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Historical Background and Legal Recognition

The states of Europe have a deep history of pharmacopeial activity that even now is evidenced in publications by the United Kingdom, Denmark, Sweden, Spain, and Russia that date from the late 18th century. European unification as a modern process saw the creation of a common drug standard in 1964. The European Pharmacopoeia (EP) grew out of subsequent discussions within the European Economic Committee to establish a common set of rules and guidelines for the quality of drugs among the member states. [Pg.70]

The Convention Number 50 of the European Treaty Series of the Council of Europe gives the European Pharmacopoeia legal recognition to provide harmonized specifications for medicinal substances or pharmaceutical preparations within the member states. Within the signatory countries, existing national requirements may be superceded as the EP standards are implemented (2). [Pg.70]

Alterations to the content of the EP are first presented for public review in the quarterly, PharmEuropa, which was [Pg.70]

Revision of the JP is preceded by an announcement in the Japanese Pharmacopoeial Forum (JPF). Public comment is reviewed and if appropriate, accommodated, before the change is made official via the JP or its supplement. The JPF was established in 1992 and is published quarterly in January, April, July, and October. Currently, JPXIII (1996) is official and is updated via supplements approximately every 2 years. [Pg.71]

Pharmacopeial Convention currently meets every 5 years. The first meeting of the Convention was in 1820 and was attended by a group of 11 physicians interested in providing unified information on therapeutic products available at the [Pg.71]


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Historical background

Legal Background

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