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Contents

Part I · Establishment of the Authority

3. Objects of the Authority

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

The objects of the Authority shall be to –

(a)

ensure the availability of efficacious, safe and good quality medicines, efficacious, safe and good quality medical devices and efficacious, safe and good quality borderline products to the general public at affordable prices;

(b)

function as the central regulator for all matters connected with the registration, licensing, cancellation of registration or licensing, pricing, manufacture, importation, storage, transport, distribution, sale, advertising and disposal of medicines, medical devices and borderline products;

(c)

ensure that all activities related to registration, licensing and importation of medicines, medical devices, borderline products and investigational medicinal products are carried out in a transparent, sustainable and equitable manner;

(d)

encourage the manufacturing of good quality medicines in Sri Lanka with a view to assuring the availability of essential medicines at affordable prices;

(e)

promote the safe and rational use of medicines, medical devices and borderline products by health care professionals and consumers;

(f)

recommend appropriate amendments to relevant laws pertaining to medicines, medical devices and borderline products;

(g)

educate the general public, health care professionals and all stakeholders on medicines, medical devices and borderline products;

(h)

regulate the promotion and marketing of medicines, medical devices and borderline products;

(i)

regulate the availability of the medicines, medical devices and borderline products;

(j)

conduct post marketing surveillance on quality, safety and adverse reaction of the medicines, medical devices and borderline products; and

(k)

regulate all matters pertaining to the conduct of clinical trials in Sri Lanka.

Part II

Appointment of Chief Executive Officer and Staff of the Authority

Part III

Finance

Part IV

General

Part V

General

Part VI

Rules and Regulations

Part VII

Repeals and Transitional Provisions

Part VIII

Interpretation