Medicinal products for human use
Public consultation on the concept paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency
Period of consultation
From 19 June 2012 to 15 September 2012.
Contributions to and results of the consultation
A summary of the responses is available here.
The following submitting parties requested their submission not to be published: C. Brady (Austria), Combe International Ltd., Dallas Burston Ashbourne Ltd., Derma UK, Four Pharmaceuticals Ltd. (UK), Greek National Agency Organization (EOF), Romastru Trading SRL, S.A. MITHRA Pharmaceuticals NV and SpePharm Holding BV.
Below are the public responses to the above-mentioned public consultation:
- ABPI - Assocation of the British Pharmaceutical Industry
- ACTAVIS Group
- ADIENNE S.r.l.
- AEFI - Spanish Association of Pharmacists in industry
- AEMPS - Spanish Agency of Medicines and Medical Devices
- AESGP - Association of the European Self-Medication Industry
- AGEPHA GmbH
- AGES Medizinmarktaufsicht / Austrian Medicines and Medical Devices Agency
- Allergy Therapeutics plc.
- APREFAR - Association of Regulatory Affairs and Pharmaceutical Regulation Professionals
- ARDEZ Pharma, s.r.o.
- Auden Mckenzie (Pharma Division) Ltd.
- Aurobindo Pharma Limited
- Bene Farmacêutica, Lda. (Affiliate of Bene Arzneimittel GmbH)
- Bogin - Association of the Dutch Generic Medicines Industry
- BPI - German Pharmaceutical Industry Association
- Danish Health and Medicines Authority
- Daquimed SA
- Dr Reddy's Laboratories Ltd. (UK)
- Dr. Peithner KG nunmehr GmbH & Co
- EAMG - European Allergen Manufacturers Group
- EATG - European AIDS Treatment Group
- ECHAMP - European Coalition on Homeopathic and Anthroposophic Medicinal Products
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EGA - European Generic Medicines Association
- Eifelfango GmbH & Co. KG
- EIGA - European Industrial Gases Association
- EQL Pharma AB
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- European Federation of Allergy and Airways Diseases Patients' Associations
- EURORDIS - European Organisation for Rare Diseases
- Farmindustria - Italian Association of Pharmaceutic Enterprises
- FCIO - Association of Chemical Industry of Austria
- Gebro Pharma GmbH
- Gilead Sciences International Limited
- HAI Europe - Health Action International / ISDB - International Society of Drug Bulletins / MiEF - Medicines in Europe Forum
- HMA - Heads of Medicines Agency Management Group
- IGOR - Institut fuer Gewebe- und Organrekonstruktion GmbH
- Irish Medicines Board
- Kappler Pharma Consult GmbH
- Laboratoire BIOGARAN
- LABORATÓRIO EDOL, Produtos Farmacêuticos S.A.
- Lionpharm Regulatory Consulting
- Manx Healthcare Ltd
- Maurizio Schiassi - Consultant for PhV
- Medical Products Agency (Sweden)
- Medicines Evaluation Board (the Netherlands)
- MHRA - Medicines and Healthcare Products Regulatory Agency / United Kingdom Government
- Marian Verbruggen, Drug Safety Officer, generic company in the Netherlands
- Norwegian Medicines Agency
- PAGB - Proprietary Association of Great Britain
- PEI - Paul-Ehrlich-Institut / BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
- PFIZER Ltd.
- Pharma Liebermann GmbH (Germany)
- Pharma Schwoerer GmbH
- Pharmathen S.A. (Greece)
- PHARMIG, FOPI, IGEPHA and Federal Association of Wholesalers and Retailers (Austria)
- Pharmis Biofarmacêutica, Lda. & Color Pharma, Lda.
- Phönix Laboratorium GmbH
- PIPA - Pharmaceutical Information and Pharmacovigilance Association
- POLFARMED - Polish Chamber of Pharmaceutical Industry and Medical Devices
- PPTA - Plasma Protein Therapeutics Association
- Pro Generika e.V. - German Association of Generic Manufacturers
- Santen Oy
- Scope Ophthalmics
- SmartPractice Denmark ApS
- Strandhaven Ltd. (UK)
- Susanne Riel - AGEPHA GmbH
- Tender Corporation
- Teva Pharmaceuticals Europe BV
- Weleda Ges.m.b.H & Co.KG
Objective of the consultation
The new pharmacovigilance legislation Regulation (EU) No 1235/2010 of 15.12.2010 and Directive 2010/84/EU of 15.12.2010 (OJ 31.12.2010, L348) enables the European Medicines Agency to charge fees for its new pharmacovigilance activities. With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on the proposed structure and levels of fees for pharmacovigilance.
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.