As enacted

Contents

National Medicines Regulatory Authority Act 2015 · As enacted · Part IV · General

59. Application for Registration of a medicine

Official English translation. Where it differs from the Sinhala or Tamil text, the Act itself says which text prevails.

(1)

Any person who intends to manufacture or import any medicine shall make an application for the registration of that medicine in the prescribed form to the Authority.

(2)

The application shall be accompanied by the prescribed particulars, the samples of the medicine and the prescribed fee.

(3)

(a)

The Authority shall maintain a register in which every application received for the registration of a medicine shall be recorded.

(b)

The particulars to be entered in such register shall be as prescribed.

(4)

The Authority shall upon receipt of an application submit that application together with the sample of the medicine and all particulars, available -

(a)

to the MEC, for the evaluation of the application and the medicine considering the need to ensure the availability of efficacious, safe and good quality medicine relevant to the healthcare needs of the public at an affordable price; and

(b)

to the NMQAL, for testing of the quality of the medicine.

(5)

The Authority shall inform the applicant in writing that the application has been received and submitted for evaluation and testing.

(6)

The Minister may make regulations -

(a)

setting out the procedures to be followed, by the MEC and the NMQAL in their respective evaluation and testing processes;

(b)

specifying –

(i)

the time-limits in conducting such testing or evaluation;

(ii)

the manner in which the MEC to conduct its meetings and the procedure to be followed at such meetings; and

(iii)

the matters which should be included in the reports to be submitted.

(7)

(a)

The Authority may require the MEC and the

NMQAL to finalize the evaluation or testing of a medicine within a specified time period considering the urgency of such medicine for the national health.

(b)

The MEC and the NMQAL shall within the time limits specified submit their reports to the Authority unless there are compelling reasons for any delay.

Read on from s 60

Part V