Exceptional Medicinal Treatment Committee

L.N. 448 of 2018

HEALTH ACT

(CAP. 528)

Exceptional Medicinal Treatment Committee

(Amendment) Regulations, 2018

IN EXERCISE of the powers conferred by article 30 of the

Health Act, the Minister responsible for Health, has made the

following regulations:-

The title of these regulations is the Exceptional Medicinal Citation.

Treatment Committee (Amendment) Regulations, 2018 and these S.L. 528.08.

regulations shall be read and construed as one with the Exceptional

Medicinal Treatment Committee Regulations, hereinafter referred to

as "the principal regulations".

Regulation 5 of the principal regulations shall be Substitutes

regulation 5 of

substituted by the following

the principal

regulations.

"5. (1) The Committee shall receive applications for

exceptional medicinal treatment from the Directorate for

Pharmaceutical Affairs through an application in the form

prescribed by the Chief Medical Officer.

(2)

Applications for exceptional medicinal treatment

(a) which have not been previously approved for the

requested indication, shall be submitted to the Directorate for

Pharmaceutical Affairs by a Consultant in the medical class

and endorsed by the respective Clinical Chair;

(b) which have previously been approved for the

same requested indication, shall be submitted to the

Directorate for Pharmaceutical Affairs by a Consultant in the

medical class and endorsed by the respective Clinical Chair.

The Clinical Chair can delegate authority to endorse these

requests to the Lead Clinician;

(c) for renewals or for a change in dose of an

approved exceptional medicinal treatment, shall be

submitted to the Directorate for Pharmaceutical Affairs by

a Consultant in the medical class.

(3)

The Directorate for Pharmaceutical Affairs will from

their part file the submission and assessment to the Exceptional

Medicinal Treatment Committee for appraisal.

(4) The applications submitted to the Committee shall be

evaluated according to rules established by the Chief Medical

Officer from time to time.".

Regulation 6 of the principal regulations shall be

renumbered as regulation 6(1) and immediately thereafter there shall

be added the following new sub-regulation

"(2) The Committee may adopt and publish any necessary

procedure to process urgent and critical submissions.".

€0.18