Medicinal products

Targeted stakeholders' consultation on Annex 21: Importation of medicinal products, of the Eudralex volume 4

Deadline postponed for the targeted consultation on Annex 21  

Due to the challenges posed by COVID-19, the timeline for the targeted consultation has been extended until 20 August 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. 

 We remain at your disposal in case you would have any further questions at: SANTE-REVISION-OF-ANNEX-21@ec.europa.eu

Period of consultation

From 20 March 2020 to 20 August 2020.

Objective of the consultation

The Union legislation addresses all actors in the supply chain and defines their roles in order to ensure the integrity of the supply chain of medicinal products. The importation of medicinal products is, in light of Article 40(3) of Directive 2001/83/EC, subject to GMP requirements. In addition to the guidance given in the main chapters and annexes of the EU GMP it has become necessary to publish a specific guideline clarifying the application of the principles of GMP in the activity of importation of medicinal products under Annex 21 of the GMP guideline.. This Annex sets out the principles and guidelines of good practice requirements applicable to a manufacturing and importation authorisation (MIA) holder, which imports medicinal products (human and veterinary) through the EU/EEA borders. 

The comments received will be taken into account by the European Commission in the finalisation of the Guideline on the good practice applicable to importation of human and veterinary medicinal products, across the borders, into the EU/EEA.

How to submit your contribution

All stakeholders involved in activities related to importation of human and veterinary medicinal products, across EU/EEA borders, are invited to respond on this consultation by sending their comments on the template attached. Responses should preferably be sent to SANTE-REVISION-OF-ANNEX-21@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 21 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 draft guideline Annex 21

The response template for comments

Contact details

Responsible service: Health and Food Safety Directorate General.

Unit B4 - Medicinal products: quality, safety, innovation

E-mail: SANTE-REVISION-OF-ANNEX-21@ec.europa.eu.

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

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.