Hong Kong Regulations

PHARMACY AND POISONS REGULATIONS - REGULATION 35A

Interpretation (Part VIII)

PART VIII

REGISTRATION OF PHARMACEUTICAL PRODUCTS AND SUBSTANCES

In this Part, unless the context otherwise requires-

"additional particulars" (附加詳情), in relation to a pharmaceutical
product or substance registered before the commencement date, means those
registrable particulars of the product or substance not referred to in the
repealed regulation 36(3);

"commencement date" (生效日期) means the commencement date* of section 4
of the Pharmacy and Poisons (Amendment) (No. 2) Regulation 1995 (L.N. 366 of
1995);

"registered particulars" (註冊詳情) means-

   (a)  in relation to a pharmaceutical product or substance registered before
        the commencement date-

        (i)    such of its particulars as are registered under the repealed
               regulation 36(3); and

        (ii)   its additional particulars as contained in or ascertainable
               from the application form, the relevant literature and
               supporting documents (if any) submitted to the Committee for
               the purpose of the registration of the product or substance, or
               as contained in or ascertainable from the specimen sales packs
               or samples (or prototypes of the packs and proposed wordings of
               the labels) made available for inspection by the Committee for
               the purpose of the registration of the product or substance;

   (b)  in relation to a pharmaceutical product or substance registered on or
        after the commencement date, its registrable particulars as registered
        under regulation 36(3), or in either case, where from time to time any
        subsequent approval has been given by the Board or the Committee to
        change any of the registrable  particulars of the product or substance
        as from a certain date, then as from that date, its said particulars
        changed in accordance with such approval;

"registered product or substance" (註冊製品或物質) means any
pharmaceutical product or substance which is the subject of a valid
registration certificate issued under regulation 36(5);

"registrable particulars" (須註冊詳情), in relation to a pharmaceutical
substance, means the particulars referred to in regulation 36(3)(a), and, in
relation to a pharmaceutical product, means all of the particulars referred to
in regulation 36(3)(a) and (b); "repealed regulation 36(3)"
(已廢除的第36(3)條) means the regulation 36(3) which was in force
immediately before the commencement date. (L.N. 366 of 1995)
___________________________________________________________________________
_____ Note:

* Section 4 of the L.N. 366 of 1995 commenced operation on 28 July 1995.

"additional particulars" (附加詳情)

"commencement date" (生效日期)

"registered particulars" (註冊詳情)

"registered product or substance" (註冊製品或物質)

"registrable particulars" (須註冊詳情) "repealed regulation 36(3)"
(已廢除的第36(3)條)