Targeted stakeholders’ consultation of the revision of Annex 21, on importation of medicinal products

The Union legislation addresses all actors in the supply chain and defines their roles 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 considered 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.

For further information visit the official consultation page of European Commission, Directorate-General for Health and Food Safety.

The draft guideline Annex 21 can be dowloaded at this link.

Consultation Deadline: 20th August 2020

Second targeted stakeholders’ consultation on the revision of Annex 1, on manufacturing of sterile medicinal products

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introduced in several sections, it was agreed to engage with stakeholders a second targeted consultation on the updated draft guidance (version 12) focused on the sections and/or significantly modified paragraphs that raised most concerns by stakeholders.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.

For further information visit the official consultation page of European Commission, Directorate-General for Health and Food Safety.

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.

Consultation Deadline: 20th July 2020

PharmSci Today podcast

Professor Gino Martini, Chief Scientist for the Royal Pharmaceutical Society in Great Britain talks about the latest issues, innovations and developments in the Pharmaceutical Sciences and research. EIPG is collaborating with the RPS to include their podcasts in issues of our #ICYMI and the EIPG Pharma Weekly Roundup edition. 

In this latest podcast #12, Gino and Sarah Cahill talk to Dr Sheuli Porkess, Executive Director for Research, Medicine and Innovation at the Association of the British Pharmaceutical Industry. They discuss some of the remarkable research efforts currently underway to find treatments and a vaccine for Covid-19.