The following annexure are to be submitted during the initial submission wherever applicable:
Annexure- 1 : Letter of Authorization
Annexure-2 : Letter of Agreement (Where the manufacturer is not intended holder of a certificate of suitability)
Annexure-3a : Letter of declaration of manufacture according to the presented dossier and to GMP rules for APIs for Human / Veterinary use.
Annexure-3b : Letter of declaration of manufacture according to the presented Dossier and to GMP rules and/or a quality assurance system.
Annexure-4 : Letter of declaration of willingness to be inspected according to the presented dossier and to the GMP rules.
Annexure-5 : Letter of declaration of manufacture regarding the use of material of human or animal origin including substances at risk of transmitting agents of animal spongiform Encephalopathy.
Annexure-6 : Letter of commitment to provide samples of required by the EDQM.
Read also: Drug Master File in Pharmaceutical Industry