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Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 1 Principles of Article 58 - possible support to 3rd countries for licensing.

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Presentation on theme: "Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 1 Principles of Article 58 - possible support to 3rd countries for licensing."— Presentation transcript:

1 Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 1 Principles of Article 58 - possible support to 3rd countries for licensing sophisticated products produced in EU but having no (or very little) therapeutic use in EU Jean-Marc Spieser, Head of Department of Biological Standardisation, OMCL Network & HealthCare (DBO), EDQM/ Council of Europe, Strasbourg

2 Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 2 Registration strategy: Eligibility for Article 58 confirmed Article 58 (regulation EC 726/2004) “The Agency may give a scientific opinion, in the context of cooperation with WHO, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community”. For this purpose, an application shall be submitted to the Agency in accordance to the provisions of article 6. The Committee for Medicinal Products for Human Use may, after consulting the WHO, draw a scientific opinion in accordance with articles 6 to 9 […]“

3 Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 3 Registration strategy: Overview CTD Dossiers WHO Pre-Qualification « GAVI » & UNICEF countries International countries National registration Art 58 CHMP opinion Submission Local Marketing Authorization Submission - scientific opinion Submission: Individual countries Marketing Authorization:

4 Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 4 Batch release and Article 58 (regulation EC 726/2004) Article 58 (regulation EC 726/2004): « Art 58 allows for testing of immunological medicinal product or a medicinal product derived from human blood or plasma by an OMCL in the European community for the purpose of batch release by a third country at the recommendation of the EMEA and in cooperation with the WHO” Likewise the European system this will be coordinated by EDQM batch release (OCABR)

5 Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 5 Batch release process under Article 58 ( OCABR : PA/PH/OMCL (04)140 3R) manufacturer Fees Sampling + production & control protocols EDQM Coordination of testing through the different OMCL Preparation of Certificate of testing (compliance) for Batch N°X OMCL T0 – sample dispatched to one or several OMCL Test results and summary of protocol evaluation 60 days Third countries Copies of Certificate of compliance for Batch N°X Perusal and formal acceptance -RELEASE-of batch N°X to be marketed Duration ? 1 2 3 5 5 4 5 6 OMCL A OMCL C OMCL B

6 Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 6 Batch release of future commercial lots Early collaboration with OMCL(s) highly recommended Lab investment Resources recruitment D0= Q4, X CTD submission CHMP positive opinion Q4, 09/ Q1, X+2 Launch QC testings by manufacturer Collaborative work manufacturer-OMCL OMCL(s) nomination D0- 6 mo = Q2, X Pre-submission meeting Start OMCL testing D0+3 mo= Q1, X+1 Blending of the 1st launch batch Batch release

7 Jean-Marc Spieser, 23/09/09 ©2009 EDQM, Council of Europe, All rights reserved 7 Thank you!

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