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Singapore legislation

Regulation 3

of Medicines (Good Manufacturing Practice Certificate) Regulations

Regulation 3

Application for GMP Certificate

Amended byS 37/2013 wef 01/02/2013

Subregulation 1

For the purposes of section 22 of the Act, an application for a GMP Certificate shall be made to the licensing authority in such form and manner as the licensing authority may require.

Subregulation 2

Upon receipt of an application under paragraph (1), the licensing authority may, upon assessment of satisfactory conformity with a Good Manufacturing Practice Standard, issue a GMP Certificate to the manufacturer of any medicinal product or active pharmaceutical ingredient, subject to such terms and conditions as the licensing authority thinks fit.

Subregulation 3

Amended byS 37/2013 wef 01/02/2013

Every GMP Certificate issued under paragraph (2) shall be valid —

(a)

if issued before 1st February 2013, for a period not exceeding 2 years from the date of the certificate; and

(b)

if issued on or after that date, for a period not exceeding 3 years from the date the assessment referred to in that paragraph is completed.