Medicinal products

Second targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4

Deadline postponed for the second targeted consultation on Annex 1
 
Due to the challenges posed by COVID-19, the timeline for the second targeted consultation has been extended until 20 July 2020.  

Those who have already submitted their comments are welcome to revise their contribution if they would like to. Only their latest comments will be considered. 
 
The European Commission remain at your disposal in case you would have any further questions at : SANTE-REVISION-OF-ANNEX-1@ec.europa.eu

Period of consultation

From 20 February 2020 to 20 July 2020.

Objective of the consultation

Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients.

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;
  • Introduction of QRM Principles;
  • Restructured to give more logical flow;
  • Added detail to a number of the previous sections to provide further clarity.

A first targeted consultation conducted from 20 December 2017 to 20 March 2018 allowed about 140 companies and/or organizations to comment. The drafting group processed more than 6200 lines of comments.

Due to widespread interest from industry following the first targeted consultation, and because of substantial modifications introduced in several sections, it was agreed to engage with stakeholders a second targeted consultation on the updated draft guidance (version 12) focused on the sections and/or significantly modified paragraphs that raised most concerns by stakeholders.

The second targeted consultation aims at collecting experience from the sectors on certain manufacturing steps. The European Commission therefore expect to receive contribution from the European associations representing the sectors.

Acknowledgment

In order to maintain the global alignment of standards, achieving at the same time assurance for the highest quality, the document will be, in parallel, subject to a second targeted consultation by WHO and PIC/S.

Targeted stakeholders

The following organisations representing relevant stakeholders accepted to take part in the second consultation and agreed to receive all the comments of this second consultation from their members, to compile and send the comments to the European Commission: 

  • A3P (Association for Products Propres and Parentals)
  • AESGP (Association of the European Self-Medication Industry)
  • AnimalhealthEurope
  • APIC (Active Pharmaceutical Ingredient Committee)
  • EAEPC (European Association of Euro-Pharmaceutical Companies)
  • ECA (European Compliance Academy)
  • EFPIA (European Federation of Pharmaceutical Industries and Associations)
  • EGGVP (European Group for Generic Veterinary Products)
  • EIPG (European Industrial Pharmacists Group)
  • GIRP (European Healthcare Distribution Association)
  • ISPE (International Society for Pharmaceutical Engineering)
  • Medicines for Europe
  • PDA (Parenteral Drug Association)
  • PHSS (Pharmaceutical & Healthcare Sciences Society)
  • EQPA (European Qualified Person Association)
  • Vaccines Europe

The listed stakeholders received a template for response highlighting the sections and chapters of the new draft Annex 1 on which the second consultation is focussed.

The consultation document

Download the draft guideline under consultation

How to submit a contribution

If you wish to participate in the second targeted consultation and you are a member of one of the above listed organisations, please contact the relevant organisation to submit your comments.
If you wish to participate and you are not a member of one of the above listed organisations, please, send an e-mail to SANTE-REVISION-OF-ANNEX-1@ec.europa.eu.
You will receive the dedicated template for the response. The filled in template should be returned to the same mailbox or 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 "Second Targeted Public Consultation – Revision of annex 1 of EU GMP Guide".

Please include in your response your name, e-mail address, and specify if you are responding as an individual or as a representative of an organisation.

Protection of personal data

Please consult the Privacy Statement.

Contact details

Responsible service: Health and Food Safety Directorate General.
Unit B4 - Medical products: quality, safety, innovation
Any queries about the public consultation should be sent to: SANTE-REVISION-OF-ANNEX-1@ec.europa.eu.