Open consultations

Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu.

Comments should be provided using this template to hmpc.secretariat@ema.europa.eu 

Comments should be provided using this template to hmpc.secretariat@ema.europa.eu 

Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu 

Comments should be provided using this template. The completed comments form should be sent to ScientificAdvice@ema.europa.eu 

This concept paper aims to outline the rationale, objectives, and proposed changes for updating Part IV – GMP specific to ATMP of the good manufacturing practice (GMP) guide Eudralex Volume 4 following the revision of Annex 1 which came into operation in August 2023. As the Part IV is an EU standalone guideline and that the sector is to abide solely for reference, it should be revised independently to address recent developments in the manufacture of sterile medicinal products.

Those participating in the public consultation are asked to please submit comments via the EU Survey tool.

Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu 

This concept paper provides background to the intended development of a scientific approach for use in the evaluation of the risk for humans exposed to antimicrobial resistance via the environment, originating from use of veterinary medicinal products. It is intended to provide advice on how relevant dossier requirements outlined in Regulation (EU) 2019/6 (e.g., Article 8(2)) may be fulfilled.

Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu

The ongoing revision of the QRD template started in September 2023, mainly triggered by the Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. This report is an assessment of shortcomings in the summary of product characteristics (SmPC) and the package leaflet (PL), and it provides some recommendations on how they could be improved to better meet the needs of patients and healthcare professionals.

In addition, the revision has also considered the extensive experience gained over the years by the EMA Labelling Office and the QRD members, the voice of patients, consumers and healthcare professionals, the feedback provided by stakeholders performing consultation with target patients’ groups (so called user testing), and the work performed by some industry stakeholders on the improvement of the PL.