COS变更的分类与要求.pdf

Certification Unit CP/CB PUBLIC DOCUMENT (Level 1) English/French PA/PH/CEP (04) 2 2R July 2004 Certification of suitability of Monographs of the European Pharmacopoeia Guideline on Requirements for Revision/Renewal of Certificates (Revision of the Annex XI to Resolution AP-CSP (93) 5 as amended) Strasbourg Address: 226 Avenue de Colmar (entrance rue Schertz) B.P. 907 - F 67029 Strasbourg Cedex 1 Telephone: 33 (0) 3 88 41 30 30 - E-mail: certification@ - Fax: 33 (0) 3 88 41 27 71 Internet : PA/PH/CEP (04) 2, 2R CERTIFICATE OF SUITABILITY TO THE MONOGRAPHS OF THE EUROPEAN PHARMACOPOEIA GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES (former Appendix XI to Resolution AP-CSP (99) 4) Date of implementation: 1 September 2004 The holder of a Certificate of suitability shall inform the EDQM of any change in the information included in the certification dossier by sending an application form and all necessary documents demonstrating that the conditions laid down in the present guideline are met. Classification of changes The changes have been classified in three categories (notification/minor/major) depending on the potential impact of the change on the quality of the final substance. These three categories are based on those (IA/IB/II) of the Commission Regulation (EC) No 1084/2003 concerning the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State and the Commission Regulation (EC) No 1085/2003 concerning