399 tal-2003 - Regolamenti tal-2003 dwar Servizzi tas-Saħħa tal-Gvern (Lista ta’ Prodotti Mediċinali Disponibbli)

L.N. 399 of 2003

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Government Health Services

(List of Available Medicinal Products)

Regulations, 2003

IN excerise of the powers conferred by article 106 (d) of the

Medicines Act, 2003, the Minister of Health has made the following

regulations>-

(1) The title of these regulations is the Government Health Title and

commencement.

Services (List of Available Medicinal Products) Regulations, 2003.

(2) These regulations shall come into force on the 1 st May,

2004.

These regulations shall apply where an applicant of a market Application.

authorisation wishes to apply for the coverage of a medicinal product

on the list of medicines available within the Government Health Services.

(a) An applicant may, when requesting a market Request by

authorisation or after being granted a market authorisation, further applicant.

request that a medicinal product be covered by the list of medicines

included in the Government Health Services. 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 Superintendent of Public Health. The applicant shall furnish

the Superintendent of Public Health with adequate information.

(b) The Superintendent of Public Health shall within 90 days

of receipt of the application or of the issue of a market authorisation

(in the case where the application was submitted before the issue

of a market authorisation), communicate the decision to the

applicant. If the information supporting the application is

inadequate, the time limit shall be suspended and the applicant

shall be notified of what detailed additional information is required.

(c) 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.

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 be

published in an appropriate publication, as determined by the

Superintendent of Public Health.

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