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Revision of the variation framework for medicines

Public health

This initiative, announced in the Pharmaceutical Strategy for Europe, aims to review the current rules setting out the procedures for post-authorisation changes to a marketing authorisation for medicines for human use. The purpose is to make the lifecycle management of medicines more efficient.

Links

Public consultation

ID: 13561

Lobbying Activity

26 responses

Consultation response

European Federation of Pharmaceutical Industries and Associations, 29 Feb 2024

EFPIA/Vaccines Europe fully support revision of the EU variations framework and agree with the stated aim of this first step to streamline procedures and ensure better handling based on a science and risk-based approach. We are encouraged to see the inclusion of the following changes: Removal of…

Consultation response

European Federation of Pharmaceutical Industries and Associations, 25 Sept 2023

EFPIA/Vaccines Europe (VE) fully support the need to revise the EU variations framework. We believe such a revision must be extensive and enable a science- and risk-based approach to lifecycle management, allowing the future framework to keep pace with innovation and ensure a sustainable supply of…

Consultation response

MEDICINES FOR EUROPE, 29 Feb 2024

Medicines for Europe welcomes the opportunity to comment on the EC proposal to revise the Variations Regulation 1234/ 2008. The current regulatory framework for maintaining products on the market needs to continue evolving to better reflect scientific progress and operational efficiency to reduce…

Medicines for Europe Urges Slashing Red Tape in Pharma Rules

MEDICINES FOR EUROPE, 26 Sept 2023

They propose streamlining the variations system by grouping related changes and introducing silent approvals. The industry also requests that minor changes affecting one state be handled solely by that country.
These changes would lower compliance costs and prevent medicine shortages caused by bureaucratic delays.
National regulators may lose direct oversight of changes that no longer require their explicit prior approval.

Consultation response

EuropaBio, 29 Feb 2024

EuropaBio welcomes the initiative from the European Commission to revise the variation framework last updated by the Commission Regulation (EU) No 712/2012. In the light of the Pharmaceutical Strategy for Europe, the need to revise the variation framework in a stepwise approach is particularly…

EuropaBio Urges Simpler Rules for Biotech Medicine Approval Updates

EuropaBio, 26 Sept 2023

EuropaBio requests harmonising change categorisation and reconsidering the default complex review status for biologics. They suggest using non-legislative changes, such as IT updates, to reduce current administrative burdens.
This would reduce the heavy resource burden required to maintain marketing authorisations.

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 29 Feb 2024

Please find attached feedback on behalf of EUCOPE.

EUCOPE Urges Reform of Medicine Market Authorisation Changes

European Confederation of Pharmaceutical Entrepreneurs, 26 Sept 2023

EUCOPE requests that the European Commission embrace risk-based approaches to simplify medicine lifecycle management. They advocate for downregulating biological products and reducing the administrative burden of minor notifications. These reforms aim to facilitate innovation and avoid drug shortages by streamlining technical updates.
The industry would benefit from significantly lower compliance costs and faster technical implementation.

Consultation response

Association of the European Self-Care Industry, 29 Feb 2024

AESGP, the Association of the European Self-Care Industry, represents manufacturers of non-prescription medicines (NPM). We appreciate the opportunity to be consulted on the draft Delegated Regulation on Variation. We appreciate that some of the proposals seem to address some of the issues we have…

Self-care industry urges automated updates for medicine variations

Association of the European Self-Care Industry, 26 Sept 2023

AESGP requests automatic processing for administrative updates and simpler rules for lower-risk changes. They seek equal treatment for herbal and chemical ingredients.
Faster updates and lower compliance costs would improve their market responsiveness.

Health mutuals demand more transparency in medicine variation rules

Association Internationale de la Mutualité, 26 Sept 2023

AIM calls for more transparency and proactive information on changes impacting medicine safety. They request a searchable database to track variations and history of product indications.
Better information helps members manage pricing committees and evaluate the benefit-risk profile of drugs.
Drug manufacturers could see increased transparency requirements and more stringent evidence standards for updates.

Consultation response

Pharma Deutschland e.V, 28 Feb 2024

Der BAH unterstützt den vorgelegten Entwurf einer delegierten Verordnung zur Änderung der Verordnung (EG) Nr. 1234/2008 (Variation-Verordnung), sieht aber weiteren Raum für Optimierungen, um dem ursprünglichen Ziel, den Prozess der Änderungen von Zulassungen zu rationalisieren und zu vereinfachen,…

Pharma Deutschland Urges More Flexible Medicine Lifecycle Management Rules

Pharma Deutschland e.V, 26 Sept 2023

Pharma Deutschland requests a more flexible framework to make the lifecycle management of medicines more efficient. They propose extending the risk-based approach to all medicines and simplifying grouping and worksharing procedures. They also advocate for digital solutions to report minor changes through existing databases.
Streamlined rules would significantly lower administrative costs and resource burdens for pharmaceutical manufacturers.

CSL Behring Urges Faster EU Medicine Variation Rules

CSL Behring, 26 Sept 2023

CSL Behring supports simplified procedures and removing administrative complexity for biological medicines. They advocate for risk-based principles across all products and a streamlined plasma master file process.
Updated rules would allow the company to manage product changes more efficiently.

Consultation response

Bundesverband der Pharmazeutischen Industrie e.V., 26 Feb 2024

The revision of the Commission Regulation (EC) No. 1234/2008 in the first step presents little evidence of reducing bureaucracy and deregulation. Some of the amendments seem a restriction to industry reducing flexibility. An opening clause to update regulatory information by using digital tools…

German Drug Industry Urges Simplification of Medicine Variation Rules

Bundesverband der Pharmazeutischen Industrie e.V., 22 Sept 2023

BPI calls to simplify the variation system and reflect regulatory needs using digital technology. The own responsibility of the marketing authorisation holder should be strengthened in the regulation.
This would lower high maintenance costs and restore essential production planning security.
Regulatory authorities would lose their power to verify new safety information before implementation.

Consultation response

BioNTech SE, 29 Feb 2024

BioNTech appreciates the opportunity to share a comment: We suggest that an option for an off-cycle update to human coronavirus vaccines, if needed (e.g. new variant of pandemic potential), should be added to Article 18. We additionally suggest that an off-cycle update submission should follow a…

Hospital pharmacists urge preserving information in medicine rule changes

The European Association of Hospital Pharmacists, 21 Sept 2023

The association requests that streamlining regulations does not reduce the data available to healthcare professionals. They emphasize that maintaining detailed product information is critical for patient safety.
Retaining comprehensive records helps pharmacists avoid increased workloads and ensures treatment accuracy.
Patients risk safety issues if streamlined procedures lead to insufficient medicinal information.

Consultation response

Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose, 29 Feb 2024

PPTA welcomes the revision of the Variations Regulation (EC) 1234/2008 and recognises the importance of streamlined and agile provisions for medicines lifecycle management and post-authorisation changes in the EU. The amendments to the Regulation aimed at reducing administrative burden and…

Plasma industry group urges simpler rules to speed supply

Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose, 26 Sept 2023

The group wants to remove redundant administrative steps for plasma collection. They advocate for reclassifying notifications to a less burdensome category.
These changes would lower administrative costs and prevent delays in plasma production.
National regulators would lose their role in performing secondary administrative reviews of plasma files.

Consultation response

Association Mieux Prescrire, 28 Feb 2024

See attached Prescrires position paper on the proposed revision of the European Commission delegated regulation related to the examination of marketing authorisation variations with a focus on: robust marketing authorisations transparency medical devices

Consultation response

Association Mieux Prescrire, 21 Sept 2023

Please find attached Prescrire's feedback to the consultation on the revision of the variation framework for medicines.

Consultation response

PETA Science Consortium International e.V., 27 Feb 2024

PETA Science Consortium International e.V. promotes robust non-animal testing methods that protect human health and the environment. We welcome the opportunity to comment on the initiative Pharmaceuticals changes to marketing authorisations. Please find our response attached.

Consultation response

European Coalition on Homeopathic and Anthroposophic Medicinal Products, 28 Feb 2024

ECHAMP, the European Coalition on Homeopathic and Anthroposophic Medicinal Products, welcomes the consultation on the draft Delegated Regulation on Variations. We are aware that this revision of the Commission regulation (EC) No.1234/2008 is a strictly targeted one. The second phase of review being…

Consultation response

International Society for Pharmaceutical Engineering, 19 Sept 2023

Please see attached feedback from the International Society for Pharmaceutical Engineering (ISPE). ISPE is a not-for-profit organization of individual members from pharmaceutical companies, contract manufacturing organizations, suppliers and service providers, and health authorities. The 21,000+…

Consultation response

HTA Austria Austrian Institute für Health Technology Assessment, 11 Sept 2023

We very much support the overhaul of the current pharmaceutical legislation in favor of innovation for the (Austrian) patients. AIHTA appreciates some propositions in the proposal and welcomes the direction of these, proving that the EC is willing to address the numerous market failures. Though…