Safety, Unit SANTE B/5, BE-1049 Brussels. The subject line of the letter or email should contain the reference "Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products".

When submitting your response, please include your name and e-mail address and specify if you are responding as an individual or as a representative of an organisation. If you represent an organisation, please indicate its name and category (company/business; public authority (local, regional, national, international); patient organisation; healthcare professional organisation; academic; NGO; other).

If you represent a company, please state whether it falls within the EU definition of a small and medium-sized enterprise (i.e. less than €50 million annual turnover and fewer than 250 employees).

If your organisation is registered in the Transparency Register, please indicate your Register ID number at the beginning of your contribution.

The consultation document

The consultation document can be downloaded here

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.