cepnewappicatinfrm cep证书申请表.doc

European Directorate for the Quality of Medicines HealthCare Certification of Substances Division Page PAGE 1/ NUMPAGES 15 FORM/055 – Rev. 07 [19/11/2012] Application Form REQUEST FOR NEW CERTIFICATE OF SUITABILITY (to be filled in for each request for a new Certificate of Suitability to the monographs of the European Pharmacopoeia, in accordance with Resolution?AP-CSP (07) 1) Date of submission: ……./……/…… Format of submission (select one only): FORMCHECKBOX eCTD FORMCHECKBOX NeeS FORMCHECKBOX PDF FORMCHECKBOX Paper 1. General Information: 1.1. Type of application for a new Certificate of Suitability: (Please tick the appropriate option-select one only) FORMCHECKBOX Chemical FORMCHECKBOX Chemical and sterile FORMCHECKBOX TSE FORMCHECKBOX Double (Chemical and TSE) FORMCHECKBOX Double and sterile FORMCHECKBOX Herbal 1.2 Name of the substance using the Recommended International Nonproprietary Name (rINN). Specify any subtitle requested such as sterile, micronized: 1.3 Monograph(s) you are referring to: (Name, Number, Year of publication) 1.4 Re-test period: (not applicable for TSE Certificate of Suitability) Proposed re-test period (in months) Commercial packaging Recommended storage conditions, if applicable (To, others) Tick this box if you do not wish a re-test period FORMCHECKBOX 2. Names and addresses 2.1 Intended certificate holder: (N.B. for exceptional cases where the holder will not be the manufacturer please refer to 4.4) Name of the company* Address* Postcode* Town* Country* Telephone* Fax* E-mail* Name of a contact person within the company (if different from 2.2) Fields marked * are mandatory 2.2 Contact person authorised for communication on behalf of the intended holder: (if different from manufacturer please provide an authorisation letter - see Annex 1) Title* (Mrs, Mr, Dr) First name* Family name* Job title/Department Name of the company* Address for correspondence* Postcode* Town* C