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

30C. Application for registration as authorized person
(1) A person who satisfies the requirements specified in paragraph (2) may apply to the Committee for registration as an authorized person.
(2) The requirements are that—
(a) the person—
(i) is a registered pharmacist; or
(ii) holds a qualification awarded on completion of a course recognized by the Committee; and
(b) the person—
(i) has at least 3 years’ relevant experience in Hong Kong or a place outside Hong Kong in manufacturing pharmaceutical products in accordance with the GMP Guide or a document similar or equivalent to that Guide issued or adopted by a competent authority of a place outside Hong Kong; or
(ii) meets any other criteria that the Committee may specify.
(3) The application must be in the specified form.
(4) The Committee may require the applicant to provide any information or document that the Committee considers reasonably necessary for determining the application.
(2 of 2015 s. 52)

30D. Registration as authorized person
(1) The Committee must decide whether to grant or refuse an application for registration made under regulation 30C.
(2) The Committee may grant an application on being satisfied that the applicant is a fit and proper person to be registered as an authorized person.
(3) A registration under this regulation is subject to any conditions the Committee thinks fit to impose.
(4) On registration, the Committee must issue to the applicant a certificate of registration in the specified form on payment of the fee prescribed in Schedule 9. (E.R. 5 of 2020)
(5) Subject to regulation 30F, a registration has effect from the date on which the certificate of registration is issued until the end of the year in which the date falls.
(6) An 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. 52; E.R. 3 of 2015)

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

30E. Renewal of registration of authorized person
(1) The Committee may, on an application, renew the registration of an authorized person.
(2) An application for renewal of registration must be in the specified form.
(3) The Committee may require the applicant to provide any information or document that the Committee considers reasonably necessary for determining the application.
(4) A registration renewed under this regulation is subject to any conditions the Committee thinks fit to impose.
(5) On renewal of registration, the Committee must issue to the applicant a renewed certificate of registration in the specified form on payment of the fee prescribed in Schedule 9. (E.R. 5 of 2020)
(6) Subject to regulation 30F, a renewed registration has effect from the date on which the renewed certificate of registration is issued until the end of the year in which the date falls.
(7) An 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. 52; E.R. 3 of 2015)

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

36D. Duplicate certificates
(1) The Committee may issue a duplicate of any certificate issued under this Part if the Committee is satisfied that the original certificate has been lost or destroyed or that for other good reason such duplicate ought to be issued.
(2) A duplicate certificate issued under this regulation shall be certified in such manner as the Committee may determine.
(3) There shall be payable in respect of any duplicate certificate issued under this regulation the fee prescribed in respect thereof in Schedule 9. (E.R. 5 of 2020)
(L.N. 369 of 1980; E.R. 3 of 2015)

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

38B. Power to specify forms
(1) An executive committee established under section 4A for a provision of these regulations may specify forms to be used for that provision.
(2) If a form is specified under this regulation, the Board must make copies of the form 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.
(2 of 2015 s. 62)

39. Keeping and transfer of records
(19 of 2020 s. 13)(1) Subject to paragraph (2), all— (19 of 2020 s. 13)
(a) poisons books;
(b) books kept under section 28(3);
(c) certificates given under section 22(1)(a) kept by authorized sellers of poisons;
(d) books or other form of records and documents required to be kept or retained by licensed wholesale dealers or licensed manufacturers under regulation 28; and (2 of 2015 s. 63)
(e) records and documents required to be kept or retained by licensed manufacturers under regulation 35, (2 of 2015 s. 63; 19 of 2020 s. 13)
shall be preserved by the authorized seller of poisons, licensed wholesale dealer or licensed manufacturer, as the case may be, in the premises in which the transaction recorded took place— (2 of 2015 s. 63)
(i) for a period of 2 years from the date of the last entry therein; or
(ii) in relation to a certificate or document, for a period of 2 years from the date of the transaction.
(2) For an advanced therapy product—
(a) all books, records and documents required to be kept or retained in respect of the product under regulations 28 and 35(1)(a), (b), (c), (ca) and (h) (specified documents

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

40. Penalties
Any person who contravenes any of the provisions of regulation 9(1) or (4), 10, 10A, 11, 12, 15, 16(1) or (2), 18, 19, 20, 21(1) or (2), 22(2), (3), (4) or (5), 23(1), (2) or (3), 24, 25, 27, 28, 29(1), 30(1), 31(1), 32, 33(1), (2), (3), (4), (4B), (4D) or (5), 34, 35, 36(1), 36A(6)(b), 38(1), 38A or 39 commits an offence and is liable on conviction to the penalties specified in section 34 of the Ordinance.
(L.N. 262 of 1995; L.N. 366 of 1995; 2 of 2015 s. 64, 19 of 2020 s. 14)

41. Certificates, forms and fees
(1) The certificate referred to in section 22(1)(a) may be given by any person known both to the intending purchaser and the intending seller and shall be in the specified form. (2 of 2015 s. 65)
(2) (Repealed 2 of 2015 s. 65)(2A) The logo referred to in section 13A(1) shall be in the form prescribed in Schedule 8. (See Schedule 8, Form 17