Singapore legislation

Regulation 37

of Health Products (Active Ingredients) Regulations 2023

Regulation 37

Saving and transitional provisions

Subregulation 1

Any person who, immediately before 18 December 2023, is an existing manufacturer of an active ingredient is deemed to be a holder of a manufacturer’s licence under these Regulations until the earliest of the following dates:

(a)

the date the person is issued a manufacturer’s licence under section 24(2)(a) of the Act;

(b)

the date the person’s application for a licence under these Regulations is refused or withdrawn;

(c)

17 March 2024.

Subregulation 2

Any person who, immediately before 18 December 2023, is an existing dealer of an active ingredient is deemed to be a holder of both an importer’s licence and a wholesaler’s licence under these Regulations until the earliest of the following dates:

(a)

the date the person is issued either an importer’s licence or a wholesaler’s licence under section 24(2)(a) of the Act;

(b)

the date the person’s application for any licence under these Regulations is refused or withdrawn;

(c)

17 March 2024.

Subregulation 3

In this regulation —

Definition

“existing dealer” means a person who, immediately before 18 December 2023, holds a valid licence issued under the Poisons Act 1938 for importing, storing and selling by wholesale any poison in the Poisons List in the Schedule to that Act (as set out in Form A of the Eighth Schedule to the Poisons Rules (R 1)) that is —

(a)

specified as an active ingredient in the Schedule to these Regulations; and

(b)

usable in the manufacture of any relevant health product;

Definition

“existing manufacturer” means a person who —

(a)

before 18 December 2023 engaged in any of the following activities:

(i)

the manufacture of an active ingredient;

(ii)

the primary packaging of an active ingredient;

(iii)

the secondary packaging of an active ingredient; and

(b)

immediately before 18 December 2023 holds a valid —

(i)

manufacturer’s licence issued under the Act for the manufacture of a therapeutic product or a CTGT product; or

(ii)

GMP certificate for an active pharmaceutical ingredient issued under the Medicines Act 1975;

Definition

“primary packaging”, in relation to an active ingredient, means the enclosure of the active ingredient in a container which is labelled before the active ingredient is sold or supplied;

Definition

“secondary packaging”, in relation to an active ingredient that is already enclosed in the container in which it is to be sold or supplied, means —

(a)

the labelling of the container, or enclosure of the container with other packaging material; or

(b)

the labelling of the packaging material before the product is sold or supplied in it.

Read in full context — Health Products (Active Ingredients) Regulations 2023 →