Page:Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K).pdf/5

Prevention and Control of Disease (Use of Vaccines) Regulation L.N. 258 of 2020 Section 3 (4) The Secretary may authorize a vaccine only if—
 * (a) the vaccine satisfies any of the following conditions—
 * (i) a regulatory authority in a place outside Hong Kong that performs the function of approving pharmaceutical products for use in that place has approved, whether or not with any condition, limitation or restriction, the vaccine for administration to persons other than on an experimental or trial basis, including for emergency use;
 * (ii) the vaccine is listed in accordance with the emergency use listing procedure by WHO or is in the list of prequalified vaccines published by WHO;
 * (b) the Secretary considers that, for making the vaccine available urgently to deal with the threat to public health posed by the specified disease, the authorization is necessary and is in the public interest; and
 * (c) the Secretary considers that, for a specified purpose, there is no or insufficient supply of, or the vaccine is an alternative to, registered vaccines or other authorized vaccines.

(5) On determining an application for an authorization, the Secretary must—
 * (a) notify the person who makes the application of the decision in writing; and
 * (b) if the Secretary refuses the application—state the grounds for the refusal in the notification.