Better Regulation - Major developments

January 2013 : regulation (EC) no 1234/2008 article 4: variations guidelines

In June 2012 the Directorate General for Health and Consumers consulted stakeholders on a contribution to review the guidelines on the details of the various categories of variations. This contribution took into account scientific and technical progress and the recommendations delivered in accordance with Article 5 of the Variations Regulation, since the entry into force of the Regulation in January 2010. In addition, it took into account the necessary update required by the implementation of the new Pharmacovigilance legislation, which entered into force in July 2012.

 A summary of the responses is herepdf(31 KB).

Public responses to the above mentioned public consultation >>>

August 2012 : Application of Articles 28(3), 36 and 37 of Regulation 1901/2006.

This procedural note explains the impact of the adoption of the new rules on variations on the application of Articles 28(3), 36 and 37 of the Paediatric Regulation. The note can be found herepdf(9 KB).

June 2012 : Public Consultation Paper on the review of the Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.

Commission Regulation (EC) No 1234/2008 establishes in its Article 4(2) that the guidelines on the details of the various categories of variations shall be regularly updated, taking into account the recommendations delivered in accordance with Article 5 of this Regulation.

With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on a contribution to the review of the above mentioned guidelines. This contribution is an input from the EU Variation Task Force coordinated by EMA and it will form the basis for the review of the Commission variations guidelines. The public consultation paper can be found herepdf(2 MB)
February 2012 : Outcome of the public consultation on the review of Regulation (EC) 1234/2008  

In October 2011 Directorate General for Health and Consumers consulted stakeholders on the review of the Variations Regulation. In particular, the consultation aimed to collect views on the following items:

  1.  The extension of the scope of the Variations Regulation to purely national marketing authorisations.
  2. The adjustment of some of the procedures with a view to focus resources of the authorities on variations with the most impact on public health. 
  3. Some workability concerns identified.
  4. Whether, in the light of the experience of last year, the procedure for the authorisation of vaccines in a pandemic setting should be amended. 

A summary and all contributions received from stakeholders regarding the above mentioned public consultation can be found here.

October 2011 : Public Consultation Paper on the review of Regulation (EC) 1234/2008 to the handling of variations to purely national marketing authorisations.

In 2006, the European Commission initiated an ambitious project to revise the overall framework for variations to make the whole system simpler, clearer and more flexible without compromising public health. The new regulatory framework on variations is the Commission’s main contribution to the ‘Better Regulation’ policy agenda in the field of pharmaceuticals. The final step to conclude the adoption of the variations’ initiative will be the amendment of Regulation (EC) No 1234/2008 to enlarge its scope to include purely national authorisations, in accordance with the mandate given by Directive 2009/53/EC. 

With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on the following items:
(1) The extension of the scope of the Variations Regulation to purely national marketing authorisations.
(2) The adjustment of some of the procedures with a view to focus resources of the authorities on variations with the most impact on public health. 
(3) Some workability concerns identified.
(4) Whether, in the light of the experience of last year, the procedure for the authorisation of vaccines in a pandemic setting should be amended.
It can be found here.pdf(37 KB)

December 2009 : Implementation of the Variations Regulation : Communication from the Commission - Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.

The Commission “Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products” following Article 4(1)(b) of this Regulation was adopted by the Commission on 21 December 2009 and shall be published in the Official Journal before the end of the year. The guideline applies from 1 January 2010.

The text of the guideline is available herepdf(91 KB).

December 2009 : Implementation of the Variations Regulation : Communication from the Commission - Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products

The Commission “Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products”

following Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products was adopted by the Commission on 21 December 2009 and shall be published in the Official Journal before the end of the year. The guideline applies from 1 January 2010.

The text of the guideline is available here :   Pdf versionpdf(276 KB)Word versionmsw8(2 MB).

December 2009 : Implementation of the Variations Regulation: Draft application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure in accordance with Commission Regulation (EC) No 1234/2008 of 24 November.

Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products shall apply from 1 January 2010. In accordance with the operation of the procedures laid down in this Commission Regulation, a new application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure has been developed.

This document does not represent the official position of the European Commission; however, it is a stable document published to facilitate preparation by stakeholders for the implementation of the variations regulation. The draft application form can be found here : pdf versionpdf(140 KB) - word versionmsw8(2 MB).

November 2009 : Draft Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.

Article 4(1)(b) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products establishes that the Commission shall, after consulting the Member States, the Agency and interested parties, draw up guidelines on the operation of the procedures laid down in Chapters II, III and IV of this regulation as well as on the documentation to be submitted pursuant to these procedures.

Following several months of consultations, DG ENTR has drawn up a draft guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 as well as on the documentation to be submitted pursuant to these procedures.This document does not represent the official position of the European Commission; however, it is a stable document published to facilitate preparation by stakeholders for the implementation of the variations regulation. The draft guideline can be found here.

This draft guideline is now being translated into the official languages for submission to the European Commission for adoption of the final guidelinepdf(91 KB).

November 2009 : Draft Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products

Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products establishes that the Commission shall, after consulting the Member States, the Agency and interested parties, draw up guidelines on the details of the various categories of variations.

Following several months of consultations, DG ENTR has drawn up a draft guideline on the details of the various categories of variations. This document does not represent the official position of the European Commission; however, it is a stable document published to facilitate preparation by stakeholders for the implementation of the variations regulation. The draft guideline can be found here.

 This draft guideline is now being translated into the official languages for submission to the European Commission for adoption of the final guidelinpdf(277 KB)e.  

July 2009: Variations (codecision part): publication of amendments to Directive 2001/82/EC and Directive 2001/83/EC.

Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products, has been published in the Official Journal on 30 June 2009. This Directive is part of a global revision of the legal framework on variations to make the overall system clearer, simpler and more flexible and it amends the legal basis for the adoption of Community rules on variations in order to harmonise those rules for all authorised medicines in the EU.
EudraLex Vol 1 >>
EudraLex Vol 5 >>

July 2009 : Implementation of the Variations Regulation : Guidelines on the details of the various categories of variations

Summary and contributions from stakeholders to the public consultation paper for the preparation of guidelines on the details of the various categories of variations.
Directorate General for Enterprise and Industry consulted stakeholders on a contribution to the preparation of the guidelines on the details of the various categories of variations following Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products. A summary and all contributions received from stakeholders regarding the above mentioned public consultation can be found here.

July 2009: Implementation of the Variations Regulation: Guidelines on the operation of the variation procedures.

Summary and contributions from stakeholders to the public consultation paper for the preparation of guidelines on the operation of the variation procedures.
Directorate General for Enterprise and Industry consulted stakeholders on a contribution to the preparation of the guidelines on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products, following Article 4(1)(b) of the Regulation. A summary and all contributions received from stakeholders regarding the above mentioned public consultation can be found here.

12 December 2008

On 12 December the "Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products", was published in the Official Journal of the European Union (OJ L 334 p. 7). In line with Article 28 "this Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union".
Click here to access the Regulationpdf

22 October 2008: Variations (codecision part): first reading vote in the European Parliament on the Commission proposal

On 22 October, the European Parliament (EP) has voted in first reading on the Commission proposal for a Directive amending Directive 2001/83/EC and Directive 2001/82/EC as regards variations to the terms of marketing authorisations. The proposal is part of a global revision of the legal framework on variations to make the overall system clearer, simpler and more flexible. This proposal in particular aims at amending the legal basis for the adoption of Community rules on variations in order harmonise those rules for all authorised medicines in the EU.
The final EP opinion has been adopted with a very large majority. The EP has endorsed the objectives and key elements of the Commission proposal and has introduced certain amendments. These include in particular the clarification that the implementing rules by the Commission should ensure simplification and the introduction of a possibility for Member States to continue applying national rules on variations to medicinal products fulfilling certain conditions. The EP's legislative resolution and the Commission proposal, after introduction of the EP amendments, can be found herepdf(73 KB) .

This first reading opinion of the European Parliament paves the way for adoption of the text by the Council and the EP without a need for a second reading.

10 June 2008: Better Regulation of pharmaceuticals: Revision of the Variations Regulations: Commission delivers on cutting red tape

On 10 June 2008, the Member States have approved the new Commission Regulation on variations which will replace the existing Regulations (EC) No 1084/2003 and 1085/2003. The draft Regulation was put to vote at a joint meeting of the Standing Committee on Medicinal Products for Human Use and the Standing Committee for Veterinary Medicinal Products. Both Committees issued a favourable opinion by a very large majority.

The agreed text now enters a 3-months period of scrutiny by the European Parliament and Council (until 13 September 2008), before it can be formally adopted by the Commission and enters into force. For economic operators, the new rules will apply one year after entry into force, i.e. most likely around Q4 2009.

The text of the Regulation which was approved on 10 June 2008 is available herepdf .

Please note that some of these linguistic versions may still be subject to minor linguistic editorial amendments.

For any questions, please contact entr-pharmaceuticals@ec.europa.eu .

4 March 2008: adoption of the Commission proposal on variations (co-decision part)

On 4 March 2008, the Commission has adopted its proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products. The proposal is available herepdf in all EU official languages.

The proposal is accompanied by an [ Impact Assessmentpdf(493 KB) ].

14 January 2008: Outcome of the Public Consultation (comitology part)

A public consultation was conducted in October 2007-January 2008 on the 'comitology' aspects of the review of the Variations Regulations.

Comments from stakeholders are available [here].

A summary of the outcome of this consultation is available [here]pdf.

For any questions, please contact entr-pharmaceuticals@ec.europa.eu

25 October 2007: Public Consultation Review of the Variations Regulations (comitology part)

Commission launches a Public Consultation on the comitology part of the revision of the Variations Regulations, on the basis of two documents:

· The draft legal proposal is available herepdf(230 KB)

· The Consultation paper, which gives detailed explanations on the consultation process as well as on the content of the draft legal proposal, is available herepdf(72 KB) .

This public consultation only addresses the 'comitology' part of this Better Regulation initiative. It does not address the aspects of the review which require 'co-decision'. These aspects have already been adressed in a previous consultation.
Comments on the draft legal proposal and on the Consultation paper should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu before Friday 4 January 2008.

3 October 2007: Outcome of the Public Consultation (co-decision part)

A public consultation was conducted in July-September 2007 on the co-decision aspects of the review of the Variations Regulations.
A summary of the outcome of this consultation is available [here]pdf(20 KB) .
Comments from stakeholders are available [here].
For any questions, please contact entr-pharmaceuticals@ec.europa.eu

10 July 2007: Public Consultation (co-decision part)

Commission launches a Public Consultation on the co-decision part of the revision of the Variations Regulations. The consultation paper, together with detailed explanations on the consultation process, is available herepdf(61 KB) . This public consultation only addresses the 'co-decision' part of this Better Regulation initiative. It does not address the aspects of the review which can be implemented through 'comitology'. These aspects will be addressed in another round of consultation.
Comments should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu before 21 September 2007.

Background documents

The Commission already conducted a targeted consultation in October 2006-January 2007 with industry associations and Member States competent authorities, on the basis of the following Issue paper.pdf This document outlines key issues where possible improvements of the current legislative framework on variations have been identified.

The current legislation on Variations (Regulations (EC) No 1084/2003 and 1085/2003) can be found here.