GOVERNMENT HEALTH SERVICES
(LIST OF AVAILABLE MEDICINAL PRODUCTS) ġ S.L.458.31 1
SUBSIDIARY LEGISLATION 458.31
GOVERNMENT HEALTH SERVICES (LIST OF 
AVAILABLE MEDICINAL PRODUCTS) 
REGULATIONS
1st May, 2004
LEGAL NOTICE 399 of 2003.
Title.
Services (List of Available Medicinal Products) Regulations.
Application.
market authorisation wishes to apply for the coverage of a
medicinal product on the list of medicines available within the
Government Health Services.
Request by 
applicant.
3. ( a ) An applicant may, when requesting a market
authorisation or after being granted a market
authorisation, further 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
ninety 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.
Decision to 
exclude a 
medicine.
4. 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.
