Page:Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K).pdf/4

Prevention and Control of Disease (Use of Vaccines) Regulation L.N. 258 of 2020 Section 3 :(b) is intended to stimulate a person’s immune system to produce immunity to the specified disease.

3. Secretary may authorize vaccine for specified purpose

(1) For preventing, protecting against, delaying or otherwise controlling the incidence or transmission of, or mitigating a serious or life-threatening condition arising from, the specified disease, the Secretary may, on application, authorize a non-registered vaccine for a specified purpose.

(2) The application must be—
 * (a) made by—
 * (i) for a vaccine that satisfies the condition referred to in subsection (4)(a)(i)—a person who, in relation to the vaccine, is one described in regulation 36(1)(a), (b) or (c) of Cap. 138A; or
 * (ii) for a vaccine that satisfies the condition referred to in subsection (4)(a)(ii)—
 * (A) a person described in subparagraph (i); or
 * (B) a manufacturer of the vaccine outside Hong Kong, or a branch, subsidiary, representative, agent or distributor of the manufacturer; and
 * (b) made in the manner, and accompanied by the information, specified by the Secretary.

(3) Before the Secretary authorizes a vaccine, the Secretary must, having regard to the advice of the advisory panel, take into consideration—
 * (a) the safety of the vaccine;
 * (b) the efficacy of the vaccine; and
 * (c) the quality of the vaccine.