Zulassungsdublette / Dublettenverfahren
English translation: duplicate marketing authorisation application / duplicate marketing authorisation procedure
| 10:51 Jul 10, 2015 |
| German to English translations [PRO] Medical - Medical: Health Care / marketing strategy paper | |||||
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|  Selected response from: andres-larsen Venezuela Local time: 09:32 | ||||
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| Dublettenverfahren |
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| Approval of a biological medicinal product within the Mutual Recognition Procedure |
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| Discussion entries: 2 | |
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Answers
4 hrs confidence: 
peer agreement (net): +1
peer agreement (net): +1duplicate marketing authorisation application / duplicate marketing authorisation procedure Explanation: duplicate marketing authorisation application / duplicate marketing authorisation procedure sources: Handling of duplicate marketing authorisations applications ec.europa.eu/health/files/latest_news/2011_09_upd.pdf Oct 3, 2011 - The requests for duplicate marketing authorisations under Article 82(1) of ... marketing authorisations granted under the centralised procedure, ... Chapter 2 - Mutual Recognition - European Commission ec.europa.eu/health/files/eudralex/vol-2/.../vol2a_chap2_2007-02_en.pdf granted or an application assessed by the reference Member State it can ..... authorisations, “national duplicates” of nationally authorised medicinal products in. Types of marketing authorisation - Taylor Wessing www.taylorwessing.com/synapse/regulatory_type.html Applications are made directly to the European Medicines Agency (the "EMA") ... One member state (the "Reference Member State") will decide to evaluate the ... reasons, ***a company wishes to make a duplicate of a marketing authorisation***. Ordinance concerning fees for the governmental control of ... https://lakemedelsverket.se/.../SFS_2010-1_EN1 reviderad 201... Medicinal product approved by the support of a duplicate application and which .... c) duplicate application (both in Sweden and the concerned member states). CMD(h) www.hma.eu/uploads/media/rec_multiapp.pdf legally not acceptable for a Concerned Member State (CMS) to recognise more ... subsequent duplicate applications in another Member State of the EEA has to ... Agreement on Sunset Clause - Heads of Medicines Agencies www.hma.eu/uploads/media/Sunset_clause_Duplicates.pdf AUTHORISATIONS GRANTED IN MORE THAN ONE MEMBER STATE. December ... The above mentioned definition concerns an application for a duplicate. CMD(h) www.hma.eu/uploads/media/rec_multiapp.pdf AND DECENTRALISED PROCEDURES. May 1999. Revision ... Applications for duplicates result in independent marketing authorisations which can be varied. Heads of Medicines Agencies: Application for MA www.hma.eu/91.html Application for Marketing Authorisation ( MA ) ... Best Practice Guide for the Decentralised and Mutual Recognition Procedures (April 2013) [Track version] ... Recommendations on Multiple/Duplicate Applications in Mutual Recognition and ... Agreement on Sunset Clause - Heads of Medicines Agencies www.hma.eu/uploads/media/Sunset_clause_Duplicates.pdf and Decentralised Procedures - Human. Co-ordination ... followed by the actual placing on the market of the authorised product in the authorising. Member ... A definition of a duplicate (multiple application, copy) is lacking in pharmaceutical. in German: BfArM - Dubletten www.bfarm.de/DE/.../zul/.../Dubletten/_node.html Formblatt zur Einreichung von nationalen Dubletten zu Arzneimitteln, die über das ... on multiple/duplicate applications..., Abschnitt 2 "the duplicate application is ... pertinent explanatory extract from above official German source: Hinweis zur Einreichung nationaler Parallelanträge mit DE = CMS Wurde die Basiszulassung in einem EU-Verfahren mit Deutschland als "Concerned Member State (CMS)" erteilt, ist kein Dublettenantrag möglich (siehe Notice to Applicants (NTA), Vol. 2A Ch.2, P 3.2 “Procedure leading to mutual recognition” sowie CMDh-Empfehlung „Recommendations on multiple/duplicate applications..., Abschnitt 2 "the duplicate application is submitted in a Concerned Member State")“. |
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duplicate marketing authorisation application/duplicate application [procedure] Explanation: Article 82(1) requires that the duplicate marketing authorisation application is for “that medicinal product”. This should be seen in connection with the previous subparagraph which reads “Only one authorisation may be granted to an applicant for a specific medicinal product”. This means that the duplicate marketing authorisation has to refer to the specific medicinal product covered by the original marketi ng authorisation/application (as it stands at the time of submitting the duplicate mark eting authorisation application). http://ec.europa.eu/health/files/latest_news/duplicates_note... Applications for marketing authorisations, including duplicates, are submitted to the European Medicines Agency. In connection with the validation of a duplicate marketing authorisation, the following elements should be checked by the Agency: - That the duplicate application is submitted by the same applicant that has submitted the marketing authorisation/application that is being duplicated (hereafter “original marketing authorisation/application”). Further clarifications of this requirement are laid down in Section C.1. ... http://ec.europa.eu/health/files/latest_news/2011_09_upd.pdf The Commission allowed duplicate applications from companies with the same ownership but placed restrictions on, for example, the use of different drug names, manufacturing sites, and excipients. Now the number of generic-drug and hybrid-drug applications under the centralized system has dropped by more than half since the restrictions were introduced. In 2013, they totalled 20 against 45 in 2011. http://www.pharmtech.com/harmonizing-marketing-approval-gene... Zulassung nationaler identischer Anträge zu bereits zugelassenen Arzneimitteln (sog. Dublettenverfahren) Nationale Zulassungsanträge nach § 21 bzw. § 24b AMG für Arzneimittel, die identisch zu bereits nach § 25 Abs. 1 AMG zugelassenen Arzneimitteln sind, können als sog. Dublettenanträge eingereicht werden. Die beschleunigte Bearbeitung dieser Anträge in einem "Vereinfachten Verfahren" ist unter bestimmten Voraussetzungen möglich. http://www.bfarm.de/DE/Arzneimittel/zul/zulassungsverfahren/... |
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Reference comments
16 mins |
| Reference: Dublettenverfahren Reference information: http://www.bfarm.de/DE/Arzneimittel/zul/zulassungsverfahren/... Reference: http://www.bfarm.de/DE/Arzneimittel/zul/zulassungsverfahren/... |
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2 hrs |
| Reference: Approval of a biological medicinal product within the Mutual Recognition Procedure Reference information: Download Master-Thesis (PDF, 755 KB) - DGRA dgra.de/media/pdf/studium/masterthesis/master_kempny_k.pdf Approval of a biological medicinal product within the Mutual Recognition Procedure (RMS: Germany) – regulatory strategies and potential challenges. 11 Wissenschaftliche Prüfungsarbeit zur Erlangung des ... www.abstract.lib-ebook.com/.../1312245-11-wissenschaftliche... 11 Approval of a biological medicinal product within the Mutual Recognition Procedure ... November BfArM: ―Hinweise zum nationalen Dublettenverfahren‖, ... -------------------------------------------------- Note added at 2 hrs (2015-07-10 13:06:47 GMT) -------------------------------------------------- BfArM - Dubletten www.bfarm.de/DE/Arzneimittel/zul/.../_node.html Die Bearbeitung im nationalen Dublettenverfahren ist im Anschreiben zu beantragen. ... 2A Ch.2, P 3.2 “Procedure leading to mutual recognition” sowie CMDh ... Heads of Medicines Agencies: Medicines Approval system www.hma.eu/medicinesapprovalsystem.html These routes determine the procedures, processes and timelines used in ... The mutual recognition procedure ( MRP ) is a European authorisation route ... The Mutual Recognition Procedure - European Commission ec.europa.eu/health/authorisation-procedures-mutual-recognition_en.htm Jun 25, 2015 - European Commission - Basic arrangements for implementing the mutual recognition procedure laid down in Directive 2001/83/EC have been ... What is mutual recognition? - European Commission ec.europa.eu/justice/data...rules/mutual_recognition/index_en.htm In order to speed up the EU procedure of cooperation for the BCR review by data protection authorities, a mutual recognition procedure has been agreed. Chapter 2 - Mutual Recognition - European Commission ec.europa.eu/health/files/eudralex/vol-2/.../vol2a_chap2_2007-02_en.pdf The legal provisions covering the mutual recognition procedure and the decentralised procedure for human medicinal products are contained in Directive ... -------------------------------------------------- Note added at 2 hrs (2015-07-10 13:07:41 GMT) -------------------------------------------------- zulassungs medizin.freepage.de/schweim/Ggb62.pdf Gesetzliche Grundlagen (seit 01.10.2003). Variations. Gesetzliche Grundlagen (seit 01.10.2003). Mutual Recognition Procedure. Commission Regulation (EC) ... -------------------------------------------------- Note added at 2 hrs (2015-07-10 13:08:04 GMT) -------------------------------------------------- zulassungs medizin.freepage.de/schweim/Ggb62.pdf Gesetzliche Grundlagen (seit 01.10.2003). Variations. Gesetzliche Grundlagen (seit 01.10.2003). Mutual Recognition Procedure. Commission Regulation (EC) ... |
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