Medicinal products for human use

Targeted stakeholder consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use

Targeted stakeholders

All stakeholders involved in the development, manufacture and/or commercialisation of medicinal products for human use, as well as patient groups, healthcare professionals and academia.

Period of consultation

From 27 February 2017 to 22 May 2017.

Objective of the consultation

According to Article 63(e) of Directive 2001/83/EC the Commission, in consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated. The original Guidelines on excipients in the labelling and package leaflet of medicinal products for human use were adopted in 2003. These regulatory guidelines are part of Volume 2C of the Notice to Applicants. An amended version of the Guidelines have been prepared in order to reflect the development since publication of the original version. Opinions of the targeted stakeholders on this amended version are sought.

How to submit your contribution

Stakeholders are invited to comment on this consultation by 22 May 2017 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 Public Consultation – Excipients Guidelines".

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); NGO; patient organisation; 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

Responsible service: Directorate-General for Health and Food Safety - Unit B5 - Medicines: policy, authorisation and monitoring.

E-mail: Sante-Pharmaceuticals-B5@ec.europa.eu.

Any queries about the public consultation should be sent to this mailbox.

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

Contributions may be published on the Internet. 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.

Additional information: