31 OCTOBER 2008

GUIDELINE TO APPLY FOR APPROVAL TO IMPORT AN UNREGISTERED MEDICINAL PRODUCT FOR USE ON NAMED-PATIENT BASIS

EXEMPTION DRUG APPROVAL GUIDELINE

31 OCTOBER 2008

The application form is for requesting the approval to import ONE consignment of an unregistered medicinal product for use on a namedpatient basis, and should be submitted by the importer of the product. Each application form is to be used for ONE product only. Only unregistered medicinal products intended for the treatment of human ailments are applicable under this application. Products meant for veterinary use, laboratory research and/or clinical trial are to be excluded. For products containing ingredient(s) controlled under the Poisons Act or the Misuse of Drugs Act, the importer must comply with the applicable licensing requirements, eg. Poisons Licence, Licence to Import Controlled Drugs, etc. For first-time application, the package insert and product labels are to be submitted as supporting documents for the particular product. Approval may be granted for up to a maximum of 3 months supply of the unregistered medicinal product, at the discretion of the licensing authority. The consignment of the unregistered medicinal product must be imported within 6 months from the approval date, unless otherwise stated. Sections A and B must be completed and duly signed by the importer. The information must be typed or neatly written in the application form. The application will be deemed incomplete if any of the sections are not filled in, and will be returned to applicant for amendments. Section D of the application form must be filled by the requesting doctor only when applying for import of an unregistered medicinal product for use on a named patient basis. By completing Section D, the doctor would have acknowledged he takes full responsibility for the use of this product on the named-patient. When an application is for more than one patient under the same doctor for the same product, a single application form may be used. The required information pertaining to the patients, as specified in Section D, must be collated and attached to the application form. The completed application form is to be submitted (via fax) by the importer to: Pharmaceuticals & Biologics Branch (PBB) Therapeutic Products Division Health Products Regulation Group Health Sciences Authority Fax: 6478-9032. For enquiry or more information, please contact the Pharmaceuticals & Biologics Branch (PBB) at tel: 6866-3435 or fax: 6478-9032 or email: HSA_MedProd_Enquiry@hsa.gov.sg
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HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP

Contact Officer: Dr Lou Huei-Xin Deputy Director Clinical Regulatory Unit Pharmaceuticals & Biologics Branch Therapeutic Products Division Health Products Regulation Group Health Sciences Authority 11 Biopolis Way, #11-03 Helios Singapore 138667 www.hsa.gov.sg T: 6866 3435 F: 6478 9032