cep_application_form_for_revision_and_renewal_of_cepcep_application_form_for_revision_and_renewal_of_cep.docVIP

Application Form REQUEST FOR REVISION OR RENEWAL OF CERTIFICATE OF SUITABILITY (to be filled in for each request for revision or renewal of a 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 Dossier number and substance CEP …………………………/ [Substance name] ………………………… Subtitle (if applicable) .………………………… In case of grouped revision (a revision affecting several CEPs), please list the dossier numbers and substances here: CEP …………………………/ [Substance name] ………………………… Type of application (Please tick one box only) Notification (may include several changes) Minor revision (may include several changes including notifications) Major revision (may include notifications and minor changes) Renewal (notifications and minor changes may be included) Grouped revision (several dossiers affected) Transfer of holdership 2. Names and addresses 2.1 Certificate holder: (N.B. for exceptional cases where the holder will not be the manufacturer please refer to 4.2) 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 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 4.2) ° All sites involved in the man