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乌克兰注册文件
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Ukraine - Registration Initial Documents Part I. General documentation. I A. Administrative data: Name of the medicinal product, dosage form and strength; Quantitative and qualitative composition of active substances and excipients; pharmaco-therapeutic group (ATC-code or proposals for it); Proposals for dispensing/classification (on prescription, without prescription); Number of units in package; Container, closure; Storage conditions; Shelf life (if applicable — shelf life after first opening of container or after reconstitution); Information about applicant: — name and address; — name of authorized representative; Information about manufacturer (-s) of the finished medicinal product: — name and address, including location of facility; Information about manufacturer (-s) of active substance (-s): — name and address; List of countries, in which the medicinal product: — has been registered (include date of registration); — has been rejected from registration, withdrawn from the market by competent authority or by the applicant, registration certificate is revoked or suspended by competent authority (specify reasons); — Application for marketing authorization is pending by competent authority; Copy of manufacturing license for all sites of manufacturer including co¬pies of GMP certificates verified by competent authorities of host countries of the manufacturer; Summary of product characteristics (patient information leaflet), adopted in other countries; List of the documents submitted (table of contents) with the indication of pa¬ges, (if some parts of documentation had not been included in materials, it is necessary to give in appropriate place the reason under appropriate heading).; Samples of the medicinal product: — sample in final, immediate and outer packaging*; - certificate of quality for three production batches of the medicinal product or one certificate for one produced batch following by the commitment to present certificates for other two parties as soon as they are available (all certificates are to be submitted for each declared manufacturing site). I B. Summary of product characteristics; proposals for packaging, labe¬ling, instructions for medical use and/or package insert. I C. Expert reports on chemical, pharmaceutical, pharmacological, toxicological and clinical data (summary of product's) Part II. Chemical, pharmaceutical and biological documentation. II. Table of contents. II A. Composition of the medicinal product. II B. Flow-chart of the manufacturing process or draft of technological requirements. II C. Control tests of starting materials. II D. Control tests of intermediate products. II E. Control tests of the finished medicinal product. II F. Data about stability. II G. Bioavailability/bioequivalence. II H. Data related to the environmental risk assessment for products containing genetically modified organisms. II Q. Other information. Part III. Pharmacological and toxicological documentation. III. Table of contents. Ill A. Toxicity after a single dose and after repeated administration. Ill B. Effect on reproductive function. Ill C. Embryo-fetal and perinatal toxicity. Ill D. Mutagenic potential data. Ill E. Carcinogenicity data. Ill F. Pharmacodynamics: specific pharmacological effect data; general pharmacology data; drug interactions data. Ill G. Pharmacokinetics. Ill H. Local tolerance data. Ill Q. Other information (alergenicity data etc). Part IV. Clinical documentation. IV. Table of contents. IV A. Clinical pharmacology (pharmacodynamics, pharmacokinetics). IV B. Results of clinical trials, scientific publications. IV Q. Other information. 1 samples* for each medicinal form, dosage and number of pack to State Parmacological Center. 1 sample* of the substance (standard) The quantity of the samples and active ingredients or other materials, which should be submit to State Laboratory of quality control will depend on the methods of analysis of finished product. |
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2楼2006-04-17 19:30:08