As enacted

Contents

National Medicines Regulatory Authority Act 2015 · As enacted · Part VI · Rules and Regulations

142. Regulations

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

(1)

The Minister may make regulations in respect of any matter required by this Act to be prescribed or in respect of which regulations are authorized by this Act to be made.

(2)

In particular and without prejudice to the generality of the powers conferred by subsection (1), the Minister may make regulations in respect of all or any of the following matters:-

(a)

declaring that any medicine, medical device or borderline product or class of medicine, medical device or borderline product is adulterated if any prescribed substance or class of substance is present or has been added to or extracted from or omitted in, that medicine, medical device or borderline product;

(b)

declaring that any medicine, medical device or borderline product is safe for general use or not safe for general use;

(c)

pricing of medicines, medical devices and borderline products;

(d)

the labeling and packaging and the offering, exposing and advertising for sale of medicine, medical device or borderline product;

(e)

prescribing the size, dimensions, fill and other specifications of packages of, medicine, medical device or borderline product;

(f)

the use of any substance as an ingredient in medicine, medical device or borderline product to prevent the user or purchaser from being deceived or misled as to its quality, character, value, composition or to prevent injury to the health of the user or purchaser;

(g)

the standards of composition, strength, potency, purity, quality or other property of medicine, medical device or borderline product;

(h)

the method of preparation, the manufacture, preservation, packaging, storing and testing of any medicine in the interest of, or for the prevention of injury to, the health of the user or purchaser;

(i)

the persons to whom, the circumstances in which, and the terms and conditions subject to which, licences and registrations under this

Act may be granted or refused; and

(ii)

the manner and mode in which applications for licences and registrations under this Act may be made and dealt with;

(j)

requiring persons who manufacture or sell any medicine, medical device or borderline product to furnish information and maintain books and records;

(k)

the registration and regulation of Pharmacies and drug stores;

(l)

the terms and conditions for storage and transport of medicine, medical device, borderline product or investigational medicinal product;

(m)

the disposal of medicine, medical device, borderline product or investigational medicinal product;

(n)

the specification of recalling procedure of medicines, medical devices and borderline products and composition of committees;

(o)

the conditions relating to importers and market authorization holders;

(p)

the procedure for parallel imports and licensing for non-commercial use by the Government;

(q)

Forms to be used for the registration, renewal and licensing under this Act and the regulations made thereunder;

(r)

prohibition and restrictions relating to the sale and transport for sale of any adulterated medicine or borderline product;

(s)

prescribing the medicines, medical devices or borderline products prohibited under the Act;

(t)

the distribution and the conditions of distribution of sample of any medicine, medical device, borderline product or investigational medicinal product;

(u)

the mode and manner in which any medicine, medical device or borderline product shall be registered, the terms and conditions applicable to such registration and licensing, the fees to be levied for such registration or licensing;

(v)

the manner in which the Appeal Committee shall function and procedure of hearing Appeals;

(w)

the standards of shelf-life for manufacture of medicines, medical devices or borderline products;

(x)

procedure to be followed by the MEC, MDEC and

BPEC in the conduct of its functions and the transaction of its business;

(y)

the procedure of inquiries;

(z)

the procedure to be followed by MEC, MDEC and

BPEC for the respective evaluations and matters which should be included in reports;

(aa)

the review and revision of all guidelines formulated under this Act;

(bb)

the procedure for issuing of lot release certificate by Medical Research Institute in relation to vaccines and sera;

(cc)

evaluation of advertisements and other promotional material of manufacturers, importers, distributors and retailers of medicines, medical devices and borderline products;

(dd)

regulation of promotional activities pertaining to medicines, medical devices, borderline products and investigational medicinal products;

(ee)

any other matters as may be necessary for the purposes of achieving the objects and discharging the functions of the Authority.

(3)

Every regulation made by the Minister shall be published in the Gazette and shall come into operation on the date of such publication or on such later date as may be specified in such regulation.

(4)

Every regulation made by the Minster, shall not later than three months after its publication in the Gazette, be brought before Parliament for approval. Any regulation which is not so approved shall be deemed to be rescinded as from the date of such disapproval, but without prejudice to anything previously done thereunder.

(5)

A notification of the date of such disapproval shall be published in the Gazette.

Read on from s 143

Part VII

Repeals and Transitional Provisions

Read on from Part VII

Part VIII

Interpretation

Read on from Part VIII