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Предложените мерки ще бъдат включени в нова директива относно прозрачността на мерките, регулиращи цените на лекарствени продукти за употреба от човека и включването им в обхвата на националните системи за здравно осигуряване, като тя ще отмени и замени старата директива от 1989 г., която вече не отразява нарасналата сложност на процедурите за ценообразуване и възстановяване на разходите, прилагани в държавите-членки.
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European Commission has proposed to streamline and reduce the duration of national decisions on pricing and reimbursement of medicines. In the future, such decisions should be taken within 120 days for innovative medicines, as a rule, and for generic medicinal products within only 30, instead of 180 days today. The new Directive on the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems represents an important simplification measure and shall repeal and replace the longstanding Directive from 1989, which no longer reflects the increased complexity of the pricing and reimbursement procedures in the Member States. The new Directive is a key for improving orphan drugs access, as their high price is usually a prerequisite for a long negotiation process. For further information, please visit EC webportal.
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