GAZETTE NOTICE NO. 1880

IT IS notified that Form 1: Application for Registration of a herbal or complementary medicinal substance has been revised in accordance with the provisions of the Pharmacy and Poisons Act (Cap 244), The Pharmacy and Poisons (Registration of Drugs) Rules, Legal Notice Number 192 of 2010. The template application form below prescribes the minimum information required for submission of dossiers for registration of a herbal or complementary medicinal substance seeking marketing authorization in Kenya. The dossiers should be submitted to the following address: The Registrar, Pharmacy and Poisons Board Lenana Road, P. O. Box 27663-00506, NAIROBI, KENYA For purposes of submission to PPB, an application for registration of herbal and complementary product shall include: One duly filled application submitted as an electronic copy including their supporting documents - see Annex I: Application Form For Registration Of Herbal And Complementary Medicinal Substance below (a) Three (3) samples of the commercial pack(s). (b) Payment of requisite application fees described in the guideline document for herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board. (c) Any other information required and described in the guideline document for herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board. ANNEX I: APPLICATION FORM FOR REGISTRATION OF HERBAL AND COMPLEMENTARY MEDICINAL SUBSTANCE (to be submitted as an electronic copy) SECTION 1: PARTICULARS OF THE APPLICANT (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) SECTION 2: PARTICULARS OF THE HERBAL AND COMPLEMENTARY MEDICINAL SUBSTANCE (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) SECTION 3: PARTICULARS OF THE MANUFACTURER(S) AND ACTIVITY DONE AT THE MANUFACTURING SITE(S) (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) SECTION 4: COMPOSITION OF THE PRODUCT (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) 4.1 List all active pharmaceutical ingredient(s) used in the particular herbal or complementary medicinal substance in the table below. Scientific or Botanical Name Common Name or Synonym Part of Plant used Quality Specification (USP, BP, or In house) Quantity per dosage unit Major Chemical Constituent(s) 4.2 List all non active ingredient(s) used in the particular herbal or complementary medicinal substance in the table below. Scientific or Botanical Name Common Name or Synonym Part of Plant used (where applicable) Specification Quantity per dosage unit Reason for inclusion SECTION 5: QUALITY SPECIFICATION AND ANALYTICAL PROCEDURES FOR ALL RAW MATERIALS USED IN THE PRODUCT (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) SECTION 6: QUALITY SPECIFICATION AND ANALYTICAL PROCEDURES FOR THE FINISHED PRODUCT (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) 21st March, 2014 THE KENYA GAZETTE SECTION 7: QUALITY SPECIFICATION AND ANALYTICAL PROCEDURES FOR THE PACKAGING MATERIAL USED IN THE FINISHED PRODUCT (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) SECTION 8: DETAILS OF THE MANUFACTURE AND PACKAGING OF THE FINISHED PRODUCT (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) SECTION 9: STABILITY STUDIES OF THE FINISHED PRODUCT (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) SECTION 10: PHARMACOLOGICAL AND TOXICOLOGICAL INFORMATION OF THE FINISHED PRODUCT (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) SECTION 11: ANY OTHER REFERENCE TO SUPPORT THE APPLICATION (as described in the guideline document for registration of a herbal or complementary medicinal substance issued by the Pharmacy and Poisons Board from time to time) SECTION 12: DECLARATION BY AN APPLICANT which must be signed, dated and authenticated by an Official stamp. No received without properly authenticated declaration. • I, the undersigned certify that all the information in this form and accompanying documentation is correct, complete and true to the best of my knowledge. • I further confirm that the information referred to in my application file is available for verification during GMP inspection. • I also agree that I am obliged to follow the requirements of the Pharmacy and Poisons Board which are related to herbal and complementary medicinal substance. • I also agree that the undersigned has not marketed or advertised this product in Kenya and will follow the PPB requirements for advertisements of medicines • I also agree that the undersigned will implement a Post-Market Surveillance plans for this product in accordance with PPB requirements • I also consent to the evaluation of information provided to the Pharmacy and Poisons Board. Name: ………… ………………………………………..............……… Position in the company: …………………………………...............… Signature and Date: ………… ……………………..............………… Official stamp: ………… ……………………………...........………… Dated the 8th January, 2014. K. C. KOSKEI, MR/4648206 Registrar.