The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, Legal Notice no. 100 of 2022.

These Rules, made in exercise of the power conferred by section 44(1) of the Pharmacy and Poisons Act (cap. 244) of 1957, provide for control of import, manufacturing and selling of a health product or technology. The Rules concern: good manufacturing practice certificate; immunogenic substance; medicinal product and medicinal substance, whose origin may be human, animal, vegetable or chemical and includes animals, animal secretions, part of plants, vegetable secretions; vaccine. Matters covered by these Rules include: application for registration of health product and technology, accompanied by: a proposed label for use on the health product, a copy of a certificate of analysis from a quality control laboratory, a copy of the marketing authorisation, available data on the quality, safety, efficacy and performance of the health product or technology, a valid licence to deal in poisons for mining or agricultural purposes; specific information to be provided on the products; validity and renewal of a certificate of registration; change in the product details; provisional certificate of registration in case of a threat to human or animal life or health; procedure for authorisation of unregistered health product or technology, including human or animal pharmacological and clinical data related to the health product; specific measures in case the safety of any patient or animal is compromised, including withdrawal of the authorisation.