Frequently Asked Question

12. What is the procedure to be followed when an institution wants to import an unregistered medicine?

Institutions that may apply for importation of unregistered medicines under the provisions of Section 75 of the Act include hospitals, clinics and non-governmental organisations. This happens when they identify a need for a certain medicine(s) which they know to be of clinical significance but is unavailable in the country. This can be for named patients or for hospital use. The application should be written on the letterhead of the institution stating the unregistered medicine(s), the quantity to be imported, strength of the medicine, dosage form, manufacturer of the medicine and the name of the importer.