S.L. 458.31 Art. 11Price increase.

(1) Without prejudice to regulation 14, 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 Superintendent of Public Health acting on the advice of the Committee.

(2) The Superintendent of Public Health shall ensure that a decision is adopted on an application submitted, in accordance with the requirements laid down under Schedule III, by the holder of a marketing authorization to increase the price of a medicinal product and that this is communicated to the applicant within ninety days of its receipt.

(3) The applicant shall furnish the Superintendent of Public Health 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.

(4) 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 their final decision within ninety days of receipt of this additional information.

(5) In case of 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 period.

(6) In the absence of such a decision within the abovementioned period or periods, the applicant shall be entitled to apply in full the requested price increase.