As enacted

Contents

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

102. Application for Registration of a borderline product

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

(1)

Any person who wishes to import, sell, manufacture, prepare or distribute any borderline product shall make an application for the registration of that borderline product in the prescribed form to the Authority.

(2)

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

(3)

(a)

The Authority shall maintain a register in which every application received for the registration and licensing of a borderline product 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 the application together with the sample of the borderline products and all particulars, available -

(a)

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

and

(b)

to the NMQAL or where necessary any other laboratory for testing of the quality of the borderline product.

(5)

The Authority shall inform the applicant in writing of the receipt of the application.

(6)

The Minister may make regulations -

(a)

setting out the procedures to be followed, by the

BPEC 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 BPEC 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 BPEC and the

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

(b)

The BPEC 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 103

Part V