Page:Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K).pdf/7

Prevention and Control of Disease (Use of Vaccines) Regulation L.N. 258 of 2020 Section 5 5. Effective period of authorization

(1) An authorization of a vaccine—
 * (a) takes effect on the date referred to in section 3(6)(b); and
 * (b) ceases to have effect when—
 * (i) the authorization is revoked under section 6; or
 * (ii) if the authorization is not so revoked—the period referred to in subsection (2) expires.

(2) For the purposes of subsection (1)(b)(ii), the period is a period of 12 months after the date on which the authorization takes effect, but the Secretary may, by notice published in the Gazette, extend the period, each time for a period of not more than 6 months.

6. Revocation of authorization

(1) The Secretary may, after having regard to the advice of the advisory panel, revoke an authorization.

(2) Without limiting subsection (1), the Secretary may revoke an authorization if—
 * (a) the Secretary considers that the risks of the authorized vaccine outweigh its benefits; or
 * (b) a condition attached to the authorization is not complied with.

(3) If the Secretary revokes an authorization, the Secretary must—
 * (a) notify the authorization applicant in writing of the revocation stating the grounds for the revocation; and
 * (b) publish a notice of the revocation in the Gazette.