Documentation in accordance with the Information is required for each proposed foreign manufacturer. Manufacturer Test laboratory for Type of change yet Full address of the manufacturing site (no Select as appropriate Select as appropriate not correspondence addresses, distributors or (this but approved suppliers) for If available: also give the D-U-N-S Number or IDMP Currently Applied Submitted submission) approved Quality control involves the following tests All Physical/chemical Microbiol. excluding Free text only if none of the Free text only if none of the sterility test options above applies options above applies Sterility test dated Biological Details of the manufacturer of a Coverletter 01.01.2099 solvent / diluent 01.01.2099 / Name and dosage form 3.4 Batch release of the ready-to-use medicinal product (drug product) (To read the quickinfos the cursor over the relevant field) Documentation in accordance with the Information sheet is required for each proposed foreign manufacturer. Manufacturer Release stage Type of change yet Full address of the manufacturing site (no e.g. batch release for contract Select as appropriate not correspondence addresses, distributors or manufacturer (this but approved suppliers) for Free text If available: also give the D-U-N-S Number or IDMP Currently Applied Submitted submission) approved Details of the manufacturer of a solvent / diluent Free text only if none of the options above applies dated Coverletter 01.01.2099
Documentation in accordance with the Information is required for each proposed foreign manufacturer. Currently approved Applied for (this submission) Submitted but not yet approved Manufacturer Full address of the manufacturing site (no correspondence addresses, distributors or suppliers) If available: also give the D-U-N-S Number or IDMP Test laboratory for Select as appropriate Type of change Select as appropriate Quality control involves the following tests All Physical/chemical Microbiol. excluding sterility test Sterility test Biological Free text only if none of the options above applies Free text only if none of the options above applies Coverletter dated 01.01.2099 Details of the manufacturer of a solvent / diluent 01.01.2099 / Name and dosage form 3.4 Batch release of the ready-to-use medicinal product (drug product) (To read the quickinfos the cursor over the relevant field) Documentation in accordance with the Information sheet is required for each proposed foreign manufacturer. Currently approved Applied for (this submission) Submitted but not yet approved Manufacturer Full address of the manufacturing site (no correspondence addresses, distributors or suppliers) If available: also give the D-U-N-S Number or IDMP Release stage e.g. batch release for contract manufacturer Free text Type of change Select as appropriate Details of the manufacturer of a solvent / diluent Free text only if none of the options above applies Coverletter dated 01.01.2099
zl000_00_002e_fomanufacturerinformation.docx