Article 50 Report 2010

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Report to the European Commission Companies and products that have benefited from any of the rewards and incentives in the paediatric regulation and the companies that have failed to comply with any of the obligations in this regulation covering the years 2007 to 2009
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   7 Westferry Circus ● Canary Wharf  ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged. 27 April 2010EMA/50813/2009Human Medicines Development and Evaluation Report to the European Commission Companies and products that have benefited from any of the rewards andincentives in the paediatric regulation and the companies that have failed tocomply with any of the obligations in this regulation covering the years 2007to 2009 Prepared by the Section Paediatric MedicinesHuman Medicines Special Areas SectorEuropean Medicines Agency   Report to the European CommissionEMA/50813/2009 Page 2/34  Table of contents 1.   INTRODUCTION.....................................................................................4   1.1. Scope of the report...............................................................................................4   1.2. Data collection.....................................................................................................4   1.3. Overview of the implementation of the Paediatric Regulation.....................................5   2. COMPANIES AND PRODUCTS THAT HAVE BENEFITED FROM ANY OF THEREWARDS AND INCENTIVES IN THE REGULATION......................................6   2.1. Scientific advice...................................................................................................6   2.1.1. Advice from the Agency......................................................................................6   2.1.2. Advice from the National Competent Authorities....................................................7   2.2. Paediatric Investigation Plans – Waiver...................................................................7   2.3. Compliance statement included in a marketing authorisation.....................................9   2.3.1. Compliance statement for centrally-authorised medicinal products...........................9   2.3.2. Compliance statement for medicinal products authorised throughnational/decentralised/mutual recognition procedure, including those subject to Article 29 of the Paediatric Regulation.............................................................................................9   2.4. Extension of the Supplementary Protection Certificate/Market Exclusivity..................10   2.5. Marketing authorisation granted or varied with mention of the waiver or deferral in theSummary of Product Characteristics............................................................................10   2.6. Price/reimbursement benefits..............................................................................12   2.7. Research incentives............................................................................................12   2.7.1. EU Framework Programme...............................................................................12   2.7.2. European Network of Paediatric Research at the European Medicines Agency..........12   2.7.3. National initiatives...........................................................................................13   2.8. Authorisation of paediatric clinical trials.................................................................15   2.9. Procedures for marketing authorisation.................................................................15   2.10. Article 45/46 of the Paediatric Regulation............................................................17   2.10.1. Article 45......................................................................................................17   2.10.2. Article 46......................................................................................................17   3. FAILURE TO COMPLY WITH THE OBLIGATIONS SET IN THE PAEDIATRICREGULATION.............................................................................................19   3.1. Submissions of the PIP/waiver application to the PDCO...........................................19   3.2. Validation of application for marketing authorisation/extension................................19   3.3. Compliance with the paediatric requirements and rewards.......................................20   3.4. Mention of the Decision on waivers or deferrals in the product information................20   3.5. Annual reports on deferrals.................................................................................20     Report to the European CommissionEMA/50813/2009 Page 3/34  4. CONCLUSION.........................................................................................20   Annex 1 - Questions sent to the Member States........................................22   Annex 2 - Compliance statement included in a marketing authorisation forproducts authorised through national/decentralised/mutual recognitionprocedure..................................................................................................24   Annex 3 - 6-months extension of the supplementary protection certificate(SPC) granted by the National Patent Office.............................................28   Annex 4 – List of projects on off-patent medicines funded by the EuropeanCommission through the EU Framework Programme.................................31   Annex 5 - List of products and resulting amendment of the SmPC further tosubmission of data through article 45 and 46............................................32     Report to the European CommissionEMA/50813/2009 Page 4/34  1. INTRODUCTION 1.1. Scope of the report  Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on medicinal productsfor paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive2001/83/EC and Regulation (EC) No 726/2004 (hereinafter 'the Paediatric Regulation') was adopted on12th December 2006. It was published in the Official Journal of the European Communities on 27thDecember 2006 and entered into force on 27th January 2007.Article 50(1) states : “On the basis of a report from the Agency, and at least on an annual basis, theCommission shall make public a list of the companies and of the products that have benefited from anyof the rewards and incentives in this Regulation and the companies that have failed to comply with anyof the obligations in this Regulation. The Member States shall provide this information to the Agency.”  Considering the early days of the implementation of the Paediatric Regulation and the lack of internalresources, the European Medicines Agency (hereafter “the Agency”) was not able to produce such areport for the years 2007 and 2008. This report therefore covers the whole period from the entry intoforce of the Paediatric Regulation, i.e. 26 January 2007 to 31 December 2009.As explicitly requested, this report lists the companies and products that have benefited from any of the rewards and incentives defined in this Regulation both at the European Union and at national level.The report examines also the situation where companies would have failed to comply with any of theobligations set in this Regulation. The figures reported correspond to procedures with the start datewithin the year.Incentives available at EU level are supported by complementary national initiatives, particularly inareas such as fiscal incentives and national research projects. Pursuant to Article 39(2) of thePaediatric Regulation, the European Commission published such inventory on national measures basedon information received from 18 of 27 Member States on 30 July 2008. 1.2. Data collection  The Agency sent a letter on 10 December 2009 to all Member States to require contributions toprepare this report (Letter sent to Permanent Representatives of the Member States of the EuropeanUnion with a response requested by 31 January 2010). The letter contained a list of information to beprovided (Annex 1).We also contacted the DG Research to obtain information on the projects funded through theframework programme in the context of the Paediatric Regulation.The Agency also sent a copy of this letter to the Heads of Agencies and informed the CoordinationGroup for Mutual Recognition and Decentralised Procedure – human, accordingly. In order to obtainthe highest return rate, a reminder was sent on 11 February 2010.The Agency received feedback from 22 Member States:Austria- Belgium - Bulgaria – Czech Republic - Cyprus – Denmark - Estonia – France - Finland –Germany – Hungary - Ireland – Italy – Latvia – Lithuania – Luxembourg – Malta - The Netherlands -Romania - Slovak Republic - Slovenia – Sweden - United Kingdom.No answer has been received from Greece – Poland - Portugal – Spain.Information was also received from EFTA States. The Paediatric Regulation is not yet part of the EEAAgreement and therefore is not yet implemented in EFTA States (Iceland, Liechtenstein and Norway).
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