cep_new_application_form CEP证书申请表.docVIP

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 : eCTD NeeS PDF Paper 1. General Information: 1.1. Type of application for a new Certificate of Suitability: Please tick the appropriate option-select one only Chemical Chemical and sterile TSE Double Chemical and TSE Double and sterile 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 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* Country* Telephone* Fax* E-mail* Fields marked * are mandatory Manufacturing site s : detailed name and address of all sites° involved in the manufacture of this substance if different from the intended holder, please also refer to 4.4 ° All sites involved in the manufacture of the active substance fro