As enacted

Contents

National Medicines Regulatory Authority Act 2015 · As enacted · Part I · Establishment of the Authority

14. Powers and functions of theAuthority

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

The powers and functions of the Authority shall be to :-

(a)

decide on classifying a product as a medicine, medical device, borderline product or any other product;

(b)

authorize registration and licensing of medicines, medical devices, borderline products and investigational medicinal products or cancel or suspend any such registration or licence in terms of this Act;

(c)

regulate the registration, licensing, manufacture, importation, storage, re-packing, transportation, distribution, sale, advertising, promotion, recall and disposal of medicines, medical devices, borderline products or investigational medicinal products;

(d)

authorize registration and regulation of Pharmacies and medicines stores;

(e)

issue licences for manufacture, import, storage, distribution, transport and sale of medicines, medical devices, borderline products or investigational medicinal products and to cancel such licences in terms of this Act;

(f)

appoint sub-committees as may be necessary for the effective discharge of the functions of the

Authority;

(g)

grant approval for the custom clearance of consignments of medicines, medical devices, borderline products, raw materials, packing materials, machinery or laboratory material needed for local manufacture of medicines, medical devices, borderline products or investigational medicinal products subject to the provisions of this

Act and any other written law;

(h)

conduct awareness programmes in relation to medicines, medical devices and borderline products and post market surveillance on the quality and safety of medicines, medical devices, borderline products and investigational medicinal products which are registered and licensed under this Act;

(i)

monitor the registration and licensing process and the usage of medicines, medical devices, borderline products or investigational medicinal products which are registered and licensed under this Act for adverse reactions through use thereof, and to take immediate and necessary action in such an instance;

(j)

collect data on quantities of medicines, medical devices, borderline products or investigational medicinal products imported under licences;

(k)

collect data on utilization of medicines, medical devices, borderline products and investigational medicinal products in Sri Lanka, including data on expenditure of industry and trade, relating to promotional activities;

(l)

advise the Minister on matters which are required to be prescribed;

(m)

acquire, hold, take or give on lease or hire, mortgage, pledge, sell or otherwise dispose of, any movable or immovable property;

(n)

charge fees where necessary and appropriate in the discharge of its functions;

(o)

recognize and appoint other local or overseas laboratories for testing of any medicine, medical device or borderline product as may be deemed necessary;

(p)

follow Good Regulatory Practices (GRP) as prescribed in regulations;

(q)

determine the initial price of medicines, medical devices and borderline products and advise the

Minister on subsequent price revisions;

(r)

provide information pertaining to the functions of the Authority to the stakeholders and general public; and

(s)

issue, review and update guidelines, recommendations, directives and rules as applicable to medicines, medical devices and borderline products.

Part II