Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems
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Change 1
Article 5
Where a Member State adopts a system of direct or indirect controls on the profitability of persons responsible for placing medicinal products on the market, the Member State concerned shall publish the following information in an appropriate publication and communicate it to the Commission: (a) the method or methods used in the Member State concerned to define profitability: return on sales and/or return on capital; (b) the range of target profit currently permitted to persons responsible for placing medicinal products on the market in the Member State concerned; (c) the criteria according to which target rates of profit are accorded to an individual responsible for placing medicinal products on the market, together with the criteria according to which they will be allowed to retain profits above their given targets in the Member State concerned; (d) the maximum percentage profit which any person responsible for placing medicinal products on the market is allowed to retain above his target in the Member State concerned. This information shalhbe updated once a year or when significant changes are made. Where, in addition to operating a system of direct or indirect controls on profits, a Member State operates a system of controls on the prices of certain types of medicinal products which are excluded from the scope of the profit control scheme, Articles 2, 3 and 4 shall, where relevant, apply to such price controls. However, the said Articles shall not apply where the normal operation of a system of direct or indirect controls on profits results exceptionally in a price being fixed for an individual medicinal product.
Article 5
Where a Member State adopts a system of direct or indirect controls on the profitability of persons responsible for placing medicinal products on the market, the Member State concerned shall publish the following information in an appropriate publication and communicate it to the Commission: (a) the method or methods used in the Member State concerned to define profitability: return on sales and/or return on capital; (b) the range of target profit currently permitted to persons responsible for placing medicinal products on the market in the Member State concerned; (c) the criteria according to which target rates of profit are accorded to an individual responsible for placing medicinal products on the market, together with the criteria according to which they will be allowed to retain profits above their given targets in the Member State concerned; (d) the maximum percentage profit which any person responsible for placing medicinal products on the market is allowed to retain above his target in the Member State concerned. This information shalhbe updated once a year or when significant changes are made. Where, in addition to operating a system of direct or indirect controls on profits, a Member State operates a system of controls on the prices of certain types of medicinal products which are excluded from the scope of the profit control scheme, Articles 2, 3 and 4 shall, where relevant, apply to such price controls. However, the said Articles shall not apply where the normal operation of a system of direct or indirect controls on profits results exceptionally in a price being fixed for an individual medicinal product.
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