Singapore legislation
Section 19A
Section 19A
Protection of confidential supporting information about innovative medicinal product
(1)
Where the licensing authority receives, or has received not more than 5 years before 16 April 1998, an innovative medicinal product application and confidential supporting information, the licensing authority, during the protected period in relation to that confidential supporting information —
must take reasonable steps to ensure that that confidential supporting information is kept confidential to the licensing authority; and
must not use that confidential supporting information for the purposes of determining whether to grant any other application.
(2)
In this section and section 19B, unless the context otherwise requires —
Definition
“application” means an application for a product licence;
Definition
“confidential information” includes —
trade secrets; and
information that has commercial value that would be, or would be likely to be, diminished by disclosure;
Definition
“confidential supporting information” means confidential information given —
in, or in relation to, an innovative medicinal product application; and
about the medicinal product that is or was (as the case may be) the subject of that application;
Definition
“innovative medicinal product application” means —
in relation to an application made after 16 April 1998, an application that refers to a substance —
that is an ingredient in the manufacture or preparation of the medicinal product to which the application relates; and
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
in relation to an application made before 16 April 1998, an application that referred to a substance —
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
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;
Definition
“licensing authority” includes any officer designated by the licensing authority under section 4(2) to determine an application for a product licence;
Definition
“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.