Orphan drugs

(1) Notwithstanding regulation 4, a person shall not be required to register or obtain a product licence for an orphan drug. 136 Food and Drugs (2) Notwithstanding subregulation (1), a person shall not import into Belize or commercialise an orphan drug unless that person receives import authorisation from the competent authority, given having regard to such qualifying criteria for commercialisation as the competent authority has determined. (3) An application for importation authorisation shall be made in writing to the competent authority. (4) A person who contravenes subregulation (2) commits an offence and is liable on summary conviction to a fine not exceeding ten thousand dollars.