Interpretation

In these Regulations, unless the context otherwise requires“the Act” means the Food and Drugs Act; “authorised officer” means an officer that has been authorized in writing by the Minister to exercise any of the powers conferred in these Regulations; “commercialise” means to make available on the market, and “commercialisation” shall be construed accordingly; “competent authority” means the Director of Health Services or his nominee in the Ministry; “drug” means any substance or mixture of substances, whether for internal or external use, manufactured, sold or represented for use inFood and Drugs 133 (a) the diagnosis, treatment, mitigation, or prevention of a disease, disorder, abnormal physical state, of the symptoms thereof, in man; or (b) restoring, correcting of modifying organic functions in man; “facility licence” means a facility licence granted by the competent authority, under regulation 10; “finished drug” means the final dosage form of a drug that has gone through all manufacturing stages, including packaging into the container and final packaging; “import authorisation” means a written authorisation issued by the competent authority authorising the commercialisation of an “inspector” means an inspector appointed under this regulation; “manufacturing plant” means a facility that carries out operations involved in the preparation of a drug, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished drug; “ministry” means the Ministry responsible for health; “orphan drug” means a drug intended for use in a rare disease; “pharmaceutical facility” means any premises from which any drugs are stored, manufactured, sold, dispensed or otherwise supplied directly to the public by retail or wholesale; “product licence” means the legal document granted by the competent authority, under regulation 5, authorising the commercialisation of a product; 134 Food and Drugs “public health standards” means standards developed to promote and protect the health of people and the communities where they live, learn, work and play. Registration of Drugs