National Medicines Regulatory Authority Act 2015 · As enacted · Part IV · General
39. Functions of NMQAL
Official English translation. Where it differs from the Sinhala or Tamil text, the Act itself says which text prevails.
Official translationFrom Department of Government Printing, unchanged
The functions of the NMQAL shall be -
the testing of the quality of medicines, medical devices or borderline products submitted by the Authority including the articles -
submitted with the application for registration;
collected at the entry to the country;
submitted as a complaint by users;
collected during the post marketing surveillance by the Authority;
submitted by the Authority for any reason other than the reasons specified above;
to function, as an additional approved
Analyst, when the circumstances so require;
to coordinate with laboratories local or overseas when their services are deemed necessary as decided by the Authority;
to carry out research projects pertaining to quality assurance of medicines, medical devices or borderline products.
The NMQAL shall carry out any other functions as may be requested by the Authority and the Department of
Health through the Authority.
The NMQAL shall carry out any testing or analysis of an article submitted to the NMQAL strictly according to the quality and standards guidelines as may be introduced by the Authority, from time to time.
The NMQAL shall submit the analysis report on the quality and standards of the article submitted within the time period stipulated by the Authority.
For the purposes of this part of this Act “article”
includes any article of medicine, medical device, borderline product or investigational medicinal product.
Part V
General
Part VI
Rules and Regulations
Part VII
Repeals and Transitional Provisions
Part VIII