An RP Declaration in accordance with the Information sheet is required for each proposed foreign manufacturer. The Annex Number references the corresponding RP Declaration For details regarding manufacturers of herbal active substances see the Information sheet . PLEASE list test/release laboratories under section 2.2 Active ingredient (Designation according to , INN or pharmacopoeia): Manufacturer Manufacturing Type of change yet activities Full address of the manufacturing site (no Select as appropriate not correspondence addresses, distributors or Select as appropriate (this but approved suppliers) for If available: also give the D-U-N-S Number or IDMP Currently Applied Submitted submission) approved Own Doc. ASMF CEP Free text only if none of the Free text only if none of the master no. options above applies options above applies (YYYY-nnn): dated Annex Number: Coverletter 01.01.2099 01.01.2099 / Name and dosage form 2.2 Quality control of the active ingredient (drug substance) (To read the quickinfos place the cursor over the relevant field) No further documents required; see the Information sheet . Active ingredient (Designation according to , INN or pharmacopoeia): 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 Mikrobiol. 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 Coverletter 01.01.2099 01.01.2099 / Name and dosage form
An RP Declaration in accordance with the Information sheet is required for each proposed foreign manufacturer. The Annex Number references the corresponding RP Declaration For details regarding manufacturers of herbal active substances see the Information sheet . PLEASE list test/release laboratories under section 2.2 Active ingredient (Designation according to , INN or pharmacopoeia): 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 Manufacturing activities Select as appropriate Type of change Select as appropriate Own Doc. ASMF CEP master no. (YYYY-nnn): 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 Annex Number: 01.01.2099 / Name and dosage form 2.2 Quality control of the active ingredient (drug substance) (To read the quickinfos place the cursor over the relevant field) No further documents required; see the Information sheet . Active ingredient (Designation according to , INN or pharmacopoeia): 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 Mikrobiol. 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 01.01.2099 / Name and dosage form
zl000_00_002e_fomanufacturerinformation.docx