WHO CPP药品证明书-参考格式.doc

Model certificate of a pharmaceutical product Please refer to the guidelines for full instructions on how to complete this form and information on the implementation of the Scheme. The forms are suitable for generation by computer. They should always be submitted as hard copy, with responses printed in type rather than handwritten. Additional sheets should be appended, as necessary, to accommodate remarks and explanations. Certificate of a pharmaceutical product1 This certificate conforms to the format recommended by the World Health Organization No. of certificate Exporting (certifying country): Importing (requesting country): 1. Name and dosage form of the product: 1.1. Active ingredient(s)2 and amount(s) per unit dose3: For complete composition including excipients, see attached4: 1.2. Is this product licensed to be placed on the market for use in the exporting country?5 (yes/no) 1.3 Is this product actually on the market in the exporting country? If the answer to 1.2. is yes, continue with section 2A and omit section 2B. If the answer to 1.2 is no, omit section 2A and continue with section 2B6: 2.A.1. Number of product licence7 and date of issue: 2.A.2. Product licence holder (name and address): 2.A.3. Status of product licence holder8: (Key in appropriate category as defined in note 8) 2.A.3.1. For categories b and c the name and address of the manufacturer producing the dosage form is9: 2.A.4. Is a summary basis for approval appended?10 (yes/no) 2.A.5. Is the attached, officially approved product information complete and consonent with the licence?11 (yes/no/not provided) 2.A.6. Applicant for certificate, if different from licence holder (name and address)12: 2.B.1. Applicant for certificate (name and address): 2.B.2. Status of applicant: (Key in appropriate category as defined in footnote 8) 2.B.2.1. For categories (b) and (c) the name and address of the manufacturer producing the dosage form is:9 2.B.3. Why is marketing authorization lacking? (not required/