Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
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.
Period of consultation
From 18 November 2011 to 27 April 2012.
Contributions to and results of the consultation
Please note that some contributors requested their responses not to be made public.
Below are the public responses to the above-mentioned public consultation:
- ABDA - Federal Union of German Associations of Pharmacists
- abpi - Association of the British Pharmaceutical Industry
- Actavis
- Aefi- Comisión de Normas de Correcta Fabricación
- Aegate
- Aemps - Spanish Agency of Medicinal Products
- AESEG - Asociación Española de Medicamentos Genéricos
- Aesgp - Association Européenne des Spécialités Pharmaceutiques Grand Public
- Agenzia Italiana del farmaco - Ministero della salute
- AIM - Association Internationale de la Mutualité
- Allergy Therapeutics Ltd.
- ANF
- ASSOGENERICI – Italian Generic Medicines Association
- Austrian Chamber of Pharmacists
- Baxter World Trade
- BCGA UK
- BEUC - The European Consumer Organisation
- BGMA - British Generic Manufacturers Association
- Blue Sphere small and medium size entreprise
- Bundesministerium für Gesundheit (Germany)
- BMA - British Medical Association
- BOGIN - Bond van de Generieke Geneesmiddelenindustrie Nederland
- BPI - Bundesverband der Pharmazeutischen Industrie : [1] - [2]
- Bundesamt für Sicherheit im Gesudheitswessen
- CDB - Centraal Bureau Drogisterijbedrijven
- COSTEFF - alliance for cost-efficiency in healthcare
- DOMINO - Domino Printing Sciences plc
- EAEPC - European Association of Euro-Pharmaceutical Companies
- EAHP - European Association of Hospital Pharmacist
- ECHAMP - European Coalition on Homeopathic and Anthroposophic Medicinal Products
- edqm - The European Department for the Quality of Medicines : [1] - [2]
- EFPIA – European Federation of Pharmaceutical Industries and Associations
- EFPIA-EAEPC-GIRP-PGEU
- EGA - European Generic medicines Association
- EHIBCC - European Health Industry Business Communications Council
- EIGA - European Industrial Gas Association : [1] - [2]
- EIPG - European Industrial Pharmacists Group
- England Specialist Pharmacy Services
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- EUSP - European Union of the Social Pharmacies
- Farmindustria
- FCIO - Chemische Industrie
- FIMEA
- FO Fotorotar AG
- FO-Security
- GALENpharma GmbH
- GE Healthcare
- GHP - Guild of Healthcare Pharmacists
- GIRP – European Association of Pharmaceutical Full-line Wholesalers
- GS1 facilitated working group
- GS1 Healthcare : [1] - [2]
- HOPE - European Hospital and Healthcare Federation, an international non-profit organisation
- IAA - International Authentication Association
- IFA GmbH - Informationsstelle für Arzneispezialitäten : [1] - [2]
- IGL - Danish Generic Medicines Industry Association
- IPFA - International Plasma Fractionation Association
- Max Pharma GmbH : [1] - [2]
- MiEF - Medicines in Europe Forum
- MHRA - Medicines and Healthcare products Regulatory Agency : [1] - [2]
- Ministry of health - Republic of latvia
- Ministry of Health, Welfare and Sport - Netherlands
- NHS - Pharmaceutical Quality Assurance Committee
- NHS European Office
- Norgine Ltd.
- NPSA - National Patient Safety Agency
- PGEU - Pharmaceutical Group of the European Union : [1] - [2]
- PHAGRO - Association of Pharmaceutical Full-line Wholesalers in Germany
- PHARMIG - Association of the Austrian pharmaceutical industry
- Pharmaceutical Society of Nothern Ireland
- Pro Generika e.V. - German Association of Generic Manufacturers
- Représentation permanente de la France auprès de l'Union Européenne
- Royal Pharmaceutical Society
- Sanofi - Aventis
- SECURIKETT
- Securikett Ulrich & Horn GmbH
- Leonhard Kurz Stiftung & Co.KG
- Brainority Software GmbH
- securPharm
- Shire Pharmaceuticals
- Solgar UK Ltd
- State Institute for Drug Control - czech Republic
- Teva Pharmaceuticals Europe B.V.
- Vesdo
Targeted stakeholders
All citizens and organisations are welcome to contribute to this consultation.
Objective of the consultation
Directive 2011/62/EU to fight against falsified medicines 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.
The consultation document
The consultation document can be downloaded here.
Protection of personal data
The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.