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

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

Jean-Marc Spieser, 23/09/09©2009 EDQM, Council of Europe, All rights reserved 2

Registration strategy: Eligibility for Article 58 confirmedRegistration 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 […]“

Jean-Marc Spieser, 23/09/09©2009 EDQM, Council of Europe, All rights reserved 3

Registration strategy: Overview

CTD

Dossiers

WHOPre-Qualification

« GAVI » &UNICEF countries

International countries

National registration

Art 58CHMP opinion

Submission

Local Marketing Authorization

Submission - scientific opinion

Submission:

Individual countries

Marketing Authorization:

Jean-Marc Spieser, 23/09/09©2009 EDQM, Council of Europe, All rights reserved 4

Batch release and Article 58 (regulation EC 726/2004)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)

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

FeesSampling + 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 AOMCL C

OMCL B

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

Batch release of future commercial lots Early collaboration with OMCL(s) highly recommended

•Lab investment•Resources recruitment

D0= Q4, XCTD submission

CHMP positive opinionQ4, 09/ Q1, X+2

Launch

QC testings by manufacturer

Collaborative work

manufacturer-OMCL

OMCL(s) nomination

D0- 6 mo = Q2, XPre-submission meeting

Start OMCL testing

D0+3 mo= Q1, X+1Blending of the 1st launch batch

Batch release

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