On 22/05/2013,
you requested for the version in force on 22/05/2013
incorporating all amendments published on or before 22/05/2013.
The closest version currently available is that of 01/09/2008.
PART II
LICENCES AND CERTIFICATES RELATING TO MEDICINAL PRODUCTS
4.
—(1) For the purposes of this Part, the authority responsible for the grant, renewal, variation, suspension and revocation of licences and certificates shall be —
(a)
except as provided in paragraph (b), the Chief Executive of the Authority; and
(b)
the Director-General, Agri-food and Veterinary Services appointed under section 3(1) of the Animals and Birds Act (Cap. 7) in respect of any function to be performed under this Act exclusively in relation to veterinary medicinal products and animals.
(2) Any function conferred on the licensing authority by this Act may be performed by such officers as the licensing authority may designate, subject to his general direction and control.
(3) Any person to whom a licensing authority refuses to grant, renew or vary a licence or whose licence has been suspended or revoked may appeal to the Minister whose decision shall be final.
5.
—(1) Except in accordance with a licence granted for the purposes of this section (referred to in this Act as a product licence) no person shall in circumstances to which this section applies —
(a)
sell, supply or export any medicinal product;
(b)
procure the sale, supply or exportation of any medicinal product; or
(c)
procure the manufacture or assembly of any medicinal product for sale, supply or exportation.
(2) No person shall import any medicinal product except in accordance with a product licence or an import licence.
(3) In relation to an imported medicinal product, this section shall apply to circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product, has himself imported the product or procured its importation.
(4) In relation to any medicinal product which has not been imported, this section shall apply to any circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product, is responsible for the composition of the product.
(5) For the purposes of subsection (4), a person shall be taken to be responsible for the composition of a medicinal product if —
(a)
he procures the manufacture of the product to his order by another person, where the order specifies, or incorporates by reference to some other document, particulars of the composition of the product ordered, whether those particulars amount to a complete specification or not; or
(b)
he manufactures the product otherwise than in pursuance of an order which fulfils the conditions specified in paragraph (a).
6.
—(1) This section shall have effect without prejudice to section 5.
(2) No person shall manufacture or assemble any medicinal product except in accordance with a licence granted for the purposes of this subsection (referred to in this Act as a manufacturer’s licence).
(3) No person shall sell any medicinal product by way of wholesale dealing except in accordance with a licence granted for the purposes of this subsection (referred to in this Act as a wholesale dealer’s licence).
(4) A manufacturer’s licence shall not have effect so as to authorise the manufacture or assembly of medicinal products of any description for sale or supply to any other person, or for exportation, unless —
(a)
the holder of the licence is also the holder of a product licence which is applicable to medicinal products of that description; or
(b)
the products are manufactured or assembled to the order of a person who is the holder of such a product licence,
and the products are manufactured or assembled in accordance with that product licence.
7.
—(1) The restrictions imposed by sections 5 and 6 shall not apply to anything which is done in a registered pharmacy or hospital by or under the supervision of a pharmacist —
(a)
in preparing or dispensing a medicinal product in accordance with a prescription given by a practitioner;
(b)
in assembling a medicinal product; or
(c)
in procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner, or in procuring the assembly of a medicinal product.
(2) The restrictions imposed by sections 5 and 6 shall not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where —
(a)
the product is prepared or dispensed for administration to that person or to a person under his care; or
(b)
the product, not being a vaccine, plasma or serum, is prepared or dispensed for administration to an animal which is in the possession or under the control of that person.
(3) Without prejudice to subsections (1) and (2), the restrictions imposed by sections 5 and 6 shall not apply to anything which is done in a registered pharmacy or hospital by or under the supervision of a pharmacist —
(a)
in preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed; or
(b)
in preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or (2) or in paragraph (a).
(4) The restrictions imposed by sections 5 and 6 shall not apply to the preparation, dispensing and assembly of any medicinal product by or under the supervision of a practitioner for the purpose of administration to a patient or animal under his care.
(5) The exemptions conferred by subsections (1) to (4) shall not apply to veterinary biologics except where such veterinary biologics are prepared in a veterinary centre.
(6) For the purpose of subsection (5) —
“veterinary biologics” means aggressions, serums, viruses, toxins, tuberculin, mallein, Johnin, abortin, vaccines, micro-organisms either living or killed, and products of micro-organisms intended for use in the treatment or diagnosis of diseases of animals and birds;
“veterinary centre” means a veterinary centre established under section 65 of the Animals and Birds Act [Cap. 7].
8.
—(1) The restrictions imposed by sections 5 and 6 shall not apply to the importation, sale, supply, manufacture or assembly of any herbal remedy where —
(a)
the remedy is manufactured or assembled on premises of which the person carrying on the business is the occupier and which he is able to close so as to exclude the public; and
(b)
the person carrying on the business sells or supplies the remedy for administration to a particular person after being requested by or on behalf of that person and in that person’s presence to use his own judgment as to the treatment required.
(2) Those restrictions also shall not apply to the importation, sale, supply, manufacture or assembly of any herbal remedy where the process to which the plant or plants are subjected in producing the remedy consists only of drying, crushing or comminuting, and the remedy is, or is to be, sold or supplied without any written recommendation (whether by means of a labelled container or package or a leaflet or in any other way) as to the use of the remedy.
9. The Minister may by order —
(a)
provide that, in relation to any medicinal product which was available for sale in Singapore immediately before the commencement of this Part, sections 5 and 6 shall have effect only after such period as may be specified in the order; and
(b)
provide for such other exemptions from the restrictions imposed by sections 5 and 6 as he thinks fit.
10.
—(1) The licensing authority shall maintain a register in which shall be entered all medicinal products in respect of which product licences have been granted and remain in force.
(2) The register shall be in such form and contain such particulars as the licensing authority may determine.
(3) The licensing authority may, on application by a person who is not the holder of a product licence, grant an import licence to that person to import any medicinal product for sale or supply where the licensing authority is satisfied that that product is in all respects the same as a medicinal product registered under subsection (1).
11.
—(1) Any application for the grant of a licence under this Part shall be made to the licensing authority and shall be made in such form and manner, and shall contain, or be accompanied by, such information, documents, samples and other material, as the licensing authority may require.
(2) Any such application shall indicate the descriptions of medicinal products in respect of which the licence is required, either by specifying the descriptions of medicinal products in question or by way of an appropriate general classification.
12.
—(1) Subject to the following provisions of this Part, in dealing with an application for a product licence the licensing authority shall in particular take into consideration —
(a)
the safety of medicinal products of each description to which the application relates;
(b)
the efficacy of medicinal products of each such description for the purposes for which the products are proposed to be administered;
(c)
the quality of medicinal products of each such description, according to the specification and the method or proposed method of manufacture of the products, and the provisions proposed for securing that the products as sold or supplied will be of that quality; and
(d)
whether the grant of a product licence for the medicinal products to which the application relates will be in the public interest.
(2) Where any such application indicates that the purposes for which the licence is required relate (wholly or partly) to medicinal products which have been or are to be imported, then in dealing with the application, in so far as it relates to such products, the licensing authority shall also take into consideration in particular the methods, standards and conditions of manufacture of those products and may, if he thinks fit, require the production by the applicant of any one or more of the following:
(a)
an undertaking, given by the manufacturer of any such products, to permit the premises where they are or are to be manufactured, and the operations carried on or to be carried on in the course of manufacturing them, to be inspected by or on behalf of the licensing authority;
(b)
an undertaking, given by or on behalf of the manufacturer of any such products, to comply with any prescribed conditions or any conditions attached to the licence by the licensing authority;
(c)
a declaration, given by or on behalf of the manufacturer of any such products, that, in relation to the manufacture of those products, any requirements imposed by or under the law of the country in which they are or are to be manufactured have been or will be complied with.
(3) In dealing with an application for a manufacturer’s licence the licensing authority shall in particular take into consideration —
(a)
the operations proposed to be carried out in pursuance of the licence;
(b)
the premises in which those operations are to be carried out;
(c)
the equipment which is or will be available on those premises for carrying out those operations;
(d)
the qualifications of the persons under whose supervision those operations will be carried out; and
(e)
the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products manufactured or assembled in pursuance of the licence.
(4) In dealing with an application for a wholesale dealer’s licence the licensing authority shall in particular take into consideration —
(a)
the premises in which medicinal products of the descriptions to which the application relates will be stored;
(b)
the equipment which is or will be available for storing medicinal products in those premises;
(c)
the equipment and facilities which are or will be available for distributing medicinal products from those premises; and
(d)
the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products stored in or distributed from those premises.
12A.
—(1) Subject to the provisions of this Part, in dealing with an application for a product licence, the licensing authority shall consider whether a patent under the Patents Act (Cap. 221) is in force in respect of any medicinal product to which the application relates and, if so —
(a)
whether the applicant is the proprietor of the patent; or
(b)
if he is not the proprietor of the patent, whether —
(i)
the proprietor has given his consent to or has acquiesced in the grant of the licence to the applicant; or
(ii)
the patent is invalid or will not be infringed by the doing of the act for which the licence is sought.
(2) Unless the licensing authority otherwise determines, an applicant for a product licence shall, at the time of his application and at such other time as the licensing authority may require, make and furnish to the licensing authority a declaration in the prescribed form —
(a)
stating whether a patent under the Patents Act is in force in respect of any medicinal product to which the application relates;
(b)
if he states that there is such a patent, stating whether he is the proprietor of the patent; and
(c)
if he states that he is not the proprietor of the patent, stating —
(i)
the name and other particulars of the proprietor of the patent;
(ii)
whether —
(A)
the proprietor has consented to or has acquiesced in the grant of the licence to the applicant; or
(B)
in his opinion and to the best of his belief, the patent is invalid or will not be infringed by the doing of the act for which the licence is sought; and
(iii)
such other information as may be prescribed.
(3) The licensing authority may, if the applicant has declared that in his opinion and to the best of his belief the patent is invalid or will not be infringed by the doing of the act for which the licence is sought, or if the licensing authority considers it appropriate in any particular case, require the applicant to do the following within such time as the licensing authority may determine:
(a)
serve on the proprietor of the patent a notice in the prescribed form of his application; and
(b)
furnish to the licensing authority such evidence of the service as the licensing authority may require.
(4) The licensing authority need not determine the application until the applicant has complied with subsection (2) and, where applicable, subsection (3), to the reasonable satisfaction of the licensing authority.
(5) If the licensing authority is satisfied that a notice referred to in subsection (3)(a) has been served on the proprietor of the patent, the licensing authority may grant the licence to the applicant if the proprietor has not, before the expiration of the period prescribed for the purposes of this subsection —
(a)
applied for the order or declaration by a court or the Registrar of Patents or a Deputy Registrar of Patents holding office under the Patents Act (Cap. 221), as specified in that notice; and
(b)
given written notice to the licensing authority stating that such application has been made.
(6) The licensing authority may grant the licence to the applicant if —
(a)
application for the order or declaration referred to in subsection (5)(a) has been made; and
(b)
at the enxpiration of the period prescribed for the purposes of this subsection, the order or declaration has not been obtained.
(7) For the purpose of subsection (1), the licensing authority may rely upon and shall not be concerned to inquire into the truth of any statement made in a declaration furnished under subsection (2).
(8) This section applies only to an application for a product licence made on or after the date of commencement of the Medicines (Amendment) Act 2004.
13. Subject to the provisions of this Act, on any application to the licensing authority for a licence under this Part the licensing authority —
(a)
may grant a licence containing such provisions as he considers appropriate; or
(b)
if, having regard to the provisions of this Act, he considers it necessary or expedient to do so, may refuse to grant a licence.
14.
—(1) Subject to the following provisions of this section, every licence granted under this Part, unless previously revoked, shall be for such period as may be prescribed.
(2) Any such licence, if it has not been revoked, may, on the application of the holder of the licence, be renewed by the licensing authority for the prescribed period or for such shorter period as he may determine.
(3) On an application to the licensing authority for the renewal of a licence under this Part, the licensing authority —
(a)
may renew the licence, with or without modifications, for such further period as is mentioned in subsection (2);
(b)
may grant to the applicant a new licence containing such provisions as the licensing authority considers appropriate; or
(c)
if, having regard to the provisions of this Act, he considers it necessary or expedient to do so, may refuse to renew the licence or to grant a new licence.
(4) Where an application for the renewal of a licence under this Act has been duly made, the licence shall not cease to be in force by virtue of subsections (1), (2) and (3) before the licensing authority has determined the application.
15.
—(1) The Minister may by regulations provide for the issue of provisional licences to such persons and on such terms as may be prescribed.
(2) Section 12 shall not have effect in relation to applications for provisional licences.
16.
—(1) Subject to subsection (3), the licensing authority may suspend a licence under this Part for such period as the authority may determine or may revoke, or vary the provisions of, any such licence.
(1A) Without prejudice to the generality of subsection (1), the licensing authority may, upon the request of the holder of a licence, revoke the licence.
(1B) Without prejudice to the generality of subsection (1), the licensing authority may, upon an application by any interested person, revoke a product licence if he is satisfied that —
(a)
a court, or the Registrar of Patents or a Deputy Registrar of Patents holding office under the Patents Act (Cap. 221), has determined that the doing of an act authorised by the licence infringes a patent under the Patents Act;
(b)
the person who made a declaration referred to 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.
(2) 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.
(3) Where the licensing authority proposes to exercise any power conferred by this section, he shall serve on the holder of the licence a notice giving particulars of the suspension, revocation or variation and of the reasons for his decision to suspend, revoke or vary the licence.
(4) For the purposes of subsection (1B), 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.
17. Without prejudice to any power exercisable by virtue of section 16, the licensing authority may, on the application of the holder of a licence under this Part, vary the provisions of the licence in accordance with any proposals contained in the application, if he is satisfied that the variation will not adversely affect the safety, quality or efficacy of medicinal products of any description to which the licence relates.
18. The Minister may by regulations provide for —
(a)
the conduct of clinical trials, the issue of clinical trial certificates, the exemption of clinical trials from sections 5 and 6;
(b)
the conduct of medicinal tests on animals, the issue of animal test certificates, the exemption of medicinal tests on animals from sections 5 and 6; and
(c)
the control, housing and other restrictions in the sale, supply, manufacture, importation and exportation of animal feeding stuffs in which medicinal products are incorporated,
and for any matter ancillary or incidental thereto.
19.
—(1) Where an application has been made to the licensing authority for a licence under this Part the licensing authority, before determining the application, may request the applicant to furnish to the licensing authority such information relating to the application as the licensing authority may consider necessary and, where any such request has been made the licensing authority shall not be required to determine the application until either —
(a)
the information requested has been furnished to him; or
(b)
it has been shown to his reasonable satisfaction that the applicant is unable to furnish the information.
(2) The licensing authority may serve on the holder of a licence under this Part, a notice requiring him, within such time as may be specified in the notice, to furnish to the licensing authority information of any description specified in the notice.
19A.
—(1) Where the licensing authority receives, or has received not more than 5 years before the commencement of the Medicines (Amendment) Act 1998, an innovative medicinal product application and confidential supporting information, the licensing authority, during the protected period in relation to that confidential supporting information —
(a)
shall take reasonable steps to ensure that that confidential supporting information is kept confidential to the licensing authority; and
(b)
shall not use that confidential supporting information for the purposes of determining whether to grant any other application.
(2) For the purposes of this section and section 19B, unless the context otherwise requires —
“application” means an application for a product licence;
“confidential information” includes —
(a)
trade secrets; and
(b)
information that has commercial value that would be, or would be likely to be, diminished by disclosure;
“confidential supporting information” means confidential information given —
(a)
in, or in relation to, an innovative medicinal product application; and
(b)
about the medicinal product that is or was, as the case may be, the subject of that application;
“innovative medicinal product application” means —
(a)
in relation to an application made after the commencement of the Medicines (Amendment) Act 1998, an application that refers to a substance —
(i)
that is an ingredient in the manufacture or preparation of the medicinal product to which the application relates; and
(ii)
that has not, before that application is received by the licensing authority, been referred to in any other application as an ingredient in the manufacture or preparation of the medicinal product; and
(b)
in relation to an application made before the commencement of the Medicines (Amendment) Act 1998, an application that referred to a substance —
(i)
that is or was, as the case may be, an ingredient in the manufacture or preparation of the medicinal product to which the application related; and
(ii)
that had not, before that application was received by the licensing authority, been referred to in any other application as an ingredient in the manufacture or preparation of the medicinal product;
“licensing authority” includes any officer designated by the licensing authority under section 4(2) to determine an application for a product licence;
“protected period”, in relation to confidential supporting information relating to an innovative medicinal product application received by the licensing authority, means a period of 5 years from the date the innovative medicinal product application is or was, as the case may be, received by the licensing authority.
19B.
—(1) Notwithstanding section 19A, the licensing authority may, during the protected period in relation to confidential supporting information —
(a)
disclose that confidential supporting information, or use that confidential supporting information for the purposes of determining whether to grant any application other than the application to which it relates or related, as the case may be —
(i)
with the consent of the applicant who made the application to which the confidential supporting information relates or related; or
(ii)
if that disclosure or use is, in the opinion of the licensing authority, necessary to protect the health or safety of members of the public;
(b)
disclose that confidential supporting information to —
(i)
a Government department or statutory body for the purposes of the Government department or statutory body; or
(ii)
any adviser engaged by the licensing authority to advise on any aspect of the medicinal product to which the confidential supporting information relates or is related,
if, in the opinion of the licensing authority, the Government department, statutory body or adviser, as the case may be, will take reasonable steps to ensure the confidential supporting information is kept confidential; or
(c)
disclose that confidential supporting information to any one or more of the following:
(i)
the World Health Organisation;
(ii)
the Food and Agriculture Organisation;
(iii)
any regulatory agency of a WTO Country;
(iv)
any advisory committee established under section 73;
(v)
any person or organisation, or a person or organisation within a class or classes of persons or organisations, approved by regulations made under this Act, if the disclosure is in accordance with such conditions as may be specified in the regulations.
(2) The power to grant consent under subsection (1)(a)(i) may be exercised by a person other than the applicant referred to in that subsection if —
(a)
that applicant —
(i)
has notified the licensing authority in writing that that other person may grant that consent; and
(ii)
has not notified the licensing authority in writing that that person’s authority to grant that consent has been withdrawn; or
(b)
that applicant’s rights in respect of the relevant confidential supporting information have been transferred to that person and the applicant or that other person has notified the licensing authority in writing of the transfer.
(3) For the purposes of this section, “WTO Country” means a country that is a party to the Agreement establishing the World Trade Organisation adopted at Marrakesh on 15th April 1994.
19C.
—(1) Notwithstanding any restriction on the disclosure of information imposed by any written law or rule of law, the licensing authority may from time to time publish, for the information of the public and in the manner determined by it, such particulars of applications for licences which it received as it may determine.
(2) The particulars referred to in subsection (1) excludes —
(a)
any trade secret; and
(b)
any information that has commercial value that would be, or would be likely to be, diminished by disclosure.
19D.
—(1) Where —
(a)
information has been provided by an applicant for a product licence to the licensing authority relating to the safety or efficacy of a medicinal product in support of such application; and
(b)
a product licence has been granted in respect of that medicinal product (referred to in this section as the earlier licence),
the licensing authority may not, for a period of 5 years from the date of such grant, grant a product licence to another person in respect of that or a similar medicinal product on the basis of the grant of the earlier licence unless the holder of the earlier licence has given his consent to the grant on that basis.
(2) This section applies where the earlier licence is granted —
(a)
on or after the date of commencement of the Medicines (Amendment) Act 2004; or
(b)
at any time before the date that is before the date of commencement but no earlier than 5 years before that date.
20.
—(1) Subject to section 21, any person who contravenes any of the provisions of sections 5 and 6, or who is in possession of any medicinal product for the purpose of selling, supplying or exporting it in contravention of any of those sections, shall be guilty of an offence.
(2) Where any medicinal product is imported in contravention of section 5, any person who, otherwise than for the purpose of performing or exercising a duty or power imposed or conferred by or under this Act, or any other written law, is in possession of the product knowing or having reasonable cause to suspect that it was so imported shall be guilty of an offence.
(3) Any person who, when making an application under section 11 or a declaration under section 12A(2) or giving any information he is required to give under section 19, makes a statement which he knows or has reason to believe is false in a material particular, shall be guilty of an offence.
(3A) Any person who, when required to furnish to the licensing authority any evidence or document under section 12A(3), furnishes to the licensing authority any thing which he knows or has reason to believe is forged or altered, shall be guilty of an offence.
(4) Any person who without reasonable excuse fails to comply with a requirement imposed on him by a notice under section 19(2) shall be guilty of an offence.
(5) Any person guilty of an offence under subsection (1), (2), (3) or (3A) shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 2 years or to both.
(6) Any person guilty of an offence under subsection (4) shall be liable on conviction to a fine not exceeding $2,000.
21.
—(1) Where the holder of a product licence is charged with an offence under section 20 in respect of any medicinal product which has been manufactured or assembled to his order by another person and has been so manufactured or assembled as not to comply with the provisions of that licence which are applicable to it, it shall be a defence for him to prove —
(a)
that he had communicated those provisions to that other person; and
(b)
that he did not know, and could not by the exercise of reasonable care have discovered, that those provisions had not been complied with.
(2) Where the holder of a manufacturer’s licence is charged with an offence under section 20 in respect of any medicinal products which have been manufactured or assembled by him, in circumstances where he is not the holder of a product licence which is applicable to those products, but the products were manufactured or assembled to the order of another person, it shall be a defence for him to prove that he believed, and had reasonable grounds for believing —
(a)
that the other person in question was the holder of a product licence applicable to those products; and
(b)
that the products were manufactured or assembled in accordance with that product licence.
22. On the application of any person who proposes to export medicinal products of any description, the licensing authority may issue to such person a certificate containing any such statement relating to medicinal products of that description as the licensing authority may consider appropriate having regard —
(a)
to any requirements (whether having the force of law or not) which have effect in the country to which the products are to be exported; and
(b)
to the provisions of this Act and to any licence granted or other thing done by virtue of this Act.