WHO :- Guidance on variations to a prequalified product dossier
USFDA :-
Changes to an Approved NDA or ANDA
Changes to an Approved NDA or ANDA - Q&A
in addition, SUPAC guidelines supplement the recommended approach.
SUPAC-IR Questions and Answers about SUPAC-IR Guidance
SUPAC: Manufacturing Equipment Addendum
EMEA :- Guideline on dossier requirements for Type IA and IB notifications
Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
UK :- Variations to licences
Thailand : - VARIATION GUIDELINE
Saudi Arabia : Guidelines for Variation Requirements
USFDA :-
Changes to an Approved NDA or ANDA
Changes to an Approved NDA or ANDA - Q&A
in addition, SUPAC guidelines supplement the recommended approach.
SUPAC-IR Questions and Answers about SUPAC-IR Guidance
SUPAC: Manufacturing Equipment Addendum
EMEA :- Guideline on dossier requirements for Type IA and IB notifications
Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
UK :- Variations to licences
Thailand : - VARIATION GUIDELINE
Saudi Arabia : Guidelines for Variation Requirements
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