Regulation 1
Citation
These Regulations may be cited as the Medicines (Good Manufacturing Practice Certificate) Regulations.
/akn/sg/act/sub_leg/1975/MA-RG16
Medicines (Good Manufacturing Practice Certificate) Regulations
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- Type
- Subsidiary Legislation
- Status
- In force
- Enacted
- 1975
- Sections
- 4
Quick answer
About this subsidiary legislation
Medicines (Good Manufacturing Practice Certificate) Regulations is Singapore Subsidiary Legislation, cited as Subsidiary Legislation MA-RG16 1975, currently marked in force and first recorded in 1975.
Regulation 2
Definitions
In these Regulations, unless the context otherwise requires —“active pharmaceutical ingredient” means any raw material which is used as an active ingredient in the manufacture of a medicinal product;“Good Manufacturing Practice Certificate” or “GMP Certificate” means a certificate relating to the manufacture of any medicinal product or active pharmaceutical ingredient attesting to its conformity with a Good Manufacturing Practice Standard;“Good Manufacturing Practice Standard” means the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme Guide to Good Manufacturing Practice for medicinal products or active pharmaceutical ingredients (as the case may be) or such other good manufacturing practice standard approved by the licensing authority.
Definition
“active pharmaceutical ingredient” means any raw material which is used as an active ingredient in the manufacture of a medicinal product;
Definition
“Good Manufacturing Practice Certificate” or “GMP Certificate” means a certificate relating to the manufacture of any medicinal product or active pharmaceutical ingredient attesting to its conformity with a Good Manufacturing Practice Standard;
Definition
“Good Manufacturing Practice Standard” means the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme Guide to Good Manufacturing Practice for medicinal products or active pharmaceutical ingredients (as the case may be) or such other good manufacturing practice standard approved by the licensing authority.
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.
Regulation 4
Fees
Amended byS 491/2024 wef 01/07/2024S 460/2022 wef 01/07/2022S 99/2019 wef 02/04/2019S 30/2007 wef 01/02/2007G.N. No. S 130/2002
Subregulation 1
Amended byS 491/2024 wef 01/07/2024S 460/2022 wef 01/07/2022S 99/2019 wef 02/04/2019S 30/2007 wef 01/02/2007
The fees payable for a GMP Certificate shall be as follows:
(a)
on application for a GMP Certificate—$6,570; and
(b)
for each additional GMP Certificate which does not require further assessment of conformity with any Good Manufacturing Practice Standard—$220.
Subregulation 2
Amended byG.N. No. S 130/2002
No refund shall be made in respect of any fee paid under paragraph (1).
Common questions
- What is Medicines (Good Manufacturing Practice Certificate) Regulations?
- Medicines (Good Manufacturing Practice Certificate) Regulations is Singapore Subsidiary Legislation, cited as Subsidiary Legislation MA-RG16 1975, currently marked in force and first recorded in 1975.
- Is Medicines (Good Manufacturing Practice Certificate) Regulations still in force?
- Yes — Medicines (Good Manufacturing Practice Certificate) Regulations is currently in force.
- When did Medicines (Good Manufacturing Practice Certificate) Regulations take effect?
- Medicines (Good Manufacturing Practice Certificate) Regulations was first recorded in 1975.
- How many regulations does Medicines (Good Manufacturing Practice Certificate) Regulations have?
- Medicines (Good Manufacturing Practice Certificate) Regulations contains 4 regulations.
- Where can I read the official version of Medicines (Good Manufacturing Practice Certificate) Regulations?
- The official text of Medicines (Good Manufacturing Practice Certificate) Regulations is published at sso.agc.gov.sg.