[Section 15 heading substituted by section 24 of Notice No. 19, GG 39585, dated 8 January 2016]
| (1) | Every application for the registration of a medicine, medical device or IVD shall be submitted to the Chief Executive Officer in the prescribed form and shall be accompanied by— |
| (a) | the prescribed particulars; |
| (b) | samples of the relevant medicines; |
| (c) | where practicable, samples of medical devices or IVDs; and |
| (d) | the prescribed registration fee. |
| (2) | As soon as possible after receipt by the Chief Executive Officer of an application contemplated in subsection (1), he or she shall inform the applicant in writing that the application is being considered. |
(3)
| (a) | If after consideration of any such application and after any investigation or enquiry which it may consider necessary the Authority is satisfied that the medicine, medical device or IVD in question— |
| (i) | is suitable for the purpose for which it is intended; |
| (ii) | complies with the prescribed requirements; and |
| (iii) | is safe, efficacious and of good quality and, in the case of a medical device and IVD, performs as intended; |
[Section 15(3)(iii) substituted by section 8(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (iv) | [Section 15(3)(a)(iv) deleted by section 8(b) of Notice No. 19, GG 39585, dated 8 January 2016] |
the Authority shall issue the applicant with a certificate of registration to that effect.
| (b) | If the Authority is not satisfied as contemplated in paragraph (a), it shall cause the applicant to be notified in writing of the reasons why it is not so satisfied and cause the applicant to be informed that he or she may within a period of 30 days after the date of the notification furnish the Chief Executive Officer with his or her comments on the Authority’s reasons for not being so satisfied. |
| (c) | If no such comments are submitted by the applicant within the said period, or if after consideration of any comments so submitted the Authority is still not satisfied as aforesaid, it shall reject the application. |
[Section 15(3)(c) substituted by section 8(c) of Notice No. 19, GG 39585, dated 8 January 2016]
| (4) | Every medicine, medical device or IVD shall be registered under such name as the Authority may approve. |
| (5) | The Chief Executive Officer shall allocate to every medicine, medical device or IVD registered under this Act a registration number which shall be recorded in the register opposite the name of such medicine, medical device or IVD and which shall be stated in the certificate of registration issued in respect of such medicine, medical device or IVD. |
| (6) | Any registration under this section— |
| (a) | may be made subject to such conditions as may be determined by the Authority; and |
| (b) | shall in the case of medicines, be valid for a period of five years. |
| (7) | No condition shall be imposed under subsection (6) whereby the sale of the medicine in question by any person other than a pharmacist is prohibited or until after the applicant has in writing been notified by the Chief Executive Officer that the imposition of such condition is contemplated and invited to submit written representations to the Authority in regard to the matter. |
| (8) | If no such representations are lodged by the applicant concerned within a period of 30 days after the receipt by him or her of any notification referred to in subsection (7), or if after consideration of any such representations the Authority is still of the opinion that the condition in question should be imposed, the Authority shall register the medicine, medical device or IVD concerned subject to the said condition. |
| (9) | Notice of the rejection of an application for registration under this section in respect of a medicine, medical device or IVD referred to in subsection (3) of section 14 shall be given in the Gazette by the Chief Executive Officer. |
| (10) | The Chief Executive Officer shall as soon as possible after the date of expiry of the appropriate period referred to in section 14(3) publish in the Gazette the prescribed particulars in respect of all applications for registration received by him or her prior to such date. |
[Section 15 substituted by section 8 of Notice No. 434, GG 32148, dated 21 April 2009]
