| 查看: 103 | 回复: 1 | |||
| 当前主题已经存档。 | |||
[交流]
乌克兰注册文件
|
|||
|
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the medicinal product: — has been registered (include date of registration); — has been rejected from registration, withdrawn from the market by competent authority or by the applicant, registration certificate is revoked or suspended by competent authority (specify reasons); —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. |
回复此楼» 猜你喜欢
祈求中本子
已经有0人回复
-
透明质酸 甲基丙烯酸酐
已经有0人回复
-
药理学论文润色/翻译怎么收费?
已经有218人回复
-
305材料专硕调剂
已经有12人回复
-
各位大佬，H口面上什么时候会评？？？
已经有30人回复
-
CSC改派-博士生交流访学
已经有19人回复
-
中山大学-第七医院-招科研助理1名（基因设计和克隆、RNA合成）
已经有0人回复
-
中山大学-第七医院-招科研助理1名（基因设计和克隆、RNA合成）
已经有1人回复
-
巴黎萨克雷大学与国家留学基金委合作博士研究生项目-脂质纳米药物/生物材料/多酚递送
已经有10人回复
-
2026年山东大学海洋学院生物与医药博士招生-李霞课题组
已经有0人回复
-
博士研究生招生
已经有0人回复
2楼2006-04-17 19:30:08