S.L. 458.31 Art. 6Application.

(1) An applicant may request that a medicinal product be included in the Government Formulary List. In such cases the applicant shall forward a separate application to the Superintendent of Public Health in accordance with the requirements laid down by the said Superintendent, as specified in the application form in Schedule I to these regulations.

(2) Any decision on the inclusion of a medicinal product on the Government Formulary List and the reference price to be paid for such product by the Government Health Services shall be taken through a single administrative procedure, which procedure shall not exceed one hundred and eightydays from date of application.

(3) The applicant shall furnish the Superintendent of Public Health with adequate information. If the information supporting the application is inadequate, the time limit set in the preceding sub-paragraph shall be suspended and the applicant shall be notified of such detailed information as may be required.