Singapore legislation

Section 16

of Medicines Act 1975

Section 16

General power to suspend, revoke or vary licences

Amended by26/200426/200426/2004

(1)

Subject to subsection (5), the licensing authority may suspend a licence under this Part for the period that the Authority determines or may revoke, or vary the provisions of, any such licence.

(2)

Without limiting subsection (1), the licensing authority may, upon the request of the holder of a licence, revoke the licence.

Amended by26/2004

(3)

Without limiting subsection (1), the licensing authority may, upon an application by any interested person, revoke a product licence if the licensing authority is satisfied that —

(a)

a court, or the Registrar of Patents or a Deputy Registrar of Patents holding office under the Patents Act 1994, has determined that the doing of an act authorised by the licence infringes a patent under the Patents Act 1994;

(b)

the person who made a declaration mentioned in section 12A(2) in support of the application for the licence has been convicted for an offence under section 20 in respect of the declaration; or

(c)

a court has determined that the declaration —

(i)

contains a statement that is false or misleading in a material particular; or

(ii)

omits to disclose any matter that is material to the application,and the determination or conviction (as the case may be) is final.

Amended by26/2004

(4)

The suspension or revocation of a licence under this section may be total or may be limited to medicinal products of one or more descriptions or to medicinal products manufactured, assembled or stored in any particular premises or in a particular part of any premises.

(5)

Where the licensing authority proposes to exercise any power conferred by this section, the licensing authority must serve on the holder of the licence a notice giving particulars of the suspension, revocation or variation and of the reasons for the licensing authority’s decision to suspend, revoke or vary the licence.

(6)

For the purposes of subsection (3), a determination or conviction is final if —

(a)

it is upheld on appeal, review or revision;

(b)

it is not subject to further appeal;

(c)

it is not appealed against within the permitted time; or

(d)

any appeal against it is or is deemed to be withdrawn.

Amended by26/2004