cep_procedure_revised_version.pdf

COUNCIL OF EUROPE PUBLIC HEALTH COMMITTEE (Partial Agreement) ________________ RESOLUTION AP-CSP (07) 1 (adopted by the Public Health Committee (Partial Agreement) (CD-P-SP) on 21/02/2007) Certification of suitability to the monographs of the European Pharmacopoeia (revised version) The Public Health Committee (Partial Agreement) (CD-P-SP) consisting, for the purposes of the Convention on the Elaboration of a European Pharmacopoeia, of delegations appointed by the Parties to the said Convention, namely the delegations of Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, “the Former Yugoslav Republic of Macedonia”, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom and the European Union, Considering the implementation of the Procedure for the certification of suitability of monographs of the European Pharmacopoeia adopted on 1 July 1993 by the Public Health Committee (Partial Agreement) (CD-P-SP) in its resolutions AP-CSP (93) 5 and revised on: - 4 October 1996 Resolution AP-CSP (96) 5, - 8 May 1998 Resolution AP-CSP (98) 2, - 22 December 1999 Resolution AP-CSP (99) 4, Having regard to the decision taken by the European Pharmacopoeia Commission at its session of November 2006 to update and complete the resolution AP-CSP (99) 4; Has therefore decided to amend the resolution AP-CSP (99) 4 and to replace it by the text attached. 2 INTRODUCTION 1 The manufacturer of a substance will be able to provide proof that the quality of the substance is 2 suitably controlled by the relevant monographs of the European Pharmacopoeia by means of a 3 certificate of suitability granted by the Certification Secretariat of the European Directorate for the 4 Quality of