Import unapproved medicine into Singapore
Importing medicines into Singapore
Importing Life-Saving Unapproved Medicines for Personal Use into Singapore
The importation of unapproved or unavailable medicines for personal use in Singapore is governed by the Health Products Act (2007). This legislation outlines the specific requirements and conditions under which individuals may bring in medicines that are not registered or available locally, especially when they are life-saving.
Understanding the Health Products Act (2007)
The Health Products Act (2007) regulates the import, distribution, sale, and supply of health products in Singapore. It aims to ensure that all health products meet stringent safety, quality, and efficacy standards. Under this Act, it is generally an offence to import unregistered health products. However, exemptions are provided under certain circumstances, particularly for personal use of life-saving medicines.
Personal Importation Scheme
The Health Sciences Authority (HSA) administers a Personal Importation Scheme that allows individuals to import a small quantity of health products for personal use without the need for product registration. This scheme is designed to accommodate individuals who require medicines that are not available in Singapore.
Conditions for Importation
- The medicine is solely for personal use or for use by an immediate family member.
- The quantity imported does not exceed three months' supply.
- The medicine is not a controlled substance under the Misuse of Drugs Act or the Psychotropic Substances Act.
- The individual possesses a valid prescription or medical document from a licensed healthcare professional.
Importing Life-Saving Unapproved Medicines
For life-saving medicines that are unapproved or unavailable in Singapore, additional considerations are provided under the Health Products Act (2007). The importation of such medicines is permissible under strict conditions to ensure patient safety while accommodating urgent medical needs.
Requirements
- Medical Justification: A letter from a registered medical practitioner in Singapore detailing the medical condition and justifying the need for the unapproved medicine.
- Import Licence: An application for a Special Authorisation must be submitted to HSA for approval.
- Quantity Restriction: The quantity imported should not exceed the duration specified by the prescribing doctor, typically not more than six months' supply.
- Compliance with Regulations: The medicine must not contain prohibited substances and must comply with other relevant regulations under Singapore law.
Application Process
To import a life-saving unapproved medicine, the individual or their doctor must submit a request to the HSA. The application should include comprehensive information about the medicine, the patient's medical condition, and the justification for its use.
Steps to Apply
- Consultation: The patient should consult with a registered medical practitioner in Singapore to assess the medical necessity of the unapproved medicine.
- Documentation: Obtain a detailed medical report and prescription from the doctor, including the diagnosis, treatment history, and reasons why approved medicines are not suitable.
- Submission: Submit the application to HSA through the doctor, including all supporting documents and information about the medicine's manufacturer and supplier.
- Approval: Await the HSA's evaluation and approval. The HSA may request additional information during this process.
- Importation: Upon approval, arrange for the importation of the medicine in compliance with any conditions stipulated by the HSA.
Important Considerations
Safety and Quality Assurance
The HSA places paramount importance on the safety and quality of medicines. As such, unapproved medicines imported for personal use should come from reputable sources. Documentation verifying the quality standards of the medicine, such as Good Manufacturing Practice (GMP) certificates, may be required.
Prohibited Substances
Certain substances are prohibited in Singapore. It is crucial to ensure that the medicine does not contain any ingredients listed under the Misuse of Drugs Act or other related legislation. Importing medicines containing prohibited substances can result in severe legal consequences.
Customs Declaration
All medicines imported into Singapore must be declared to the Immigration and Checkpoints Authority (ICA) at the point of entry. Proper documentation, including the HSA approval letter and medical prescription, should be readily available for inspection.
Legal Implications
Failure to comply with the Health Products Act (2007) and associated regulations can result in penalties, including fines and imprisonment. Individuals are advised to adhere strictly to the requirements and seek professional guidance when necessary.
Seeking Professional Guidance
Due to the complexity of importing unapproved medicines, individuals are encouraged to consult healthcare professionals and legal advisors. The HSA provides resources and support for enquiries related to personal importation.
Contact Information
For further assistance, individuals can contact the HSA directly:
- Website: www.hsa.gov.sg
- Phone: +65 6866 3400
- Email: [email protected]