WORLD TRADE ORGANIZATION
ORGANISATION MONDIALE DU COMMERCE
ORGANIZACIÓN MUNDIAL DEL COMERCIOIP/N/1/SGP/U/2
14 March 2000
(00-1010)
Council for Trade-Related Aspects of
Intellectual Property RightsOriginal:  English/
anglais/
inglés
MAIN DEDICATED INTELLECTUAL PROPERTY
LAWS AND REGULATIONS NOTIFIED UNDER
ARTICLE 63.2 OF THE AGREEMENT
SINGAPORE
The present document reproduces the text1 of the Medicines Act Revised Edition 1985, as
notified by Singapore under Article 63.2 of the Agreement (see document IP/N/1/SGP/3).
Conseil des aspects des droits de propriétéintellectuelle qui touchent au commerce
PRINCIPALES LOIS ET REGLEMENTATIONS CONSACREES A LA
PROPRIETE INTELLECTUELLE NOTIFIEES AU TITRE
DE L'ARTICLE 63:2 DE L'ACCORD
SINGAPOUR
Le présent document contient le texte
1 de l'Édition révisée de 1985 de la Loi sur les
médicaments, notifiée par Singapour au titre de l'article 63:2 de l'Accord (voir le document
IP/N/1/SGP/3).
Consejo de los Aspectos de los Derechos de PropiedadIntelectual relacionados con el Comercio
PRINCIPALES LEYES Y REGLAMENTOS DEDICADOS A LA PROPIEDAD
INTELECTUAL NOTIFICADOS EN VIRTUD DEL PÁRRAFO 2
DEL ARTÍCULO 63 DEL ACUERDO
SINGAPUR
En el presente documento se reproduce el texto
1 de la Ley de Medicamentos, edición revisada
de 1985, notificada por Singapur de conformidad con el párrafo 2 del artículo 63 del Acuerdo (véase
el documento IP/N/1/SGP/3).
                                                     
1English only./Anglais seulement./En inglés solamente.IP/N/1/SGP/U/2
Page 2
MEDICINES ACT
(CHAPTER 176)
REVISED EDITION 1985
Act 52 of 1975
S156/93
7 of 1998
Protection of confidential supporting information about innovative medicinal
product
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 in-
novative medicinal product application and confidential supporting information, the
licensing authority, during the protected period in relation to that confidential sup-porting information —
(a) shall take reasonable steps to ensure that that confidential supporting infor-
mation 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 Medi-
cines (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; andIP/N/1/SGP/U/2
Page 3
(ii) that has not, before that application is received by the licensing au-
thority, 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 Med-
icines (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 re-
lated; and
(ii) that had not, before that application was received by the licensing
authority, been referred to in any other application as an ingredientin 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.
Circumstances where protection under section 19A does not apply
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; orIP/N/1/SGP/U/2
Page 4
(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 in-
formation 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.
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