Singapore legislation

Regulation 4

of Medicines (Cessation of Application of Act to Therapeutic Products) Order 2016

Regulation 4

Saving and transitional provisions

Subregulation 1

Every application that is pending immediately before 1 November 2016 in relation to a medicinal product specified in the first column of the First Schedule is treated, on or after that date, as an application in relation to a therapeutic product specified opposite in the second column.

Subregulation 2

Every licence, certificate or permit that is valid immediately before 1 November 2016 in respect of a medicinal product and specified in the first column of the Second Schedule is treated, on or after that date and for so long as the licence, certificate or permit remains valid, as if it were a licence, certificate or other document issued in respect of a therapeutic product as specified opposite in the second column.

Subregulation 3

Every medicinal product for which a product licence is valid immediately before 1 November 2016 is deemed, on or after that date and for so long as the product licence remains valid, to be registered as a therapeutic product under the Health Products Act (Cap. 122D), and the holder of the product licence is deemed —

(a)

to be the registrant of the therapeutic product; and

(b)

to be subject to the duties of a registrant under the Health Products Act and the Therapeutic Products Regulations.

Subregulation 4

Every person holding a medicine manufacturer’s licence, import licence or wholesale dealer’s licence that is valid immediately before 1 November 2016 in respect of a medicinal product is deemed, on or after that date and for so long as the licence remains valid —

(a)

to be the holder of a health product manufacturer’s licence, an importer’s licence or a wholesaler’s licence, as the case may be; and

(b)

to be subject to the duties of a holder of the relevant licence under the Health Products Act and the Therapeutic Products Regulations.

Subregulation 5

Any declaration or notice made under section 12A(2) or (3)(a), respectively, of the Act in any application that is pending immediately before 1 November 2016 for a product licence in relation to a medicinal product is treated, on or after that date, as a declaration or notice made under regulation 23(2) or (5) of the Therapeutic Products Regulations, as the case may be.

Subregulation 6

Any permit granted under paragraph 5 of the Medicines Exemption Order that is valid immediately before 1 November 2016 is deemed, on or after that date and for so long as the permit remains valid, to be an importer’s licence under the Health Products Act.

Subregulation 7

Every registered pharmacy from which a retail pharmacy business is conducted immediately before 1 November 2016 is deemed, on or after that date and for so long as the registration remains valid, to be a licensed retail pharmacy.