Module 1 2021

25/06/2021

WHO Certificate of Pharmaceutical (CPP) Certification Scheme

• Certification confirms that certifying Authority has evaluated an application and approved it on the basis of the quality, safety and efficacy (QSE)

Therefore

CPP from any (competent) issuing Authority provides same reassurance

Irrespective of ‘source’ country marketing status

Ref: EFPIA/IFPMA position

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The dossier…..

 CTD?  CTD “plus”?  CTD “minus”?  eCTD  ACTD?

 “International” file?  Country specific file?  OTHER

What is sent from HQ vs What is submitted vs What is reviewed vs What is “Approved”

Impacts label Impacts life cycle strategies Impacts renewal Impacts COMPLIANCE

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