S.L. 528.8 ст. 5Duties of the Committee.

(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.