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 3
Without prejudice to Article 4, the following provisions shall apply if an increase in the price of a medicinal product is permitted only after prior approval has been obtained from the competent authorities: 1. Member States shall ensure that a decision is adopted on an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorization to increase the price of a medicinal product and communicated to the applicant within 90 days of its receipt. The applicant shall furnish the competent authorities with adequate information including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information. In case of an exceptional number of applications, the period may be extended once only for a further 60 days. The applicant shall be notified of such extension before the expiry of the period. In the absence of such a decision within the abovementioned period or periods, the applicant shall be entitled to apply in full the price increase requested. 2. Should the competent authorities decide not to permit the whole or part of the price increase requested, the decision shall contain a statement of reasons based on objective and verifiable criteria and the applicant shall be informed of the remedies available to him under the laws in force and the time limits allowed for applying for such remedies. 3. At least once a year, the competent authorities shall publish in an appropriate publication and communicate to the Commission, a list of the medicinal products for which price increases have been granted during the relevant period, together with the new price which may be charged for such products.
Article 3
Without prejudice to Article 4, the following provisions shall apply if an increase in the price of a medicinal product is permitted only after prior approval has been obtained from the competent authorities: 1. Member States shall ensure that a decision is adopted on an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorization to increase the price of a medicinal product and communicated to the applicant within 90 days of its receipt. The applicant shall furnish the competent authorities with adequate information including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information. In case of an exceptional number of applications, the period may be extended once only for a further 60 days. The applicant shall be notified of such extension before the expiry of the period. In the absence of such a decision within the abovementioned period or periods, the applicant shall be entitled to apply in full the price increase requested. 2. Should the competent authorities decide not to permit the whole or part of the price increase requested, the decision shall contain a statement of reasons based on objective and verifiable criteria and the applicant shall be informed of the remedies available to him under the laws in force and the time limits allowed for applying for such remedies. 3. At least once a year, the competent authorities shall publish in an appropriate publication and communicate to the Commission, a list of the medicinal products for which price increases have been granted during the relevant period, together with the new price which may be charged for such products.
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