Singapore legislation
Regulation 3
of Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
Regulation 3
Exemptions from Act
Subregulation 1
Subject to paragraphs (2), (3) and (4), sections 5 and 6 of the Act do not apply to any medicinal product that is not specified in the First Schedule, and that —
is manufactured, assembled, imported or supplied as clinical research material; or
is exported under regulation 7(5).
Subregulation 2
Paragraph (1) applies to the import by a person (called in these Regulations an importer) of the clinical research material only if the importer gives the Authority notice of the import before importing the product.
Subregulation 3
Where a person who manufactures (called a manufacturer in these Regulations) the clinical research material supplies the material, paragraph (1) applies to the supply only if the manufacturer gives the Authority notice of the supply before supplying the product.
Subregulation 4
A notice under this regulation must be given in the form and manner, and within the time, specified on the Authority’s website.
Subregulation 5
A notice of the import mentioned in paragraph (2) is not required if —
before 1 November 2016 —
the clinical research material was a medicinal product under the Act; and
the import of the product was permitted by the licensing authority under the Act in connection with any clinical trial regulated under the Medicines (Clinical Trials) Regulations (Rg 3) in force immediately before 1 November 2016; and
the clinical research material is imported in accordance with the permission.