Responses to the public consultation on the concept paper on the detailed rules for a unique identifier for medicinal product for human use

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 enclosed concept paper(93 KB) has been launched for public consultation until 27 April 2012 with a view to preparing both the impact assessment and the delegated act


Below are the public responses to the above mentioned concept paper.

• ABDA - Federal Union of German Associations of Pharmacists(141 KB)
• abpi - Association of the British Pharmaceutical Industry(67 KB)
• Actavis(51 KB)
• Aefi- Comisión de Normas de Correcta Fabricación(15 KB)
• Aegate(180 KB)
• Aemps - Spanish Agency of Medicinal Products(2 MB)
• AESEG - Asociación Española de Medicamentos Genéricos(311 KB)
• Aesgp - Association Européenne des Spécialités Pharmaceutiques Grand Public (553 KB)
• Agenzia Italiana del farmaco - Ministero della salute(61 KB)
• AIM - Association Internationale de la Mutualité(37 KB)
• Allergy Therapeutics Ltd.(18 KB)
• ANF(110 KB)
• ASSOGENERICI – Italian Generic Medicines Association(543 KB)
• Austrian Chamber of Pharmacists(219 KB)
• Baxter World Trade(661 KB)
• BCGA UK(54 KB)
• BEUC - The European Consumer Organisation(137 KB)
• BGMA - British Generic Manufacturers Association(441 KB)
• Blue Sphere small and medium size entreprise(208 KB)
• Bundesministerium für Gesundheit (Germany)(20 KB)
• BMA - British Medical Association(51 KB)
• BOGIN - Bond van de Generieke Geneesmiddelenindustrie Nederland(5 MB)
• BPI - Bundesverband der Pharmazeutischen Industrie 1(26 KB) - 2(105 KB)
• Bundesamt für Sicherheit im Gesudheitswessen(460 KB)
• CDB - Centraal Bureau Drogisterijbedrijven(75 KB)
• COSTEFF - alliance for cost-efficiency in healthcare(3 MB)
• DOMINO - Domino Printing Sciences plc(139 KB)
• EAEPC - European Association of Euro-Pharmaceutical Companies(180 KB)
• EAHP - European Association of Hospital Pharmacist(170 KB)
• ECHAMP - European Coalition on Homeopathic and Anthroposophic Medicinal Products(51 KB)
• edqm - The European Department for the Quality of Medicines 1(213 KB) - 2(348 KB)
• EFPIA – European Federation of Pharmaceutical Industries and Associations(345 KB)
• EFPIA-EAEPC-GIRP-PGEU(603 KB)
• EGA - European Generic medicines Association(575 KB)
• EHIBCC - European Health Industry Business Communications Council(514 KB)
• EIGA - European Industrial Gas Association 1(53 KB) - 2 (10 KB)
• EIPG - European Industrial Pharmacists Group(24 KB)
• England Specialist Pharmacy Services(56 KB)
• EUCOPE - European Confederation of Pharmaceutical Entrepreneurs(305 KB)
• EUSP - European Union of the Social Pharmacies (213 KB)
• Farmindustria(157 KB)
• FCIO - Chemische Industrie(152 KB)
• FIMEA(341 KB)
• FO Fotorotar AG(77 KB)
• FO-Security(657 KB)
• GALENpharma GmbH(91 KB)
• GE Healthcare(350 KB)
• GHP - Guild of Healthcare Pharmacists(101 KB)
• GIRP – European Association of Pharmaceutical Full-line Wholesalers(774 KB)
• GS1 facilitated working group(138 KB)
• GS1 Healthcare 1(105 KB) - 2(172 KB)
• HOPE - European Hospital and Healthcare Federation, an international non-profit organisation(36 KB)
• IAA - International Authentication Association(100 KB)
• IFA GmbH - Informationsstelle für Arzneispezialitäten 1(748 KB) - 2(389 KB)
• IGL - Danish Generic Medicines Industry Association(236 KB)
• IPFA - International Plasma Fractionation Association(34 KB)
• Max Pharma GmbH 1(27 KB) - 2(197 KB)  Deutsch (de)
• MiEF - Medicines in Europe Forum(395 KB)
• MHRA - Medicines and Healthcare products Regulatory Agency 1(197 KB) - 2(75 KB)
• Ministry of health - Republic of latvia(147 KB)
• Ministry of Health, Welfare and Sport - Netherlands(234 KB)
• NHS - Pharmaceutical Quality Assurance Committee(60 KB)
• NHS European Office(177 KB)
• Norgine Ltd.(161 KB)
• NPSA - National Patient Safety Agency(90 KB)
• PGEU - Pharmaceutical Group of the European Union 1 (238 KB)- 2(555 KB)
• PHAGRO - Association of Pharmaceutical Full-line Wholesalers in Germany(511 KB)
• PHARMIG - Association of the Austrian pharmaceutical industry(245 KB)
• Pharmaceutical Society of Nothern Ireland(170 KB)
• Pro Generika e.V. - German Association of Generic Manufacturers(147 KB)
• Représentation permanente de la France auprès de l'Union Européenne  français (fr)
• Royal Pharmaceutical Society(237 KB)
• Sanofi - Aventis(462 KB)
• SECURIKETT(770 KB)
  • Securikett Ulrich & Horn GmbH
  • Leonhard Kurz Stiftung & Co.KG
  • Brainority Software GmbH
• securPharm(487 KB)
• Shire Pharmaceuticals(281 KB)
• Solgar UK Ltd(20 KB)
• State Institute for Drug Control - czech Republic(165 KB)
• Teva Pharmaceuticals Europe B.V.(164 KB)
• Vesdo(707 KB)

 

Some contributors requested their responses not to be made public.

 

• Falsified medicines - Major developments