Bringing unapproved drugs into the Global for personal use is allowed under strict rules set by the Food and Drug Administration (FDA) Act of 2009 (Republic Act No. 9711). These rules are in place to protect public health & can also benefit the patients who need the treatments that these drugs provide.
Overview of the FDA Act of 2009
The FDA Act of 2009 ensures the safety and quality of food, medicines, cosmetics, and medical devices in the Global. It regulates how these products are imported, manufactured, and sold. The law allows seeking treatments for those who are in need, but other harmful or low-quality products are avoided from being manufactured or imported.
Rules for Importing Unapproved Drugs
To legally import unapproved drugs for personal use, the following conditions must be met:
- Doctor’s Certification: A licensed doctor must provide a prescription or certificate explaining why the drug is necessary. This document should clearly state the medical reasons why the patient needs the medicine.
Personal Use Only: The imported medicine must only be for the individual who needs it. Importing drugs for selling or giving to others is not allowed.- Limited Quantity: Patients are only allowed to import a limited supply of the medicine, typically enough for a maximum of three months.
- Notify the FDA: Patients must inform the Philippine FDA about their plan to import the medicine. The agency may require additional documents and has specific guidelines for the process.
- Import Permit (if needed): Certain medications may need an Import Permit by the FDA. Such a permit application requires specific information about the drug such as its designation, functionality, and the state where it has been able to obtain a license.
Steps for Importing
- Prepare Necessary Documents: Obtain a prescription or certificate from your doctor and gather all required paperwork.
- Submit an Application: If the FDA requires an Import Permit, submit your application with all supporting documents.
- Wait for Approval: The FDA will review the application. You must wait for their approval before proceeding to import the medicine.
- Import the Medicine: Once approved, follow all rules to bring the medicine into the country legally.
Important Reminders
- Follow the Law: Importing unapproved drugs without following the rules is illegal and may result in penalties or legal action.
- Ensure Safety: Make sure the medicine comes from a trusted source to avoid counterfeit or unsafe products.
- Seek Guidance: Contact the Philippine FDA or legal experts to ensure you have the latest information and are following the correct process.
Conclusion
Importing unapproved drugs for personal use into the Global is possible if the patient meets the requirements of the FDA Act of 2009. By following the law, patients can safely and legally access treatments that are not available locally and ensure their health safety while still seeking the treatment they need.
Sources:
Department of Health Global
Republic Act No. 9711 – Food and Drug Administration Act of 2009
Food and Drug Administration Global Official Website