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 4
1. In the event of a price freeze imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall carry out a review, at least once a year, to ascertain whether the macro-economic conditions justify that the freeze be continued unchanged Within 90 days of the start of this review, the competent authorities shall announce what increases or decreases in prices are being made, if any. 2. In exceptional cases, a person who is the holder of a marketing authorization for a medicinal product may apply for a derogation from a price freeze if this is justified by particular reasons. The application shall contain an adequate statement of these reasons. Member States shall ensure that a reasoned decision on any such application is adopted and communicated to the applicant within 90 days. 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. Should the derogation be granted, the competent authorities shall forthwith publish an announcement of the price increase allowed. Should there be 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 initial period.
Article 4
1. In the event of a price freeze imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall carry out a review, at least once a year, to ascertain whether the macro-economic conditions justify that the freeze be continued unchanged Within 90 days of the start of this review, the competent authorities shall announce what increases or decreases in prices are being made, if any. 2. In exceptional cases, a person who is the holder of a marketing authorization for a medicinal product may apply for a derogation from a price freeze if this is justified by particular reasons. The application shall contain an adequate statement of these reasons. Member States shall ensure that a reasoned decision on any such application is adopted and communicated to the applicant within 90 days. 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. Should the derogation be granted, the competent authorities shall forthwith publish an announcement of the price increase allowed. Should there be 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 initial period.
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