| Author (Corporate) | European Commission |
|---|---|
| Series Title | COM |
| Series Details | (2012) 84 final (1.3.12) |
| Publication Date | 01/03/2012 |
| Content Type | Policy-making |
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The legislation of the European Union requires a marketing authorisation to be granted by the competent EU or national authorities before any medicinal product can be placed on the market. The rules in force aim to safeguard public health by ensuring that the quality, safety and efficacy of medicines are properly evaluated before these can be made available to patients in the European Union. This legislative framework also intends to facilitate trade in medicines between Member States in accordance with the principle of free movement of goods. Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems was adopted so as to remove distortions to intra-Community trade in medicinal products. In order to take into account the evolution of the pharmaceutical market and of national policies to control public expenditure on medicines, substantive changes are necessary to all major provisions of Directive 89/105/EEC. Therefore, in the interest of clarity, that Directive should be replaced. |
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| Source Link | Link to Main Source http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0084:FIN:EN:PDF |
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| Subject Categories | Business and Industry, Health |
| Countries / Regions | Europe |
