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Medicnes Act, 2003 (Act No.Iii Of 2003) Government Health Services (List Of Medicinal Products) Regulations, 2003 (L.N. 398 Of 2003 )

MEDICINES ACT, 2003 (ACT NO. III OF 2003)
Government Health Services
(List of Medicinal Products) Regulations, 2003
IN exercise of the powers conferred by the article 106 (d) of the Medicines Act, 2003, the Minister of Health has made the following regulations>-
1. (1) The title of these regulations is the Government Health
Services (List of Medicinal Products) Regulations, 2003.

Title, commencement and scope.

2004.
(2) These regulations shall come into force on the 1st May,
(3) These regulations apply where an applicant of a market authorisation wishes to apply for the coverage of a medicinal product on the list of medicines available within the Government Health Services.
2. (1) An applicant, when requesting or after being granted a market authorisation, may further request that a medicinal product be covered by the list of medicines included in the Government Health Services.
(2) In such cases the applicant shall forward a separate application to the Superintendent of Public Health in accordance with the requirements laid down by such Superintendent.
(3) In making such further request, the applicant shall furnish the Superintendent of Public Health with adequate information.
3. (1) Where the application was submitted before the issue of a market authorisation, the Superintendent of Public Health shall, within
90 days of receipt of the application or of the issue of a market authorisation, communicate the decision to the applicant. If the information supporting the application is inadequate, such time limit shall be suspended and the applicant shall be requested to provide the detailed additional information required.

Applicantís request for inclusion

of product in list of medicines.

Decision to be communicated to the applicant.

B 5290
(2) Any decision not to cover a medicinal product in the list of medicines of the Government Health Services shall include the criteria used to determine this decision and information as to the remedies available to the applicant.
(3) Any decision to exclude a medicine or a category of medicinal products from the list of medicines of the Government Health Services shall contain a statement of reasons based on objective criteria and it shall be published in an appropriate publication to be determined by the Superintendent of Public Health.

Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

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