GOVERNMENT HEALTH SERVICES
(LIST OF MEDICINAL PRODUCTS) ġ S.L.458.30 1
SUBSIDIARY LEGISLATION 458.30
GOVERNMENT HEALTH SERVICES (LIST OF 
MEDICINAL PRODUCTS) REGULATIONS
1st May, 2004
LEGAL NOTICE 398 of 2003.
Title and scope.
Services (List of Medicinal Products) Regulations.
(2) 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.
Applicant’s request 
for inclusion of 
product in list of 
medicines.
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.
Decision to be 
communicated to 
the applicant.
3. (1) Where the application was submitted before the issue
of a market authorisation, the Superintendent of Public Health
shall, within ninety 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.
