Pharmacy and Poison (Registration of Drugs) Rules (Cap. 244)

[Rev. 2012] [Issue 1] P15 - 96 PHARMACY AND POISONS (REGISTRATION OF DRUGS) RULES ARRANGEMENT OF RULES Rule 1. Citation. 2. Interpretation. 3. Control of the manufacture, etc., of drugs. 4. Application for registration of drug. 5. Fees. 6. Issue of certificate of registration. 7. Duration, etc., of certificate of registration. 8. Suspension or revocation of certificate of registration. 9. Conditions for registration of a new drug. 10. Inspection of premises. 11. Offences and penalties. SCHEDULE – FORMS [Rev. 2012] P15 - 97 [Issue 1] PHARMACY AND POISONS (REGISTRATION OF DRUGS) RULES [L.N. 147/1981, L.N. 142/1991, L.N. 192/2010.] 1. Citation These Rules may be cited as the Pharmacy and Poisons (Registration of Drugs) Rules. 2. Interpretation In these Rules, “drug” means a substance or mixture of substances which can be used for any of the following purposes— (a) treating, preventing or alleviating symptoms of disease; (b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition; or (c) otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily and whether by way of terminating, reducing, postponing or increasing or accelerating the operation of that function, in human beings and animals and includes a substance which can be used as a contraceptive or for the purpose of inducing anaesthesia; but does not include a product prepared by a pharmacist in his pharmacy and dispensed by him without promotion, blood, blood plasma and blood preparations containing cellular elements of blood, or substances such as dental fillings and plates, or surgical preparations such as catgut and plaster of Paris bandages. “cosmetics” includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair, eyes or teeth, and includes deodorants and perfumes; “import” includes parallel importation; and “parallel importation” means the importation into Kenya of patented drugs under section 58(2) of the Industrial Property Act, 2001. [L.N. 192/2010, r. 3.] 3. Control of the manufacture, etc., of drugs No person shall import, manufacture for sale or sell any drug in Kenya unless that drug has been registered and listed in accordance with the provision of these Rules. [L.N. 192/2010, r. 4.] 4. Application for registration of drug (1) An application for registration of a drug shall be in Form 1 in the Schedule. (1A) An application for registration of parallel imported drugs, poisons, listing of herbal, complementary medicines and cosmetics shall be in form 1 in the Schedule. (2) In addition to the information required to be furnished in the prescribed form the applicant shall furnish such further information and material as may be required by the Board for the proper evaluation of the drug in respect of which the application is made. (3) An application for renewal of registration of a drug under rule 7 shall be in Form 1A set out in the Schedule. [L.N. 142/1991, r. 2, L.N. 192/2010, r. 5.] [Rev. 2012] [Issue 1] P15 - 98 (1) An application made under rule 4 shall be accompanied by the following fees— (a) five thousand shillings if the drug required to be registered has been manufactured outside Kenya; and (b) one thousand shillings if the drug required to be registered has been manufactured in Kenya. (2) If the registration is being renewed the applicant shall pay the following fees— (a) one thousand shillings in respect of a drug manufactured outside Kenya; and (b) five hundred shillings in respect of a drug manufactured in Kenya. (3) A fee of five hundred shillings shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost and such copy shall bear the words “DUPLICATE COPY”. 6. Issue of certificate of registration (1) The Board shall consider the application made under rule 4, and, if it is satisfied of the safety, efficacy, quality and economic value of the drug, shall register the drug and issue a certificate of registration which shall be in Form 2 in the Schedule. (1A) The Board shall consider the application made under subrule 4(1)(a) and may, if it is satisfied of the safety, quality, efficacy and economic value of the drugs, register the same, and issue a certificate of registration which shall be in Form 2. (2) The Board may, while considering a drug for registration under paragraph (1), approve the details as supplied by the applicant or approve it with such amendments as it may deem appropriate in respect of the following particulars— (a) the name under which the drug may be sold; (b) the labelling; (c) the statement of the representations to be made for the promotion of the drug in respect of— (i) the claim to be made for the drug; (ii) the route of administration; (iii) the dosage; (iv) the contra-indications, the side effects and precautions, if any; and (v) the package size. (3) If the Board is not satisfied as to the safety, efficacy, quality or economic value of the drug, it may, after providing an opportunity to the applicant to be heard, reject the application for the registration of the drug and inform the applicant the reasons for rejection in writing. [L.N. 192/2010, r. 6.] 7. Duration, etc., of certificate of registration (1) A certificate of registration issued under these Rules shall, unless earlier suspended or revoked, be in force for a period of five years from the date of issue and may thereafter be renewed for periods not exceeding five years at any one time. (2) If an application for renewal is made before the expiration of the period of validity of a certificate of registration the certificate shall remain in force until the application is [Rev. 2012] P15 - 99 [Issue 1] approved; except that where the application for renewal is made after the expiration of the period of validity of the certificate of registration the application shall be considered as a fresh application and the provision of rule 6 shall apply accordingly. 8. Suspension or revocation of certificate of registration (1) The Board may suspend or revoke a certificate of registration issued under these Rules for such period as the Board may determine. (2) The powers conferred by subrule (1) shall not be exercised by the Board in respect of any certificate of registration except on one or more of the following grounds— (a) the matters stated in the application on which the certificate of registration was granted were false or incomplete in a material particular; (b) that a provision of the certificate of registration has to a material extent been contravened by the holder of the certificate; or (c) that the premises on which, or on part of which, drugs are manufactured, assembled or stored by or on behalf of the holder of the certificate of registration are unsuitable for the manufacturing, assembling or storage of drugs; or (d) that new information has been discovered by the Board which renders the drugs unsafe or dangerous. 9. Conditions of registration of a new drug (1) The Board shall, before registering a new drug for which the research work has been conducted in another country and its efficacy, safety, and quality established in that country, require an investigation on the pharmaceutical, pharmacological and other aspects of the drug to be conducted and clinical trials to be made which are necessary to establish its quality and where applicable the biological availability and its safety and efficacy to be established under local conditions. (1A) Any person wishing to carry out a clinical trial in the country shall apply to the Board for approval before engaging in such study involving investigational products. (1B) An application under paragraph (1A) shall be accompanied by the fees set out in Part B of the Second Schedule. (2) Notwithstanding subrule (1), the Board may register a new drug and require the investigations and clinical trials specified in subrule (1) to be conducted after its registration. (3) The Board may, if in its opinion it is necessary to do so in the interests of public health, register a new drug for a period of two years. [L.N. 192/2010, s. 7.] (1) The Board shall maintain a register containing a record of all the drugs registered. (2) There shall be payable by entities whose drugs are registered a retention fee in the amount specified in Part A of the Second Schedule. [L.N. 192/2010, s. 8.] 10. Inspection of premises The Board may, before issuing a certificate of registration under these Rules, cause the premises in which the manufacturing of the drug is proposed to be conducted to be inspected by inspectors appointed for that purpose, and the inspectors shall have powers to enter the premises and inspect the plant and the process of manufacture intended to be employed in the manufacturing of the drug and make a report to the Board. [Rev. 2012] [Issue 1] P15 - 100 11. Offences and penalties A person who contravenes any of the provisions of these Rules shall be guilty of an offence and shall be liable to a fine not exceeding six thousand shillings or to a term of imprisonment not exceeding six months or to both such a fine and such imprisonment. FIRST SCHEDULE [L.N. 147/1981, L.N. 192/2010, r. 9. ] [Rev. 2012] P15 - 101 [Issue 1] [Rev. 2012] [Issue 1] P15 - 102 SCHEDULE [Rev. 2012] P15 - 103 [Issue 1] [Rev. 2012] [Issue 1] P15 - 104 [Rev. 2012] P15 - 105 [Issue 1] SECOND SCHEDULE [L.N. 192/2010, rr. 52(b), 9(1B).]