My bookmarksSign up free
Source

Health Products Act 2007 PART 6 — LICENCES

s 24–s 28 · 5 sections

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Issue and renewal of licences

s 24

Open ↗

24.—(1) An application for a licence must be made to the Authority in such form and manner as the Authority may require and must be accompanied by —(a) such particulars, information, documents and samples as the Authority may require; and (b) if required by the Authority, a statutory declaration by the applicant verifying any information contained in or relating to the application. (2) Upon receiving an application under subsection (1), the Authority may —(a) issue the licence to the applicant if it is satisfied that —(i) the applicant is a fit and proper person to be issued with a licence or otherwise satisfies such requirements as may be prescribed for the issue of the licence; and (ii) the issue of the licence to the applicant will not be contrary to the public interest; or (b) refuse to issue the licence applied for. (3) Where the Authority refuses to issue a licence to an applicant under subsection (2)(b), the Authority must, if requested to do so by the applicant, state in writing the reasons for the refusal. (4) Every licence must be issued in such form and manner as the Authority may determine, and is valid for such period as the Authority may specify in the licence unless it is sooner suspended or revoked in accordance with the provisions of this Act. (5) The Authority may attach any conditions to a licence that it thinks necessary, and may from time to time vary the conditions by written notice given to the licensee. (6) Any person who, in making an application for a licence —(a) makes any statement or furnishes any document which the person knows to be false or does not believe to be true; or (b) by the intentional suppression of any material fact, furnishes information which is misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both. (7) Subsections (1) to (6) apply, with the necessary modifications, to an application for the renewal of a licence.

Variation of licence conditions on application by licensee

s 25

Open ↗

25.—(1) A licensee may apply to the Authority for the variation of any condition attached to the licensee’s licence. (2) An application under subsection (1) must be made to the Authority in such form and manner as the Authority may require and must —(a) set out the variation required and the reasons for the variation; and (b) be accompanied by —(i) such particulars, information, documents and samples as the Authority may require; and (ii) if required by the Authority, a statutory declaration by the licensee verifying any information contained in or relating to the application. (3) Where the Authority decides to vary any condition of the licence to which the application relates, it must amend the licence or issue a new licence to the licensee as it considers appropriate. (4) Any licensee who, in making an application under subsection (1) —(a) makes any statement or furnishes any document which the licensee knows to be false or does not believe to be true; or (b) by the intentional suppression of any material fact, furnishes information which is misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

Register of licensees

s 26

Open ↗

26.—(1) The Authority must keep and maintain in such form and manner as it thinks fit a register of persons who have been issued with licences under this Act. (2) Any person may, during the office hours of the Authority and upon payment of the prescribed fee, inspect such parts of the register as the Authority may determine and obtain extracts from the register. (3) Any extract from or copy of an entry in the register is prima facie evidence of the information stated in the register if the extract or copy is certified under the hand of the Chief Executive, or an officer of the Authority duly authorised by the Chief Executive, to be a true extract or copy. (4) The Authority may, from time to time, prepare and publish in such form and manner as it thinks fit a list of all licensees.

Suspension and revocation of licence and cancellation of approval

s 27

Open ↗

27.—(1) The Authority may suspend or revoke a licence or cancel any approval granted by it under this Act if the Authority has reasonable grounds to believe that —(a) the issue of the licence or the grant of the approval has been obtained by fraud or misrepresentation; (b) the licensee or the person to whom the approval has been granted has contravened or is contravening —(i) any provision of this Act; (ii) any condition attached to the licence or approval; or (iii) any other prescribed requirement; (c) the licensee or the person to whom the approval has been granted no longer satisfies any of the prescribed requirements based on which the licence was issued or the approval was granted to the licensee or person; or (d) it is in the public interest to do so. (2) The Authority may revoke a licence or cancel any approval granted by it under this Act if the licensee or the person to whom the approval has been granted applies to the Authority for the revocation of the licence or the cancellation of the approval, as the case may be. (3) Before suspending or revoking a licence or cancelling an approval under subsection (1), the Authority must —(a) give to the person to whom the licence has been issued or the approval has been granted (hereafter called the person concerned) written notice of its intention to do so; and (b) in the notice, call upon the person concerned to show cause within the time specified in the notice as to why the licence should not be suspended or revoked or the approval should not be cancelled. (4) If the person concerned —(a) fails to show cause within the period of time given or such extended period of time as the Authority may allow; or (b) fails to show sufficient cause, as to why the licence should not be suspended or revoked or as to why the approval should not be cancelled, the Authority must give written notice to the person concerned of the date from which the suspension or revocation of the licence or the cancellation of the approval is to take effect.

Appeal

s 28

Open ↗

28.—(1) Any person who is aggrieved by —(a) the refusal of the Authority to issue or renew a licence under section 24 or to grant any approval under this Act; (b) any condition attached by the Authority to a licence under section 24; or (c) the decision of the Authority to suspend or revoke a licence or to cancel an approval under section 27, may, within the time specified in the notice informing the person of the refusal, condition, suspension, revocation or cancellation (as the case may be) appeal in writing to the Minister whose decision is final. (2) Before making a decision under subsection (1), the Minister may refer the matter to an Appeal Advisory Committee and, in making a decision, the Minister must have regard to any report made to the Minister by the Appeal Advisory Committee. (3) Even though an appeal under subsection (1) is pending —(a) any condition attached by the Authority to a licence under section 24; or (b) the decision of the Authority to suspend or revoke a licence or to cancel an approval under section 27, takes effect from the date specified by the Authority, unless the Minister otherwise directs.

Back to Health Products Act 2007 — full text

Provisions on this page are reproduced verbatim from official open data. See the attribution line.

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Read the official text ↗

Source: Singapore Statutes Online (Attorney-General's Chambers), © Government of Singapore.

The Singapore legislation on this platform is subject to copyright of the Singapore Government and is used/reproduced for the purposes of this platform with the permission of the Attorney-General's Chambers. Users of this platform may check Singapore Statutes Online for the latest version of the Singapore legislation.

What to look at next