Health Products (Clinical Research Materials) Regulations 2016 · As enacted · Part 2 · Exceptions for Manufacture, Import and Supply of Clinical Research Materials
4. Notification of import of clinical research material
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Regulation 3(2) applies to the import of any clinical research material only if the person who imports the material (called in these Regulations an importer) gives the Authority notice of the import before importing the material.
The notice must be given in the form and manner, and within the time, specified on the Authority’s website.
A notice of the import mentioned in paragraph (1) is not required if —
before 1 November 2016 —
the clinical research material was a medicinal product under the Medicines Act 1975; and
the import of the product was permitted by the licensing authority under that Act in connection with any clinical trial regulated under the Medicines (Clinical Trials) Regulations (Rg 3); and
the clinical research material is imported in accordance with the permission.
Subregulation 1
Regulation 3(2) applies to the import of any clinical research material only if the person who imports the material (called in these Regulations an importer) gives the Authority notice of the import before importing the material.
Subregulation 2
The notice must be given in the form and manner, and within the time, specified on the Authority’s website.
Subregulation 3
A notice of the import mentioned in paragraph (1) is not required if —
before 1 November 2016 —
the clinical research material was a medicinal product under the Medicines Act 1975; and
the import of the product was permitted by the licensing authority under that Act in connection with any clinical trial regulated under the Medicines (Clinical Trials) Regulations (Rg 3); and
the clinical research material is imported in accordance with the permission.