A 24
[Subsidiary]
L.N. 137/78.
Ninth Schedule.
L.N. 137/78.
L.N. 369/80.
Clinical trials and medicinal tests.
L.N. 137/78. L.N. 369/80. Ninth Schedule.
Eighth Schedule, Form 12.
Ninth Schedule.
L.N. 369/80.
Definition of "pharmaceutical product" and "substance" for the purposes of this Part.
L.N. 137/78.
Duplicate certificates.
L.N. 369/80.
CAP. 138]
Pharmacy and Poisons Regulations
[1987 Ed.
(6) The Committee shall advise the applicant whether the pharmaceutical product or substance appears in the Poisons List and if so, under which classification.
(7) A registration certificate issued under paragraph (5) shall be renewable on payment of the fee prescribed in the Ninth Schedule.
(8) The Committee may deregister a pharmaceutical product or substance if it considers it to be in the public interest to do so.
(8A) Where the Committee refuses to register or deregisters a pharmaceutical product or substance it shall forward to the applicant or permit holder, as the case may be, a notice of refusal or of deregistration and shall state in such notice its reasons for refusal to register or for deregistration.
(9) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision.
(10) [Deleted, L.N. 369/80]
(11) Any change in the particulars referred to in paragraph (3) shall be reported to the Committee within 14 days.
36A. [Spent]
36B. (1) For the purpose of conducting a clinical trial on human beings or a medicinal test on animals application shall be made in writing to the Committee and shall be accompanied by the fee prescribed in the Ninth Schedule.
(2) A sample of the product or substance and a copy of the protocol for the trial or test shall accompany the application.
(3) The Committee may issue a clinical trial certificate or medicinal test certificate in the form prescribed in the Eighth Schedule valid for a period not exceeding 2 years on payment of the fee prescribed in the Ninth Schedule.
(4) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision.
36C. For the purposes of this Part "pharmaceutical product" and "substance" have the meaning assigned to "pharmaceutical product" and "medicine" in the Ordinance.
36D. (1) The Committee may issue a duplicate of any certificate issued under this Part if the Committee is satisfied that the original certificate has been lost or destroyed or that for other good reason such duplicate ought to be issued.