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
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
Change history Version Valid and binding as of: Modified without version change Description, comments (by author) Author’s initials 08 18.11.16 Section 2.1 – 3.4 Paragraph formatting, alignment of manufacturer's address corrected Name and dosage form and Medicinal Product and application clarified beg 01.09.16 Language corrected and in section 3.3 typing error corrected. cis 25.08.16 Layout adapted. cis 07 25.07.16 Completely revised, clearer specifications. A and B merged. New sections 4 and 5 inserted. gme 23.10.14 Telephone and fax numbers within the document updated, telephone and fax number in the footer updated, link(s) revised, new change history inserted in the document, document name modified in the header cas 06 01.03.14 Insert the Barcode cis