European Commission
Public Health

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

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

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

Public consultation on advanced therapy medicinal products

Stakeholders are invited to provide their views on the application of the Advanced Therapy Regulation at SANCO-ADVANCEDTHERAPY-REPORT@ec.europa.eu.
More information here

Public consultation on post-authorisation efficacy studies

Under : Medicinal products for human use

Public consultation on the implementation of European Reference Networks (ERN) under the framework of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare

Under : Rare diseases : Cross-border care

Public consultation on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring

Under : Medicinal products for human use

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

Under : Scientific Committees

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.

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

Under : Healthcare

Public consultation on the delegated act on the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products

Under : Medicinal products for human use

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

Under : Scientific Committees

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

Under : Scientific Committees

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

Under : Scientific Committees

Call for experts on medical devices containing nanomaterials

Under : Scientific Committees

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

Under : Scientific Committees

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

Under : Scientific Committees

Call for information on the safety of medical devices containing DEHP [di(2-ethylhexyl) phthalate

Under : Scientific Committees

Call for information on the safety of medical devices containing nanomaterials

Under : Scientific Committees

Call for information on the safety of metal-on-metal joint replacements with a particular focus on hip implants

Under : Scientific Committees

Call for experts on metal-on-metal hip implants

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

Call for experts in EMF

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

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]

Public Consultation Paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency

Under : Medicinal products for human use

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

Under : Medicinal Products for Veterinary Use : Medicinal products for human use

Public consultation on the modalities of stakeholder consultation in the voluntary Health Technology Assessment network to be established under Directive 2011/24/EU

Under : Health technology assessment

Draft template for the written confirmation for active substances imported into the European Union for medicinal products for human use

Public consultation

Call for information on nanosilver: safety, health and environmental effects and role in antimicrobial resistance

Under : Scientific Committees

Invitation to provide input to the Chronic Disease reflection process

Additional information: Questionnaire addressed to stakeholders

Call for information on safety of bisphenol A in medical devices

Under : Scientific Committees

Call for Information on the safety of oxidative hair dye substances and hydrogen peroxide in products to colour eyelashes

Under : Scientific Committees

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.

Public consultation on the preliminary opinion concerning Improvement of Risk Assessment in View of the Needs of Risk Managers

Under : Scientific Committees

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

Under : Scientific Committees

Public consultation on the preliminary opinion on Nitrosamines and Secondary Amines in Cosmetic Products

Under : Scientific Committees

Public consultation on the request for a scientific opinion on the potential health effects of exposure to electromagnetic fields (EMF) and call for information

Under : Scientific Committees

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.

Call for information on the health effects of security scanners for passenger screening (based on X-ray technology)

Under : Scientific Committees

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.

Public consultation on measures for improving the recognition of prescriptions issued in another Member State

Under : Cross-border care

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

Public consultation on the preliminary opinion concerning the Health Effects of Artificial Light

Under : Scientific Committees

Public consultation on the preliminary opinion concerning Toxicity and Assessment of Chemical Mixtures

Under : Scientific Committees

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.

Stakeholder consultation on health security in the European Union

Under : Preparedness and response

Public consultation on technical aspects of the revision of the In Vitro Diagnostic medical device Directive

Public consultation outcome

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.

Public consultation on the SCCS pre-consultation opinion on the potential health risks posed by Chemical consumer products resembling food and/or having child-appealing properties

Under : Scientific Committees

Public Consultation on the pilot European Innovation Partnership on Active and Healthy ageing

Under : Ageing

Stakeholder Consultation on the Transatlantic Task Force on antimicrobial resistance

Under : Antimicrobial resistance

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

Under : Health and structural funds

Meeting with stakeholders on the study "Assessing the Impacts of Revising the Tobacco Products Directive" prepared by RAND Europe

Under : Tobacco

Public consultation on the possible revision of the Tobacco Products Directive 2001/37/EC

Under : Tobacco

Qualification of hygienic tampons containing lactic acid producing baceria

Public Consultation outcome

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.

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

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

Under : Scientific Committees : Dialogue and collaboration

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

Under : Scientific Committees : Dialogue and collaboration

Public consultation on the preliminary opinion concerning the critical review of any new evidence on the hazard profile, health effects, and human exposure to fluoride and the fluoridating agents of drinking water

Under : Scientific Committees

Stakeholder Consultation on Strengthening European Union Preparedness on Pandemic Influenza

Under : Preparedness and response

Call for Information on Health Effects of Artificial Light

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.

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

Under : Scientific Committees : Dialogue and collaboration

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

Public consultation on environmental and health effects posed by depleted uranium

Under : Scientific Committees : Dialogue and collaboration

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

Under : Nanotechnology

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

Under : Dialogue and collaboration : Scientific Committees

Call for Information on the addictiveness and attractiveness of tobacco additives

Under : Dialogue and collaboration : Tobacco : Scientific Committees

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

Under : Dialogue and collaboration : Scientific Committees

Consultation on the EU role in global health

Under : EU in the world

Call for the submission of data or other information on potential health risks posed by food-imitating and child-appealing chemical consumer products

Under : Dialogue and collaboration : Scientific Committees

2nd public call for the submission of new information or data on the hazard profile, health effects, and human exposure to fluoride and information and data on the health risks that may be associated with the use of most common drinking water fluoridation agents like silicofluorides (e.g. (hydro)fluorosilicic acid, sodium silicofluoride).

Under : Dialogue and collaboration : Scientific Committees

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

Under : Dialogue and collaboration : Scientific Committees

Scientific Hearing on Nanotechnology - Launch of Public Consultation

Under : Scientific Committees : Nanotechnology : Dialogue and collaboration

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

Under : Scientific Committees : Dialogue and collaboration

Call for information on the hazard profile, health effects, and human exposure to fluoride and information and data on the health risks that may be associated with the use of most common drinking water fluoridation agents like silicofluorides (e.g. (hydro)fluorosilicic acid, sodium silicofluoride).

Under : Dialogue and collaboration : Scientific Committees

Consultation: EU action to reduce health inequalities

Under : Social determinants and health inequalities

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

Under : Health workforce

Public Consultation on SCHER 'working mandate': The hazard profile, health effects, and human exposure to fluoride and information and data on the health risks that may be associated with the use of most common drinking water fluoridation agents like silicofluorides (e.g. (hydro)fluorosilicic acid, sodium silicofluoride)

Under : Dialogue and collaboration : Scientific Committees

Public consultation on the SCCP/SCHER/SCENIHR preliminary report on the "Use of the Threshold of Toxicological Concern (TTC) Approach for the Safety Assessment of Chemical Substances"

Under : Scientific Committees : Dialogue and collaboration

Public Consultation on the SCHER preliminary report on Risk assessment methodologies and approaches for mutagenic and carcinogenic substances

Under : Scientific Committees : Dialogue and collaboration

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

Public Consultation on the SCENIHR preliminary report on Potential health risks of exposure to noise from personal music players and mobile phones including a music playing function

Under : Scientific Committees : Population groups : Dialogue and collaboration

Call for information on the need for non-human primates in biomedical research, production and testing of products and devices

Under : Dialogue and collaboration : Scientific Committees

Public Consultation on SCHER 'Working mandate': The need for non-human primates in biomedical research, production and testing of products and devices

Under : Dialogue and collaboration : Scientific Committees

Open Consultation on Patient Safety

Under : Patient safety

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

Under : Dialogue and collaboration : Scientific Committees : Antimicrobial resistance

Call for information on phthalates in school supplies

Under : Dialogue and collaboration : Scientific Committees

Call for information on the use of the Treshold of Toxicological Concern (TTC) approach for the safety assessment of chemicals

Under : Dialogue and collaboration : Scientific Committees

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

Call for information on potential health risks of exposure to noise from personal music players and mobile phones including a music playing function

Under : Dialogue and collaboration : Scientific Committees

Public consultation on the SCENIHR preliminary report on "The safety of dental amalgam and alternative dental restoration materials for patients and users"

Under : Scientific Committees : Dialogue and collaboration

Public consultation on the SCHER preliminary report on "The environmental risks and indirect health effects of mercury in dental amalgam"

Under : Scientific Committees : Dialogue and collaboration

Public Consultation on 'Working mandate': the use of the Treshold of Toxicological Concern (TTC) approach for the safety assessment of chemicals

Under : Dialogue and collaboration : Scientific Committees

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

Under : Rare diseases

Public Consultation on 'Working mandate': Risk Assessment methodologies and approaches for mutagenic and carcinogenic substances

Under : Dialogue and collaboration : Scientific Committees

Public consultation on the SCENIHR preliminary report on "Safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk"

Under : Scientific Committees : Dialogue and collaboration

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

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

Under : Scientific Committees : Nanotechnology : Dialogue and collaboration

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

Under : Scientific Committees : Dialogue and collaboration

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

Under : Dialogue and collaboration : Scientific Committees

Call for information on the safety of dental amalgam and alternative dental restoration materials for patients and users

Under : Dialogue and collaboration : Scientific Committees

Call for the submission of safety data made available after 15 March 2005 on the use of hydrogen peroxide, in its free form or when released, in oral hygiene products

Under : Dialogue and collaboration : Scientific Committees

Public consultation SCENIHR Opinion on the appropriateness of the risk assessment methodology in accordance with the Technical Guidance Documents for new and existing substances for assessing the risks of nanomaterials

Under : Dialogue and collaboration : Scientific Committees

Consultation on the Green Paper "Towards a Europe free from tobacco smoke: policy options at EU level"

Under : Tobacco

High Level Pharmaceutical Forum Public consultation on Health-related information to patients

Under : Pharmaceuticals

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

Under : Scientific Committees : Healthy environments : Dialogue and collaboration

Consultation regarding Community action on health services

Under : Healthcare : Health workforce : Cross-border care

Call for information on Health Safety of Nanomaterials in Cosmetic Products

Under : Dialogue and collaboration : Scientific Committees : Nanotechnology

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

Call for information on Health Effects of Smokeless Tobacco Products

Under : Dialogue and collaboration : Tobacco : Scientific Committees

Call for information on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk

Under : Dialogue and collaboration : Scientific Committees

European Commission Green paper 'Promoting the Mental Health of the Population. Towards a Strategy on Mental health for the European Union'

Under : Mental health

Public consultation: SCCP Opinion on biological effects of ultraviolet radiation relevant to health with particular reference to sun beds for cosmetic purposes

Under : Dialogue and collaboration : Scientific Committees

European Commission Green paper "Promoting healthy diets and physical activity: a European dimension for the prevention of overweight, obesity and chronic diseases"

Under : Nutrition and physical activity

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

Open consultation on improving patient safety by prevention and control of healthcare-associated infections

Under : Patient safety

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

Under : Dialogue and collaboration : Scientific Committees : Nanotechnology

Open Consultation on Draft Technical Requirements for Tissues and cells

Under : Blood, tissues and organs

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

Under : Dialogue and collaboration : Scientific Committees

Reflection process on EU health policy

Under : Health strategy

Open Consultation on 'Technical requirements for the donation procurement and testing of human tissues and cells'

Under : Blood, tissues and organs

Survey on the thematic web site on public health

Under