Section 36: Licence for manufacture

36. Licence for manufacture (1) No person shall, unless he holds a licence, manufacture any pharmaceutical product. (2) Any person who wishes to obtain a licence under this section shall— (a) make a written application to the Board; and (b) furnish, in support of his application— (i) the formula of each pharmaceutical product to be manufactured; (ii) the technical description of the production process; (iii) details of all quality control; and (iv) such other information or documents as the Board may require. (3) The Board may, on receipt of an application under subsection (2), grant the application on payment of the prescribed fee and on such conditions as it thinks fit or reject the application. (4) Where the Board rejects an application under subsection (3), it shall notify the applicant of the reasons for its decision. (5) No application for a licence to manufacture therapeutic substances shall be granted unless— (a) there are adequate facilities for manufacture of sterile preparations; (b) there is appropriate quality control of any therapeutic substance used and of the finished product; and [Issue 1] P8 – 20 Revised Laws of Mauritius (c) the manufacture takes place under the supervision of a pharmacist, a pharmacologist or a chemist who proves to the satisfaction of the Board that he has adequate experience in the manufacture of the therapeutic substances. (6) Every licence issued under this section shall be valid for a period of one year as from the date specified in the licence and may be renewed annually on payment of the prescribed fee. (7) Where the Board is satisfied that a licensee has contravened this Act or any condition attached to his licence, it may, by notice in writing, require the licensee within 15 days from the date of service of the notice to show cause why his licence ought not to be revoked and if the Board is satisfied that, having regard to all the circumstances of the case, it is expedient to do so, it may revoke his licence.