仅供技术交流 PA/PE/CEP(04)1,5R (201508 )化学合成和有微生物质量要求的文件内容 翻译:Julia 页 4 / 22 生产厂签字的声明:愿意按相关法律规定,应有关当局要求,在CEP证书签发之前或之后接受检 查。证书持有人如果不是生产工厂,该持有人也必须提交此份声明,并附上活性物质生产厂家另 一声明,保证持有人...
Page 2 of 6 EDQM PA/PH/CEP (13) 67, 2R Certification of Substances Division Below this, choose the most appropriate “Regulatory Activity” which corresponds to the type of information you are sending to the EDQM. The list of regulatory activities is as follows: • Request for new CEP ...
Strasbourg, July 2012 斯特拉斯堡，2012年7月 Certification of Suitability toMonographs of the European Pharmacopoeia Guidance on frequent changes to applications for Certificates of Suitability (CEPs)欧洲药典适用性证书常见CEP变更申请指南 Address: 7 allée Kastner CS 30026 - F 67081 Strasbourg Telephone: ...
2019年9月,EDQM得知在盐酸雷尼替丁中检出低水平NDMA,随即搁置了盐酸雷尼替丁的CEP,直到获得该物质中NDMA的形成机制的更多信息。 In October 2019, the EDQM contacted all CEP holders and requested that they extend investigations to other APIs. 2019年10月,EDQM联系了所有CEP持有人,要求将调查延伸至其它API。 In...
(Article 111 of Directive 2001/83/EC and Article 80 of Directive 2001/82/EC, Compilation of Community Procedures) • Performed before or after the CEP is granted • Aim: to verify the compliance with submitted dossier EU GMP Part II EU GMP Annexes (e.g. Annex 1 / sterile...
Strasbourg, July 2012 斯特拉斯堡，2012年7月 Certification of Suitability toMonographs of the European Pharmacopoeia Guidance on frequent changes to applications for Certificates of Suitability (CEPs)欧洲药典适用性证书常见CEP变更申请指南 Address: 7 allée Kastner CS 30026 - F 67081 Strasbourg Telephone: ...
- transfer to a new holder that is not the same legal entity as the approved one, where the transfer does not occur because of a merger or because the company is sold, and where the manufacturer does not take out the Certificate of suitability in their own name.The changes related to Ph...
Europe,Allrightsreserved5Responsibilityofthemanufacturer•IntheCEPproceduretheAPImanufacturerhastodeclare:-CompliancetoGoodManufacturingPractices(GMP)-WillingnesstobeinspectedDrFlorenceBenoit-Guyod©2012EDQM,CouncilofEurope,Allrightsreserved6Conditionsforaninspection•WhenrequestedbyamemberState,EMA(Europeanmedicines...
欧盟CEP认证 原料药、药用辅料和药包材登记 韩国DMF注册 结构式检索(企) FDA批准辅料 药物合成 药辅批文 药用辅料 有机合成方法 有机合成经典反应 化合物提纯方法 药化词典 化工标准 药智通 医疗器械 研发 器械注册审评 地方药监局产品注册信息 医疗器械临床试验 中国器械临床试验备案 ...
Eur. (CEP) procedure slightly decreased compared to 2012, the number of requests for revisions increased. The international interest in the procedure was demonstrated by a visit from expert assessors from ANVISA, the Brazilian regulatory authority, who wished to be trained in the assessment and ...