Full street address of manufacturing site: client ID (if known): Manufacturer’s TGA DMF/PMF file number: letter of access included in module 1.6.3: Yes No Manufacturer’s Note: for additional drug substances, attach a separate page with the required details as above. Part B - EDQM certificates of suitability (CEP) Drug substance 1 Name of substance: business name: Manufacturer’s Full street address of manufacturing site: client ID (if known): Manufacturer’s CEP number and version: letter of access included in module 1.6.3: Yes No Manufacturer’s Drug substance 2 Name of substance: business name: Manufacturer’s Full street address of manufacturing site: client ID (if known): Manufacturer’s CEP number and version: letter of access included in module 1.6.3: Yes No Manufacturer’s Note: for additional drug substances, attach a separate page with the required details as above.
Full street address of manufacturing site: Manufacturer’s client ID (if known): TGA DMF/PMF file number: Manufacturer’s letter of access included in module 1.6.3: Yes No Note: for additional drug substances, attach a separate page with the required details as above. Part B - EDQM certificates of suitability (CEP) Drug substance 1 Name of substance: Manufacturer’s business name: Full street address of manufacturing site: Manufacturer’s client ID (if known): CEP number and version: Manufacturer’s letter of access included in module 1.6.3: Yes No Drug substance 2 Name of substance: Manufacturer’s business name: Full street address of manufacturing site: Manufacturer’s client ID (if known): CEP number and version: Manufacturer’s letter of access included in module 1.6.3: Yes No Note: for additional drug substances, attach a separate page with the required details as above.
pm-argpm-ctd-module1-forms-module-1-6-1-180615.docx