Certification of Substances Division
FBG/CB
PUBLIC DOCUMENT
(LEVEL 1)
PA/PH/CEP (12) 28 1R
Strasbourg, January 2015
斯坦伯格，2015年1月
Certification of suitability to the Monographs of the European Pharmacopoeia
Inspection fees and travel costs charged to companies inspected by EDQM
CEP向受EDQM检查的公司收取的检查费用和差旅费
Address: 7 Allée Kastner, CS 30026 F-67081 Strasbourg (France)
Tel: +33 (0) 3 88 41 30 30 – Fax: +33 (0) 3 88 41 27 71 - e-mail: cep@edqm.eu
Internet: http://www.edqm.eu
Date of implementation: 1st March 2015
生效日期：2015年3月1日
The costs for an EDQM inspection are charged to inspected companies and cover two areas:
EDQM检查的费用向受检公司收取，包括以下2方面：
- Inspection fees
- 检查费
- Travel and subsistence expenses for the inspectors.
- 检查员的交通和生活费
Payment should be made before the inspection takes place, after receipt of the invoice sent by EDQM.
检查费应在检查之前，收到EDQM发出的发票之后支付。
Specific financial provisions may be applicable when joint inspections are organised either outside the EU/EEA with non EU/EEA inspectorates, or inside the EU/EEA with the local competent authority.
特殊的财务项目在联合检查时可能会发生。联合检查包括EU/EEA以外与非EU/EEA组织的联合检查，或在EU/EEA内与当地药监机构组织的联合检查。
1- Inspection fees 检查费用
Inspection fees are defined in advance based on the number of inspection days. See FORM/001: “Fees and inspection costs” available on the EDQM Certification webpages.
检查费是根据检查天数预先制订的。参见EDQM认证官网公布的表001“费用和检查成本”。
2- Travel and subsistence expenses during the inspection 检查期间的差旅费和生活费
A fixed amount is charged to the company by EDQM to cover travel and subsistence expenses of the inspection team and of the interpreter, if applicable. The fixed amount has been defined for the following areas: “Asia”, “Europe” and “Other countries” based on the average cost of such inspections over the years.
EDQM向被检查公司收取固定数量的检查费用，其中涵盖检查团和所需翻译的交通及生活费用。固定数目是基于以往多年检查的平均成本，为以下区域制订的“亚洲”、“欧洲”和“其它国家”。
See FORM/001: “Fees and inspection costs” available on the EDQM Certification webpages.
参见EDQM认证官网公布的表001“费用和检查成本”。
Local transport of inspectors and interpreters hired by EDQM during the inspection are treated separately and should be paid for directly by the company.
检查期间，检查官及EDQM雇佣的翻译在当地的交通费用单独列支，应由公司直接支付。
Lunches during the inspection days are treated separately and should be provided or paid for directly by the company.
检查日期间的午餐单独列支，应由公司提供或直接支付。
以下为FORM/001
European Directorate for the Quality of Medicines & HealthCare –
Certification of Substances Division
FORM/001 – Rev 06 [16/02/2015]
FEES AND INSPECTION COSTS 费用和检查成本
Reference 索引号 | | |
| | |
| Simple certificate (chemical or TSE or herbal product) 简单证书（化学或TSE或草药产品） | |
| Double certificate (chemical + TSE)* 双证（化学+TSE） | |
| Certificate for chemical purity and sterility 化学纯度和无菌证书 | |
| Double certificate (chemical +TSE) covering also sterility 双证（化学+TSE）还包括无菌 | |
| REVISIONS OF CERTIFICATES证书修订 | |
| | |
| | |
| Grouped revision (affecting several dossiers) 组合修订（影响几个文件） | |
| Transfer of holdership 持有人转让 | |
| Major revision (may include minor changes and notifications) 主要修订（可能有小变更和通知） | |
| | |
| Evaluation of sterility data 无菌数据评估 | |
| | |
| | |
| | |
| Inspection requested by company and approved by EDQM 公司申请的检查并由EDQM批准 | |
| Inspection or re-inspection decided by EDQM (4 days) EDQM决定的检查或复查（4天） | |
| Inspection or re-inspection decided by EDQM (3 days) EDQM决定的检查或复查（3天） | |
| Inspection or re-inspection decided by EDQM (2 days) EDQM决定的检查或复查（1天） | |
| Inspection or re-inspection decided by EDQM (1 days) EDQM决定的检查或复查（1天） | |
| Travel and subsistence expenses during an inspection in Asia 亚洲检查差旅费和生活费 | |
| Travel and subsistence expenses during an inspection in Europe 欧洲检查差旅费和生活费 | |
| Travel and subsistence expenses during an inspection in elsewhere其它地区检查差旅费和生活费 | |
*In the case of TSE supported by a CEP the fees are only 3000EURO. 有CEP支持的TSE收费3000欧元。
FORM/001—Rev06[16/02/2015]
来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720151150435938/
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