Grant or refusal of product licence

(1) The competent authority may grant a product licence for any drug if the person seeking the product licence has applied in writing to the competent authority, and satisfies the requirements for drug registration under this regulation. (2) Where the competent authority grants a product licence, the competent authority shall provide the applicant with a registration code for the drug. (3) The competent authority shall allow an applicant six months to satisfy the requirements for the registration of a drug. (4) The competent authority shall refuse to grant a product licence if– (a) an applicant fails to satisfy the requirements within the time stated under subregulation (3); (b) the risk benefit analysis is unfavourable; (c) there is insufficient justification for the therapeutic efficacy; (d) the drug does not have the quali-quantitative composition declared or its quality is compromised; Food and Drugs 137 (e) the information submitted during the request is erroneous or does not comply with the Act or the provisions of the Antibiotics Act, Chemists and Druggists Act and Misuse of Drugs Act, or CAP. 33. CAP. 3:11. CAP. 103. (f) the applicant does not comply with the requirements of any Act specified in paragraph (e).