Government Health Services

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) The title of these regulations is the Government Health Title,

commencement

Services (List of Medicinal Products) Regulations, 2003.

and scope.

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

2004. (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.

(1) An applicant, when requesting or after being granted a Applicantís request

for inclusion

market authorisation, may further request that a medicinal product be of product in list of

covered by the list of medicines included in the Government Health medicines.

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.

(1) Where the application was submitted before the issue of Decision to be

communicated

a market authorisation, the Superintendent of Public Health shall, within to the applicant.

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.

(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.

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