Open consultations

11 February - 31 May 2014

Call for Information for a scientific opinion on the safety of Silica (nano)


Under : Scientific Committees

Closed consultations

06 February 2014

Revision of European Commission Guidelines on Good Manufacturing Practice for Medicinal Products

The public consultation concerns the revision of Annex 15: Qualification and Validation.

Deadline for comments on this draft: 31 May 2014. Comments should be sent by e-mail to: ADM-GMDP@ema.europa.eu and sanco-pharmaceuticals-D6@ec.europa.eu. Please consult the privacy statement on this consultation.


Under : Pharmaceuticals

04 December 2013 - 28 February 2014

Public consultation on patient safety and quality of care


Under : Patient safety

05 July - 05 November 2013

Public consultation on the revision of EU Commission guidelines on Good Manufacturing Practice for Medicinal Products

Public consultation on the revision of the Annex 16: Certification by a Qualified Person and Batch Release. Stakeholders are invited to comment on this draft by 5 November 2013 at the latest. Comments should be sent by email to: ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu
Under : Medicinal products for human use

05 July - 30 September 2013

Public consultation on the guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another

Comments and suggestions are invited by 30 September 2013 and should be sent by email to:
sanco-pharmaceuticals-d5@ec.europa.eu
Under : Medicinal products for human use

29 May - 23 June 2013

Call for experts in the Synthetic Biology area (SynBio)


Under : Scientific Committees

06 February - 30 April 2013

Public consultation on draft guidelines on the principles of good distribution practices for active substances for medicinal products for human use

Stakeholders are invited to comment on this draft by 30 April 2013 at the latest. Responses should be sent preferably by e-mail to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.
Under : Medicinal products for human use

06 February - 30 April 2013

Public consultation on draft guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use

Stakeholders are invited to comment on this draft by 30 April 2013 at the latest. Responses should be sent preferably by e-mail to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.
Under : Medicinal products for human use

06 February - 02 April 2013

Public consultation on draft template for the qualified person’s declaration concerning GMP compliance of investigational medicinal products manufactured in non-EU countries

Stakeholders are invited to comment on this draft by 2 April 2013 at the latest. Responses should be sent preferably by e-mail to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.
Under : Medicinal products for human use

17 January - 18 July 2013

Public Consultation on the revision of EU Commission guidelines on Good manufacturing Practice Medicinal Products

The European Commission launched the public consultation of the following revised guidelines on good manufacturing practices:
Chapter 3: Premises and Equipment, Chapter 5: Production, Chapter 6: Quality Control, Chapter 8: Complaints, Quality Defects and Product Recalls.
Under : Medicinal products for human use

20 December 2012 - 31 March 2013

Public consultation on advanced therapy medicinal products

A summary of the responses to the public consultation on the Regulation on Advanced Therapies as well as the responses can be found here.


Under : Medicinal products for human use

28 November 2012 - 18 February 2013

Public consultation on post-authorisation efficacy studies


Under : Medicinal products for human use

19 October - 30 November 2012

Public Consultation on the Discussion paper addressing the New Challenges for Risk Assessment


Under : Scientific Committees

17 October 2012 - 17 January 2013

Public consultation on the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public

Concept paper for public consultation on the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public.


Under : Medicinal products for human use

13 October - 23 November 2012

Call for Experts to provide advice on effective ways of investing in health


Under : Healthcare

31 August - 15 October 2012

Call for experts on the safety assessment of nanomaterials in cosmetic products


Under : Scientific Committees

10 August - 01 October 2012

Call for experts on medical devices containing nanomaterials


Under : Scientific Committees

10 August - 10 October 2012

Call for experts on the use of dental amalgam and its substitutes


Under : Scientific Committees

08 August - 10 October 2012

Call for information on the safety of the use of dental amalgam and its substitutes


Under : Scientific Committees

08 August - 10 October 2012

Call for information on the safety of medical devices containing nanomaterials


Under : Scientific Committees

06 August - 24 September 2012

Call for experts on metal-on-metal hip implants

Call for expression of interest for experts in metal-on-metal hip implants


Under : Scientific Committees

06 August - 24 September 2012

Call for experts in EMF

Call for expression of interest for experts in Potential health effects of exposure to electromagnetic fields (EMF)


Under : Scientific Committees

06 August - 24 September 2012

Call for experts on medical devices containing DEHP

Call for expression of interest for experts on the safety of medical devices containing DEHP [di(2-ethylhexyl) phthalate]


Under : Scientific Committees

14 March - 15 April 2012

Invitation to provide input to the Chronic Disease reflection process

Additional information: Questionnaire addressed to stakeholders


Under : Major and chronic diseases

29 February - 20 April 2012

Call for information on safety of bisphenol A in medical devices


Under : Scientific Committees

20 January - 20 April 2012

Delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use - concept paper submitted for public consultation

Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ('GMP') for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paper is being released for public consultation with a view to preparing the delegated act on principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.


Under : Medicinal products for human use

20 December 2011 - 29 February 2012

Public consultation on the SCCS preliminary opinion on fragrance allergens in cosmetic products


Under : Scientific Committees

07 December 2011 - 23 March 2012

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 - Concept paper submitted for public consultation

Directive 2011/62/EU introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The requirement of a written confirmation is waived for third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements. This concept paper is being rolled out for public consultation with a view to preparing this implementing act.


Under : Medicinal products for human use

18 November 2011 - 27 April 2012

Delegated act on the detailed rules for a unique identifier for medicinal products for human use, and its verification - Concept paper submitted for public consultation

Directive 2011/62/EU introduces obligatory 'safety features' to allow, inter alia, verification of the authenticity of medicinal products for human use ('unique identifier'). The Directive places the Commission under an obligation to adopt delegated acts setting out the details relating to inter alia the unique identifier. This concept paper is being rolled out for public consultation with a view to preparing both the impact assessment and the delegated act.


Under : Medicinal products for human use

08 October - 15 November 2011

Call for experts 2011: Join the Advisory Structure of Scientific Committees and database of experts

The European Commission invites scientists to join its Advisory Structure of Scientific Committees and Database of Experts. The deadline for applications is 15 November 2011


Under

13 April - 10 June 2011

Public consultation on a concept paper on an amendment of Commission Regulation (EC) No 658/2007 concerning financial penalties committed by marketing authorisation holders

The European Commission is planning to put forward, a limited and targeted amendment to Commission Regulation (EC) No 658/2007 concerning financial penalties for certain obligations in connection with centrally authorised medicinal products in the human and in the veterinary sector.
The purpose of this amendment is two-fold. Firstly, to fulfil the mandate given by the legislator in the Paediatric Regulation (EC) No 1901/2006 and secondly, to adapt Commission Regulation (EC) No 658/2007 to the modifications introduced by the new pharmacovigilance legislation in the human sector.


Under : Medicinal products for human use

04 March - 31 May 2011

Stakeholder consultation on health security in the European Union


Under : Preparedness and response

09 February - 13 May 2011

Public consultation on a concept paper on the revision of the 'Clinical Trials Directive' 2001/20/EC

The European Commission is planning to put forward, in 2012, a legislative proposal to revise the Clinical Trials Directive 2001/20/EC.


Under : Medicinal products for human use

17 November - 17 December 2010

Stakeholder Consultation on the Transatlantic Task Force on antimicrobial resistance


Under : Antimicrobial resistance

12 November 2010 - 31 January 2011

Public consultation on the Conclusions of the Fifth Report on Economic, Social and Territorial Cohesion


Under : Health and structural funds

05 August 2010

Qualification of hygienic tampons containing lactic acid producing baceria

Public Consultation outcome


Under : Medical devices

15 July - 01 September 2010

Call for experts in ophthalmology

Call for expression of interest for experts in ophthalmology in relation to the work on health effects of artificial light.


Under : Scientific Committees : Dialogue and collaboration

12 July - 15 September 2010

Public consultation on the SCENIHR pre-consultation opinion on the Scientific Basis for a Definition of the Term "Nanomaterial"


Under : Scientific Committees : Dialogue and collaboration

09 July - 05 September 2010

Public consultation on the SCENIHR pre-consultation opinion on the Addictiveness and Attractiveness of Tobacco Additives


Under : Scientific Committees : Dialogue and collaboration

07 July - 08 September 2010

Call for information on the toxicity and the assessment of mixtures of chemicals


Under : Scientific Committees : Dialogue and collaboration

11 May - 02 July 2010

Call for Information on Health Effects of Artificial Light

 


Under : Scientific Committees : Dialogue and collaboration

13 April - 15 July 2010

Public consultation on the legal framework for veterinary medicinal products: "Better regulation of veterinary pharmaceuticals: how to put in place a simpler legal framework, safeguarding public and animal health while increasing the competitiveness of companies"

By means of this public consultation DG SANCO intends to consult all stakeholders. The paper provides a basis for discussion on key issues and key items where a need and/or possible amendments of the legal framework have already been identified by stakeholders. The purpose of the paper is not to outline detailed legal amendments.


Under : Pharmaceuticals

29 March - 26 May 2010

Public consultation on the SCCS preliminary opinion on the antimicrobial resistance effect of triclosan


Under : Scientific Committees : Dialogue and collaboration

05 March - 09 April 2010

Call for experts in behavioural psychology

Call for expression of interest for experts in behavioural psychology in relation to the work on potential health risks posed by food-imitating and child-appealing chemical consumer products


Under : Scientific Committees : Dialogue and collaboration

05 March - 12 April 2010

Public consultation on environmental and health effects posed by depleted uranium


Under : Scientific Committees : Dialogue and collaboration

17 December 2009 - 19 February 2010

Public Consultation - Towards a Strategic Nanotechnology Action Plan (SNAP) 2010-2015


Under : Nanotechnology

03 December 2009 - 04 January 2010

Public consultation on a working mandate for a scientific opinion on health effects of artificial light


Under : Dialogue and collaboration : Scientific Committees

30 November 2009 - 11 January 2010

Call for Information on the addictiveness and attractiveness of tobacco additives


Under : Dialogue and collaboration : Tobacco : Scientific Committees

05 November - 15 December 2009

Call for Information on the safety of reprocessed single-use medical devices


Under : Dialogue and collaboration : Scientific Committees

14 October - 09 December 2009

Consultation on the EU role in global health


Under : EU in the world

24 June 2009

Call for information on Mercury Sphygmomanometers in Healthcare and the Feasibility of Alternatives


Under : Dialogue and collaboration : Scientific Committees

27 May - 30 June 2009

Scientific Hearing on Nanotechnology - Launch of Public Consultation


Under : Scientific Committees : Nanotechnology : Dialogue and collaboration

25 May - 24 June 2009

Public Consultation on the Risk Assessment Advanced Training Programme (RAAP) Guidelines


Under : Scientific Committees : Dialogue and collaboration

18 March - 15 April 2009

Consultation: EU action to reduce health inequalities


Under : Social determinants and health inequalities

12 March - 10 April 2009

Public consultation on the Green Paper on the European Workforce for Health


Under : Health workforce

31 October - 30 November 2008

Public Consultation on the SCENIHR preliminary report on Effects of the Active Substances in Biocidal Products on Antibiotic Resistance


Under : Dialogue and collaboration : Scientific Committees : Antimicrobial resistance

25 March - 20 May 2008

Open Consultation on Patient Safety


Under : Patient safety

14 March 2008

Call for information on assessment of the Antibiotic Resistance Effects of Biocides


Under : Dialogue and collaboration : Scientific Committees : Antimicrobial resistance

28 February 2008

Call for information on phthalates in school supplies


Under : Dialogue and collaboration : Scientific Committees

31 January 2008

Call for information on risk Assessment methodologies and approaches for mutagenic and carcinogenic substances


Under : Dialogue and collaboration : Scientific Committees

Public Consultation on 'Working mandate': Phthalates in school supplies


Under : Dialogue and collaboration : Scientific Committees

02 January - 14 February 2008

Public Consultation regarding a European Action in the Field of Rare Diseases


Under : Rare diseases

03-28 September 2007

Public consultation on the SCENIHR preliminary report on "Health Effects of Smokeless Tobacco Products"


Under : Dialogue and collaboration : Tobacco : Scientific Committees

Public consultation on Green Paper on Bio-preparedness


Under : Preparedness and response

16 August - 06 September 2007

Public consultation on the SCCP preliminary report on "Safety of Nanomaterials in Cosmetic Products"


Under : Scientific Committees : Nanotechnology : Dialogue and collaboration

16 August - 06 September 2007

Public consultation on the SCCP preliminary report on "Sensitivity to Hair Dyes - Consumer Self Testing"


Under : Scientific Committees : Dialogue and collaboration

04 June 2007

Call for information on environmental risks and indirect health effects of mercury in dental amalgam


Under : Dialogue and collaboration : Scientific Committees

22 March - 03 April 2007

Public consultation on the SCHER preliminary report on Risk assessment on indoor air quality


Under : Scientific Committees : Healthy environments : Dialogue and collaboration

18 December 2006 - 31 January 2007

Consultation regarding Community action on health services


Under : Healthcare : Health workforce : Cross-border care

15 December 2006

Call for information on Health Safety of Nanomaterials in Cosmetic Products


Under : Dialogue and collaboration : Scientific Committees : Nanotechnology

03 October - 03 November 2006

Public consultation on the SCENIHR Opinion on Possible effects of Electromagnetic Fields (EMF) on Human Health


Under : Scientific Committees : Healthy environments : Electromagnetic fields : Dialogue and collaboration

12 May 2006

Call for information on Health Effects of Smokeless Tobacco Products


Under : Dialogue and collaboration : Tobacco : Scientific Committees

09 January - 10 February 2006

Public consultation: SCENIHR Opinion on The Safety of Human-derived Products with regard to Variant Creutzfeldt-Jakob Disease (vCJD)


Under : Dialogue and collaboration : Scientific Committees : Communicable diseases

17 November - 16 December 2005

Public consultation SCENIHR Opinion on How to Assess the Potential Risks of Nanotechnologies


Under : Dialogue and collaboration : Scientific Committees : Nanotechnology

19 May 2005

Open Consultation on Draft Technical Requirements for Tissues and cells


Under : Blood, tissues and organs

15 December 2004 - 31 January 2005

Public consultation on a preliminary opinion on hydrogen peroxide in tooth whitening products


Under : Dialogue and collaboration : Scientific Committees

15 September - 15 October 2004

Reflection process on EU health policy


Under : Health strategy

01 March - 01 April 2001

Consultation on the WHO Framework Convention on tobacco control


Under : Tobacco