sábado, 30 de mayo de 2009

European Medicines Agency - Human Medicines - Medicines for children - Compliance

Medicines for children
Guidance for applicants
Electronic-only submissions: Starting with the 12 June deadline, the EMEA will accept electronic-only applications for Paediatric Investigation Plans, Waivers, Modification of Agreed Paediatric Investigation Plans, and Compliance check. This also applies to responses to the Request for Modifications. Applicants should submit their applications as a CD or DVD with a cover letter. As previously, the deadlines refer to the last acceptable day of receipt of electronic documents (via either Eudralink or CD/DVD)

According to the Paediatric Regulation, if the Paediatric Committee has decided on a paediatric investigation plan for a medicine intended for children, the pharmaceutical company will have to follow that plan exactly. Once the plan is complete, the EMEA or the medicines authorities in the Member States will check that all studies and measures required have been performed.

This compliance check is necessary before an application for marketing authorisation can be considered valid. Further information on the compliance check can be found:

-- Procedural advice for: validation of new marketing authorisation application – extension/validation application and compliance check with an agreed PIP
-- Compliance check request form
- Commission guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies
- Submission deadlines 2008-2009 for compliance check
- Submission deadlines 2010-2011 for compliance check

abrir aquí para acceder al documento central y desde allí a las secciones precitadas:
European Medicines Agency - Human Medicines - Medicines for children - Compliance

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