As enacted

Contents

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

62. Issuing of certificate of registration

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

(1)

(a)

The Authority shall on registration of any medicine, issue a Certificate of Registration to the applicant who shall, hereinafter in this part of this Act, be referred to as “the holder of certificate”.

(b)

The Authority may grant full or provisional registration in respect of the medicine and the conditions for each type of registration shall be prescribed.

(c)

The period of registration granted shall be decided by the Authority as appropriate.

(2)

The Certificate of Registration shall include the purpose for which the registration is granted, its period of validity and the terms and conditions applicable thereto.

(3)

Upon obtaining the Certificate of Registration, the holder of certificate shall enter into an agreement with the

Authority to inform the Authority of any new developments of the medicine including the changes to indications, side effects, cautions, contra-indications, new recommendations by regulatory bodies in other countries, strictures, cancellations within a stipulated time period upon such facts and information being revealed.

Read on from s 63

Part V