Two monographs elaborated by the P4-BIO procedure have already been adopted by the European Pharmacopoeia Commission. The so-called P4-BIO procedure takes account of the increasing number and importance of biologically-derived active substances and biosimilars on the European market. As the P4 procedure for chemical substances has been such a success, the European Pharmacopoeia Commission decided in 2009 to initiate a similar process for biological substances. Under the P4 procedure for chemical substances, a pilot project on bilateral prospective harmonisation of active substance monographs with the USP was initiated and so far has resulted in the adoption of 4 harmonised monographs. Alreadyĥ9 P4 monographs for chemical substances have been adopted by the European Pharmacopoeia Commission. Work under the P4 procedure has successfully continued during the elaboration of the 7th Edition. Observers to the European Pharmacopoeia Commission: Albania, Algeria, Argentina, Armenia, Australia, Brazil, Canada, China, Georgia, Israel, Madagascar, Malaysia, Moldova, Morocco, Republic of Belarus, Republic of Guinea, Republic of Kazakhstan, Republic of Singapore, Russian Federation, Senegal, Syria, Tunisia, United States of America and WHO (World Health Organization). Members of the European Pharmacopoeia Commission:īosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, ‘the former Yugoslav Republic of Macedonia’, Turkey, Ukraine, United Kingdom and the European Union. This list is updated where necessary and republished in each supplement. The general monographs listed below are published in the General Monographs section (unless otherwise stated). Whenever a monograph is used, it is essential to ascertain whether there is a general monograph applicable to the product in question. Where no restriction on scope of a general monograph is given in a preamble, it isapplicabletoallproducts in the class defined, irrespective of whether there is an individual monograph for the product in the Pharmacopoeia.
These general monographs give requirements that are applicable to all products in the given class or, in some cases, to any product in the given class for which there is a specific monograph in the Pharmacopoeia (see 1. The European Pharmacopoeia contains a number of general monographs covering classes of products. If you are using the 8th Edition at any time later than 1 April 2014, make sure that you have all the published supplements and consult the index of the most recent supplement to ensure that you use the latest versions of the monographs and general chapters. Note that the early availability of an edition does not modify its official publication and application dates. However, in practice, an edition may be made available before its official publication date. A cumulative list of reagents will be published in supplements 8.4 and 8.7.įor legal reasons, the official publication date of a European Pharmacopoeia edition is 6 months ahead of its application date. 2 supplements will be published in 2013 and 3 supplements in each of the years 20. They will be complemented by non-cumulative supplements that are to be kept for the duration of the 8th Edition. Volumes 1 and 2 of this publication 8.0 constitute the 8th Edition of the European Pharmacopoeia. (Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, ‘the former Yugoslav Republic of Macedonia’, Turkey, Ukraine and United Kingdom) and by the European Union.
134), signed by the governments of 37 member states
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50) (‘the Convention’) as amended by the protocol to the Convention (European Treaty Series No. The European Pharmacopoeia is prepared under the auspices of the Council of Europe in accordance with the terms of the Convention on the Elaboration of a European Pharmacopoeia (European Treaty Series No.
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