TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <>. Module 1.6.1 Drug master file, plasma master file and/or EDQM certificates of suitability Details form Please note: This form is to be completed and included in Module 1.6.1 for prescription medicine applications that make reference to one or more of the following: drug master files (DMF) complete Part A – plasma master files (PMF) complete Part A – EDQM Certificates of Suitability (CEP) complete Part B – Part A - Drug master files and plasma master files Drug substance 1 Name of substance: Manufacturer’s business name: 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 Drug substance 2 Name of substance: business name: Manufacturer’s
TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <>. Module 1.6.1 Drug master file, plasma master file and/or EDQM certificates of suitability Details form Please note: This form is to be completed and included in Module 1.6.1 for prescription medicine applications that make reference to one or more of the following: drug master files (DMF) – complete Part A plasma master files (PMF) – complete Part A EDQM Certificates of Suitability (CEP) – complete Part B Part A - Drug master files and plasma master files Drug substance 1 Name of substance: Manufacturer’s business name: 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 Drug substance 2 Name of substance: Manufacturer’s business name: