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 7
The following provisions shall apply if the competent authorities of a Member State are empowered to adopt decisions to exclude individual or categories of medicinal products from the coverage of its national health insurance system (negative lists). 1. Any decision to exclude a category of medicinal products from the coverage of the national health insurance system shall contain a statement of reasons based upon objective and verifiable criteria and be published in an appropriate publication. 2. Before the date referred to in Article 11 (1), Member States shall publish in an appropriate publication and communicate to the Commission the criteria which are to be taken into account by the competent authorities in deciding whether or not to exclude an individual medicinal product from the coverage of the national health insurance system. 3. Any decision to exclude an individual medicinal product from the coverage of the national health insurance system shall contain a statement of reasons based on objective and verifiable criteria. Such decisions, including, if appropriate, any expert opinions or recommendations on which the decisions are based, shall be communicated to the person responsible, who shall be informed of the remedies available to him under the laws in force and the time limits allowed for applying for such remedies. 4. Within one year of the date referred to in Article 11 (1), the competent authorities shall publish in an appropriate publication and communicate to the Commission a list of the individual medicinal products which have been excluded from the scope of its health insurance system. This information shall be updated at least every six months.
Article 7
The following provisions shall apply if the competent authorities of a Member State are empowered to adopt decisions to exclude individual or categories of medicinal products from the coverage of its national health insurance system (negative lists). 1. Any decision to exclude a category of medicinal products from the coverage of the national health insurance system shall contain a statement of reasons based upon objective and verifiable criteria and be published in an appropriate publication. 2. Before the date referred to in Article 11 (1), Member States shall publish in an appropriate publication and communicate to the Commission the criteria which are to be taken into account by the competent authorities in deciding whether or not to exclude an individual medicinal product from the coverage of the national health insurance system. 3. Any decision to exclude an individual medicinal product from the coverage of the national health insurance system shall contain a statement of reasons based on objective and verifiable criteria. Such decisions, including, if appropriate, any expert opinions or recommendations on which the decisions are based, shall be communicated to the person responsible, who shall be informed of the remedies available to him under the laws in force and the time limits allowed for applying for such remedies. 4. Within one year of the date referred to in Article 11 (1), the competent authorities shall publish in an appropriate publication and communicate to the Commission a list of the individual medicinal products which have been excluded from the scope of its health insurance system. This information shall be updated at least every six months.
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