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Public Health
ConsultationClosed

Public consultation on draft guidance - Harmonised requirements for non-investigational medicinal products in CTA submissions

Details

Status
Closed
Opening date
Deadline
Department
Directorate-General for Health and Food Safety

Target audience

Public health community

Why we are consulting

Period of consultation

From 1 June 2010 to 30 September 2010.

Contributions to and results of the consultation

Below are the public responses to the above-mentioned public consultation:

Objective of the consultation

This draft guidance aims at clarifying the dossier-requirements for so-called non-investigational medicinal products. It is herewith submitted for public consultation.

The consultation document

The consultation document can be downloaded here.

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.

Additional information:

Respond to the consultation

The response period for this consultation has ended. Thank you for your input.