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Rules Governing Pharmaceuticals in the European Community
Author(s) -
Sauer F.,
Hankin R.
Publication year - 1987
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1987.tb03081.x
Subject(s) - transparency (behavior) , member state , directive , commission , member states , authorization , european commission , business , harmonization , european community , marketing authorization , economic community , pharmacovigilance , quality (philosophy) , position (finance) , european union , medicine , political science , law , adverse effect , pharmacology , finance , international trade , computer science , computer security , philosophy , economy , acoustics , biology , epistemology , bioinformatics , physics , economics , programming language
In the interest of public health, the European community has progressively established common scientific criteria for the evaluation of human and veterinary medicines and harmonized the national authorization procedures. One major consequence of this has been that neither the tests and trials carried out to obtain authorization nor batch controls need be repeated within the European community. Henceforth the pharmaceutical industry may benefit from two types of procedures intended to facilitate the registration of their medicinal products in the member states. One, reserved for biotechnology/high technology medicinal products, involves community coordination prior to any national decision together with special protection against copies for ten years, irrespective of the position under patent law. The other enables firms to request the recognition by the other member states of an authorization previously granted by one member state. The experience gained from these two procedures will lead to the choice of the most appropriate European registration procedure for the next decade. In the interests of the European consumer, cooperation between the 12 member states and the Commission of the European Communities has progressively increased within the Committee for Proprietary Medicinal Products (adverse effects of medicines/pharmacovigilance) and the Committee for Veterinary Medicinal Products (residues). In association with these committees, several working groups of experts attempt to approximate and codify practices in the evaluation of the quality, safety, and efficacy of medicinal products (guidelines). The Commission has recently transmitted to the Council of Ministers a proposal for a directive concerning transparency in the national systems for controlling the prices of medicinal products and their reimbursement by the social security administrations, which the European Parliament must also discuss. The Commission has also proposed the opening of discussions to enable the Community to adhere to the European Pharmacopoeia Convention. Further proposals will be submitted towards the end of 1987 in the fields of vaccines and veterinary medicines and, over the next few years, to promote the rational use of medicines, in particular, through better information for the patient and the prescriber.