S.L. 458.31 Art. 14Price freeze.

(1) In the event of a price freeze imposed on all medicinal products or on certain categories of medicinal products by the Minister responsible for finance in consultation with the Minister responsible for health, the Minister responsible for finance 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 ninety days of the start of this review, the Minister responsible for finance 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.

(3) The Superintendent of Public Health shall ensure that a reasoned decision on any such application is adopted and communicated to the applicant within ninety days. If the information supporting the application is inadequate, the Superintendent of Public Health shall forthwith notify the applicant of what detailed additional information is required and take his final decision within ninety days of receipt of this additional information.

(4) Should the derogation be granted, the Superintendent of Public Health shall forthwith publish an announcement in the Gazette of the price increase allowed.

(5) Should there be an exceptional number of applications, the period may be extended once only for a further period of sixty days. The applicant shall be notified of such extension before the expiry of the initial period.