Medicinal products for human use

Targeted stakeholders consultation on the revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4

Period of consultation

From 20 December 2017 to 20 March 2018.

Objective of the consultation

Annex 1 was first published in 1971, since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow. Key changes are:

  • Introduction of new sections: scope, utilities, Environmental and process monitoring sections and glossary
  • Introduction of QRM Principles
  • Restructured to give more logical flow
  • Added detail to a number of the previous sections to provide further clarity.

Acknowledgment

In order to maintain the global alignment of standards, achieving at the same time assurance for the highest quality, the proposed revised version was prepared in cooperation with WHO and PIC/S. The document will be subject to parallel public consultation by WHO and PIC/S.

How to submit your contribution

Please provide feedback using the template enclosed sending it to SANTE-REVISION-ANNEX-1@ec.europa.eu.

They can also be sent by post to Directorate-General for Health and Food Safety, Unit SANTE B/4, BE-1049 Brussels. The subject line of the letter or email should contain the reference "Targeted Public Consultation – Revision of annex 1 of EU GMP Guide".

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.

The template for comments can be downloaded here.

Contact details

Responsible service: Directorate-General for Health and Food Safety - Unit B4 - Medical Products: quality, safety, innovation.

E-mail: SANTE-REVISION-ANNEX-1@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.