### Pharmacy and Poisons Regulations 《藥劑業及毒藥規例》

24A. Applications to be entered on list under section 25
(1) Any application under section 25(1) shall be made in writing to the Committee and shall be accompanied by the fee specified in Schedule 9. (E.R. 5 of 2020)
(2)  The Committee may grant or refuse any application under this regulation and shall notify the applicant of its decision:
Provided that if the Committee intends to refuse an application the Committee shall first notify the applicant and the applicant may, not later than 14 days after the date of such notification, submit representations in writing to the Committee in support of his application. 
(3) Where the Committee grants an application under this regulation the Committee shall notify the Board of its decision and shall state whether the applicant has paid the prescribed fee.
(4) Any applicant aggrieved by a decision made in respect of the applicant under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (2 of 2015 s. 42)
(Part 5A added L.N. 369 of 1980; E.R. 3 of 2015)

24B. Applications to register premises under section 13
An application to register premises under section 13 shall be—
(a) (Repealed 2 of 2015 s. 43)(b) submitted together with a copy of the certificate of registration of the registered pharmacist by whom or in whose presence and under whose supervision the actual sale of poisons will be conducted under section 11(1) of the Ordinance. (2 of 2015 s. 43)
(L.N. 85 of 1987)

25. Sale and supply of poisons or pharmaceutical products wholesale
A person must not, by way of wholesale dealing, sell or supply at or from any premises a pharmaceutical product, or a substance or article consisting of or containing any poison, unless the person—
(a) holds a wholesale dealer licence issued to the person by the Committee in respect of those premises;
(b) is an authorized seller of poisons; or
(c) is a licensed manufacturer selling or supplying only pharmaceutical products manufactured by the licensed manufacturer.
(2 of 2015 s. 45)

### Pharmacy and Poisons Regulations 《藥劑業及毒藥規例》

27. Sales of poisons by licensed wholesale dealers or licensed manufacturers
(2 of 2015 s. 47)A licensed wholesale dealer or licensed manufacturer must not sell or supply a poison to any person other than the following— (2 of 2015 s. 47)
(a) a licensed wholesale dealer; (2 of 2015 s. 47)
(ab) a licensed manufacturer; (2 of 2015 s. 47)
(b) an authorized seller of poisons;
(c) a registered pharmacist;
(d) a registered medical practitioner, a registered dentist or a registered veterinary surgeon; (L.N. 614 of 1997)
(e) persons who require the poison for the purpose of their trade or business;
(f) a Government department or public officer requiring the article for the purposes of the public service;
(g) a person or an establishment concerned with education or scientific research, if the article is required for the purposes of such education or research;
(h) an institution;
(i) purchasers outside Hong Kong; or
(j) a listed seller of poisons, if the poison is included in the classes of poisons in Part 2 of the Poisons List that the listed seller is licensed to sell. (2 of 2015 s. 47)
(E.R. 3 of 2015)

### Pharmacy and Poisons Regulations 《藥劑業及毒藥規例》

28A. Good Manufacturing Practice Guide
(1) The Board may issue a Good Manufacturing Practice Guide providing for the principles and guidelines of good manufacturing practice in respect of pharmaceutical products.
(2) The GMP Guide—
(a) may consist of a code, standard, rule, specification or any other documentary form of practical guidance prepared by the Board or any other body or authority; and
(b) may apply, incorporate or refer to a document that has been formulated or published by a body or authority either as in force at the time when the document is so applied, incorporated or referred to or as amended, formulated or published from time to time.
(3) If the GMP Guide is issued, the Board must by notice published in the Gazette—
(a) identify the Guide; and
(b) specify the date on which the Guide is to take effect.
(4) The Board may from time to time revise the whole or any part of the GMP Guide.
(5) If the GMP Guide is revised, the Board must by notice published in the Gazette—
(a) identify the Guide or part revised; and
(b) specify the date on which the revision is to take effect.
(6) The Board must make a copy of the GMP Guide available for inspection by the public free of charge—
(a) at the office of the Secretary during normal office hours; and
(b) in any other manner the Board thinks fit.
(7) The GMP Guide, and a notice published under paragraph (3) or (5), are not subsidiary legislation.
(2 of 2015 s. 49)

### Pharmacy and Poisons Regulations 《藥劑業及毒藥規例》

30. Manufacture to be under supervision of a registered pharmacist
(1) In all premises in which pharmaceutical products are manufactured such products shall be manufactured by or under the supervision of—
(a) a registered pharmacist; or (2 of 2015 s. 51)
(b) (Repealed 2 of 2015 s. 51)(c) a person having such other qualifications or sufficient experience as may be approved by the Board.
(2) For the purposes of paragraph (1), supervision (監督) means the exercise by any of the persons referred to in paragraph (1) of control over the process of manufacture and of the persons engaged therein. (L.N. 137 of 1978)

30A. Authorized person to certify compliance with GMP Guide etc.
(1) A licensed manufacturer must ensure that at least one authorized person is employed to be responsible for carrying out, in relation to the pharmaceutical products manufactured under the licence, the duties specified in paragraph (2).
(2) An authorized person is responsible for ensuring and certifying that—
(a) each batch of the pharmaceutical products has been manufactured and checked in accordance with the GMP Guide; and
(b) the registrable particulars of each batch of the pharmaceutical products correspond exactly with the registered particulars of the products.
(3) In this regulation—
registered particulars (註冊詳情) has the meaning given by regulation 35A;
registrable particulars (須註冊詳情) has the meaning given by regulation 35A.
(2 of 2015 s. 52)

30B. Register of authorized persons
(1) The Board must cause the Secretary to keep a register of authorized persons for the purposes of these regulations.
(2) The register may be kept in a form the Board thinks fit.
(3) The register must contain, for each person who is registered as an authorized person under this Part—
(a) the name and address of the person; and
(b) any other particulars of the person the Board thinks fit.
(4) The Board may amend the register as to the name, address or any other particulars relating to an authorized person whose name appears in the register on being satisfied that the amendment is necessary for preserving the accuracy of the register.
(5) The Secretary must make the register available for inspection by the public free of charge at the office of the Secretary during normal office hours, and in any other manner the Secretary thinks fit, so as to enable a member of the public—
(a) to ascertain whether a person is an authorized person; and
(b) to ascertain the particulars of the registration of the person.
(2 of 2015 s. 52)