Section 36C: Registration of locally manufactured pharmaceutical

36C. Registration of locally manufactured pharmaceutical products (1) (a) A person who wishes to register a locally manufactured pharmaceutical product shall make an application to the Board in the prescribed form. (b) An application made under paragraph (a) shall be accompanied by such non-refundable processing fee as may be prescribed. (2) The Board shall, on receipt of an application made under subsection (1), forthwith refer the application to the Trade and Therapeutics Committee for its recommendations. (3) The Trade and Therapeutics Committee shall examine the application under subsection (1) and shall submit its recommendations not later 21 days after the application is referred to it. (4) The Board may, not later than 7 days after the Trade and Therapeutics Committee submits its recommendations grant or reject the application. (5) Where the Board grants an application, it shall, on payment of the prescribed registration fee, register the locally manufactured pharmaceutical product and issue to the applicant a certificate of registration in such form as may be prescribed and on such terms and conditions as it may determine. 66 Acts 2020 (6) A certificate of registration which is issued under this section shall be valid for a period of one year as from the date specified on the certificate of registration and may be renewed annually on payment of the prescribed fee. (7) The holder of a certificate of registration of a locally manufactured registered pharmaceutical product shall inform the Board and pay such prescribed fee for any change in the characteristics and extension in range of the registered pharmaceutical product. (8) The Board may exempt any locally manufactured pharmaceutical product from registration.