Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules, 2019- No. 130 of 2019

These Regulations are made pursuant to the Pharmacy and Poisons Act. The Rules apply to medicinal substances which are parallel imported and distributed on the Kenyan market, with well specified exceptions. The Regulations provide that a person shall not import a medicinal substance unless the person is incorporated as a limited liability company. Additional requirements include that the person has a certificate of parallel importation to import the medicinal substance, that the substance has a valid registration in Kenya and the substance has a valid market authorization in its country of origin. The Rules provide extensively for the procedure for the application of the certificate of parallel importation and the parallel import licence. The Rules further provide for the packaging and labeling of the imported items and provides for the power of authorized officers to carry out the inspection of premises and consignments of medicinal substances at the port of entry.