Food and Drugs (Registration, Licensing and Inspection) Regulations, 2017.

This Regulation sets forth procedures and principles of registration, licensing, inspection, confiscation or destruction, revocation and cancellation of licenses, application for importation authorization for orphan drugs, grant or refusal of license, application for amendment of product license, application for facility license, and notification of changes in businesses and ownership. The form for an application for registration of a drug is set out as Form 1 in Schedule 1 and the form for an application for facility license is set out as Form 2 in Schedule 1. This Regulation underlines that a facility licence shall not be transferred to any other person or facility. This Regulation prohibits the sale of unregistered and unlicensed drugs. Furthermore this Regulation sets forth provisions on duties and authorities of competent institutions, inspectors, duration and renewal of product and facility licence, liabilities of product licensee, and offences and penalties.