Position Papers

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25th March 2024
Environmental sustainability: the EIPG perspective

EIPG has started the preparation of a document that analyses the main critical areas of the entire production process of a medicinal product and sets out its position on the interventions considered a priority in a perspective of changes that will lead to the inclusion of new methods alternative material resources and will require new skills.

24th November 2023
The drug shortage situation – EIPG’s point of view

Everyone in industry agrees that problems of shortages are complex with no quick solutions. Several factors can be identified as being at the root of the shortage of medicines, some of which intersect with each other, mainly concerning aspects with technical, qualitative, regulatory, forecasting, supply, speculative and economic implications.

8th November 2023
EIPG’s position paper on the revised Pharmaceutical legislation

5th December 2019
Addressing the root causes of medicines shortages: Supply chain Stakeholders’ views on root causes and solutions.

15th May 2019
EIPG Comments on European Medicines Agency draft guideline on the quality of water for pharmaceutical use.

2nd March 2018
Supply chain commitment to tackling problem of medicine shortages.

19th March 2018
EIPG Feedback on the Revision to Annex 1 (Manufacture of Sterile Medicinal Products).

21st August 2017
EIPG Comments on the European Medicines Agency draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol.

19th May 2017
EIPG Comments on the European Commission targeted stakeholder consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use.

2nd May 2017
EIPG Comments on the European Medicines Agency draft Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012).

3rd February 2017
Joint Supply Chain Actors Statement on Information and Medicinal Products Shortages.

1st January 2017
EIPG Comments on the European Medicines Agency draft concept paper on Good Manufacturing Practice and Marketing Authorisation Holders.

4th November 2016
EIPG Comments on the European Medicines Agency draft Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies.

26th September 2016
EIPG Comments on the European Commission targeted stakeholder consultation on the draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products.

24th November 2015
EIPG Feedback on the European Commission public consultation on a Commission Delegated Act on principles and guidelines on good manufacturing practice for investigational medicinal products and on inspection procedures, pursuant to the first subparagraph of Article 63(1) of Regulation (EU) No 536/2014 and Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014.

22nd July 2015
EIPG Feedback on the European Medicines Agency concept paper on the development of a guideline on quality and equivalence of topical products.

19th May 2014
EIPG Feedback on the Revision of Annex 15 (Qualification and Validation).

8th November 2013
EIPG Feedback on the Revision to Annex 16 (Certification by a Qualified Person and Batch Release).

29th April 2012
EIPG response to the consultation on a unique identifier for medicinal products.

22nd April 2012
Comments from the European Industrial Pharmacists Group on the extension of the Directive on GMP for medicinal products to active substances.

25th March 2012
Comments from the European Industrial Pharmacists Group on the Implementing Act on the Requirements for the Assessment of the Regulatory Framework applicable to the Manufacturing of Active Substances of Medicinal Products for Human Use.

5th February 2012
Comments from the European Industrial Pharmacists Group on the Commission’s Concept Paper on the Revision of Annex 16.

31st December 2011
Comments from the European Industrial Pharmacists Group on the Commission’s Revised Guidelines on Good Distribution Practice of Medicinal Products for Human Use.

14th September 2011
EIPG Response to the Green Paper on Modernising the Professional Qualifications Directive.

28th April 2011
EIPG Comments on ‘Template for the Qualified Person’s declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain “The QP declaration template”’ (EMA/CHMP/CVMP/QWP/696270/2010).

15th March 2011
EIPG response to the Consultation on Professional Qualifications Directive.

26th February 2011
EIPG Consolidated Responses to Concept Papers on Storage Conditions During Transport.

GMP Chapter 6

Proposed revisions of GMP Chapter 5

Proposed revisions of GMP Chapter 7

20th July 2010
EIPG Consolidated Response to proposed changes to GMP Chapters 1 and 2.

4th October 2009
Comments from the European Industrial Pharmacists Group on the European Commission Proposals for the Provision of Information to Patients on Prescription Medicines.

27th October 2008
EIPG Response to Consultation on Annex 13.

2nd June 2008
Concept Paper on a Guideline on Chemical and Pharmaceutical Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials.

7th May 2008
Contribution from Groupement des Pharmaciens de L’Industrie en Europe (European Industrial Pharmacists’ Group), to the Public Consultation in Preparation of a legal proposal to combat Counterfeit Medicines for Human Use.

7th June 2007
The Responsible Person and Wholesale Supply in the UK.