S.L. 458.31 ст. 7Decision not to include.

Any decision not to include a medicinal product in the

Government Formulary List shall be communicated to the applicant and it shall contain:

(a) a statement of reasons based upon the criteria in Schedule II, including, if appropriate, any expert opinions or recommendations on which the decision is based;

(b) information about the remedies available to the applicant under the laws in force and of the time limits allowed for applying such remedies.