cos 申请表Application_form_revren.docVIP

Application Form – REQUEST FOR REVISION OR RENEWAL OF CERTIFICATE OF SUITABILITY (to be filled in for each request for revision of a Certificate of Suitability to the monographs of the European Pharmacopoeia in accordance with Resolution APCSP (99) 4) Date of submission: ……./……/…… 1. General Information: Dossier number: CEP ………………………… 1.1. Type of application (Please tick against the appropriate option:) Notification Minor change Major change Quinquennial renewal Multiple minor revisions (max 3) Multiple revisions (1 major, max 3 in total) Consolidated revision (more than 3 changes) SCOPE Please specify the scope of the change(s) in a concise way For Notifications and Minor changes, Table of Section 3 should also be filled in. 1.2 Name of the substance using the Recommended International Nonproprietary Name (rINN) (specify any subtitle requested such as sterile, micronized’)  Monograph(s) you are referring to: (Name, Number, Month/Year of publication) 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*: Street name*: Building number: Locality, district: Postcode*: City*: PO Box: State/county/province/area: Country*: Tel*: Fax*: E-mail: Fields marked * are required. 2.2 Contact name or person / company authorised for communication on behalf of the intended holder (if different from manufacturer please provide an authorisation letter -see Annex 1) Title and surname:* First name:* Job title: Department: Name of the company: Street Address*: Building number: Locality/district: Postcode*: City*: PO Box: State/county/province/area: Country*: Tel*: Fax*: E-mail*: Fields marked * are required. Tick this box if you do not wish to receive any communication from EDQM by e-mail concerning this application  2.3 Manufacturer (if different from the holder please refer