Section 16Sec./Art. 16

Permit for Restricted Use of an Orphan Drug/Orphan Product. Any person may import any orphan drug/orphan product for compassionate use: Provided, That they secure a compassionate special permit from the Food and Drug Administration (FDA) in accordance with DOH Administrative Order No. 4, series of 1992, and any future guidelines that may be issued on the same.

Within thirty (30) days from receipt of the requirements, the FDA shall issue a permit for restricted use of an orphan drug/orphan product which shall be effective for a period of three (3) years, renewable for a period of three (3) years thereafter: Provided, That the FDA shall expedite the said permit in cases of emergency.

ARTICLE VI

IMPLEMENTATION