GAZETTE NOTICE NO. 5546

IT IS notified for the general information of the public that the Cabinet Secretary for Health in consultation with the Pharmacy and Poisons Board (“the Board”), has pursuant to the provisions of Section 8 of the Statutory Instruments Act, 2013, prepared a Regulatory Impact Assessment on the impacts and likely impact on the community of the proposed Regulations that is intended for the operationalization of the Pharmacy and Poisons Act (Cap. 244). The proposed rules are: (a) The Pharmacy and Poisons (Guidelines for the conduct of Clinical Trials) Rules, 2022; (b) The Pharmacy and Poisons (Transportation of Pharmaceuticals) Rules, 2022; (c) The Pharmacy and Poisons (Pharmaceutical Waste Management) Rules, 2022; (d) The Pharmacy and Poisons (Pharmacovigilance and Post- Market Surveillance) Rules, 2022; (e) The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022; and (f) The Pharmacy and Poisons (Amendment) Rules, 2022. The Regulatory Impact Statements and proposed Rules are freely available on the Board’s website accessible via: https://web.pharmacyboardkenya.org/ and also, on request, at the Board’s offices along Lenana Road, Nairobi during working hours. Any person who is likely to be affected by the proposed Rules may submit a written memorandum on the Regulatory Impact Statements and the proposed Rules within fourteen (14) days from the date of this notice. The memorandum should be addressed to: Cabinet Secretary Ministry of Health Afya House, Cathedral Road P.O. Box 30016–00100 Nairobi, Kenya cshealth2015@gmail.com or Pharmacy and Poisons Board P.O. Box 27663–00506 Nairobi feedback@pharmacyboardkenya.org The public is also notified that they can visit the Board’s offices and seek clarification on specific issues regarding the proposed Rules and the Regulatory Impact Statements between 8.00 a.m. and 5.00 p.m. during official working days. MUTAHI KAGWE, Cabinet Secretary for Health. 20th May, 2022 THE KENYA GAZETTE