Name of the company responsible for the DMF/PMF/CEP: Is Module(s) 1.6.1, 1.6.2 and/or 1.6.3 attached? Yes No Note: refer to and guidance on Module 1 of the Common Technical Document for further information about DMFs, PMFs and CEPs. 2.3.2 Good Manufacturing Practice (GMP) If the request involves adding, ceasing or changing sites of manufacture, or steps of manufacture at existing sites from the existing medicine, please provide details of those manufacturing sites or steps that are proposed to change: Information is only required for new sites or those sites that are proposed to change. The relevant steps of manufacture are those that are acceptable for entry in the ARTG database. Note: Requirements for GMP clearances, certifications and manufacturing licence applications are available from the of the TGA website. Details of changes to overseas manufacturers from existing medicine Client ID TGA GMP Manufacturer Steps of Expiry Addition or Clearance number Name and full site manufacture Date cessation? (e.g. 12345) address (e.g. MI-2012-CL-12345-1) *Note: GMP clearances must be valid for at least 6 months. Please attach additional pages to the form if there are more than three manufacturers. Details of changes to Australian manufacturers from existing medicine Client ID Licence number Manufacturer Name and full Steps of Addition or site address manufacture cessation? (e.g. 12345) (e.g. MI-2012-CL-12345-1) Please attach additional pages to the form if there are more than three manufacturers.
Name of the company responsible for the DMF/PMF/CEP: Is Module(s) 1.6.1, 1.6.2 and/or 1.6.3 attached? Yes No Note: refer to and guidance on Module 1 of the Common Technical Document for further information about DMFs, PMFs and CEPs. 2.3.2 Good Manufacturing Practice (GMP) If the request involves adding, ceasing or changing sites of manufacture, or steps of manufacture at existing sites from the existing medicine, please provide details of those manufacturing sites or steps that are proposed to change: Information is only required for new sites or those sites that are proposed to change. The relevant steps of manufacture are those that are acceptable for entry in the ARTG database. Note: Requirements for GMP clearances, certifications and manufacturing licence applications are available from the of the TGA website. Details of changes to overseas manufacturers from existing medicine Client ID (e.g. 12345) TGA GMP Clearance number (e.g. MI-2012-CL-12345-1) Manufacturer Name and full site address Steps of manufacture Expiry Date Addition or cessation? *Note: GMP clearances must be valid for at least 6 months. Please attach additional pages to the form if there are more than three manufacturers. Details of changes to Australian manufacturers from existing medicine Client ID (e.g. 12345) Licence number (e.g. MI-2012-CL-12345-1) Manufacturer Name and full site address Steps of manufacture Addition or cessation? Please attach additional pages to the form if there are more than three manufacturers.
pm-forms-section9d-s23-sar-140805.docx