Import unapproved medicine into Rwanda

Requirements for Importing Unapproved Life-Saving Medicines into Rwanda

According to Law Nº 003/2018 Establishing Rwanda Food and Drugs Authority (2018), individuals seeking to import unapproved or unavailable life-saving medicines for personal use into Rwanda must adhere to specific regulations set by the Rwanda Food and Drugs Authority (Rwanda FDA). These regulations ensure that all imported medicines meet safety, quality, and efficacy standards to protect public health.

Authorization from Rwanda FDA

Before importing any unapproved medicine, the individual must obtain prior authorization from the Rwanda FDA. This involves submitting a detailed application that includes:

• Medical Justification: A prescription or letter from a licensed medical practitioner in Rwanda stating the necessity of the medicine for the individual's health condition.
• Medicine Details: Information about the medicine, including its generic and brand names, dosage form, strength, and intended use.
• Source Information: Details of the manufacturer or supplier, ensuring they are reputable and comply with Good Manufacturing Practices (GMP).

عملية التقديم

The application to the Rwanda FDA should be comprehensive and include the following steps:

1. Complete the Import Permit Application Form available on the Rwanda FDA website.
2. Attach all necessary documents, such as medical prescriptions, patient identification, and proof of the medicine's unavailability in Rwanda.
3. Submit the application in person or via mail to the Rwanda FDA headquarters.
4. Pay any applicable fees as stipulated by the Rwanda FDA.

Conditions and Limitations

The Rwanda FDA imposes certain conditions to regulate the importation of unapproved medicines:

• Personal Use Only: The medicine must be for the individual's personal use and not for resale or distribution.
• Quantity Limitations: The amount imported should not exceed a three-month supply unless otherwise justified.
• Compliance with Standards: The medicine should meet international quality standards, and the importer may need to provide certificates of analysis or quality.

Possible Inspections

Upon entry into Rwanda, the imported medicine may be subject to inspection by customs officials and the Rwanda FDA to ensure compliance with the import permit and safety standards.

Penalties for Non-Compliance

Failing to obtain the necessary authorization or complying with the import regulations may result in penalties, including confiscation of the medicine, fines, or legal action as prescribed by Law Nº 003/2018.

مراجع

• Rwanda Food and Drugs Authority
• Import Permit Application Form
• Ministry of Health Rwanda
• Rwanda FDA Laws and Regulations