As enacted

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National Medicines Regulatory Authority Act 2015 · As enacted · Part VIII · Interpretation

146. Interpretation

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

In this Act, unless the context otherwise requires:—

“adulterated” means the addition of any substance to or subtraction of any constituent from a medicine, medical device or borderline product so as to affect its quality, composition or potency;

“advertisement” includes any representation by any means whatsoever, for the purpose of promoting directly or indirectly the manufacture, sale or disposal of any medicine medical device or borderline product;

“article” means —

(a)

any medicine, medical device or borderline product;

(b)

anything used or capable of being used for the manufacture, preparation, preservation, packaging or storing of any medicine, medical device or borderline product ; and

(c)

any labeling or advertising material;

“bioequivalence” means two pharmaceutically equivalent or pharmaceutical alternative products having their bio availabilities after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, will be essentially the same. This is considered demonstrated if the 90% confidence intervals (90% CI) of the ratios for AUC0-t and

Cmax between the two preparations lie in the range 80.00 – 125.00%;

“biowaiver” means a regulatory approval process when the application (dossier) is approved on the basis of evidence of equivalence other than an in vivo bioequivalence test. For solid oral dosage forms, the evidence of equivalence is determined on the basis of an in vitro dissolution profile comparison between the multisource and the comparator product;

“borderline products” means the products having combined characteristics of medicines and foods, medicines and medical devices or medicines and cosmetics and in deciding whether a product is a borderline product the following shall be taken into consideration:-

(a)

the intended use of the product (or its primary function) and its mode of action;

(b)

the therapeutic claims that the manufacturer makes about the product

(claims to treat or prevent disease or to interfere with the normal operation of a physiological function of the human body);

(c)

the pharmacological active substance(s), if any, used in the product;

(d)

the concentration of the active substances;

(e)

the level of efficacy of the active substance of the product; and

(f)

the ingredients used and the concentrations at which they are used;

“Cosmetics” means any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth and includes deodorants, perfumes and cosmeceuticals;

“Cosmetics, Devices and Drugs Authority” means

Cosmetics, Devices and Drugs Authority established under the Cosmetics, Devices and

Drugs Act, No. 27 of 1980;

“counterfeit medical device” means a device which is labeled or packaged fraudulently with regard to identification;

“counterfeit medicine” means a medicine which is labeled or packaged fraudulently with regard to identification and includes any product with proper ingredients with inferior quality or containing different or inactive ingredients;

“dentist” means a person for the time being registered as a dentist under the Medical

Ordinance (Chapter 105);

“Drug Inspector” mean any person with prescribed qualifications appointed as a drug inspector by the Authority;

“exhibit” refers to a public display of medicines, medical devices or borderline products at a conference, exhibition or trade fair;

“Generic medicine” means a medicine that-

(a)

has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine;

(b)

has the same pharmaceutical form;

(c)

is bioequivalent; and

(d)

has the same safety and efficacy properties;

“Good Distribution Practice” means good distribution practice guidelines issued by the

Authority;

“Good Manufacturing Practice Guidelines” means good manufacturing guidelines issued by

World Health Organization;

“Good Pharmacy Practice” means good Pharmacy practice guidelines issued by the Authority;

“Good Storage Practice” means good storage practice guidelines issued by the Authority;

“Government Analyst” means the person for the time being holding the office of the

Government Analyst, any Additional

Government Analyst, Deputy Government

Analyst, Senior Assistant Government Analyst or Assistant Government Analyst;

“insanitary conditions” means such conditions or circumstances as are likely to contaminate medicine, medical device or borderline product with dirt or filth or render same injurious to health;

“investigational medicinal product” means a product which is under investigation by a clinical trial or equivalent studies which may include a medicine, medical device or a borderline product;

“label” includes any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled marked, embossed or impressed on, or attached to a container of medicine, medical device or borderline product;

“labeling” includes the label and any written printed or graphic matter relating to and accompanying the medicine, medical device or borderline product;

“licence” means a licence issued under this Act;

“Medical Council” means the Medical Council established under the section 12 of the Medical

Ordinance (Chapter 105);

“medical device” means any instrument, apparatus, appliance, software, material or any other article, whether used single or in combination, including the software necessary for its proper application intended by the manufacturer used in or on human beings for the purpose of:-

(a)

diagnosis, prevention, monitoring, treatment or alleviation of disease;

(b)

diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

(c)

investigation, replacement or modification of the anatomy or of a physiological process;

(d)

control of conception, and which does not achieve its intended action in or on the human body by pharmacological, immunological or metabolic means but which may be assisted in its function by such means;

a medical device does not include an Ayurveda device or a Homeopathy device;

“medical practitioner” means a person registered as a medical practitioner under section 29 or section 41 of the Medical Ordinance (Chapter 105);

“medicine” means—

(a)

any substance or mixture of substances manufactured, sold, offered for sale or represented for use in—

(i)

the diagnosis, treatment, mitigation or prevention of disease, abnormal physical states or the symptoms thereof in man or animal; and

(ii)

restoring, correcting or modifying functions of organs in man or animal;

(b)

a medicine or combination of medicine ready for use and placed on the market under a special name or in a characteristic form, both patent and non-proprietary preparations;

(c)

a product made out of medicinal herbal extract;

(d)

nutraceutical with therapeutic claims;

and

(e)

vaccines and sera, but does not include an Ayurvedic medicine or Homoeopathic medicine;

“Minister” means the Minister to whom the subject of Health is assigned and the term Ministry shall be construed accordingly;

“need” refers to circumstances in which a product is necessary because it is essential or very important rather than just desirable;

“nutraceutical” means a product isolated or purified from food which is generally sold in medicinal form not usually associated with food and provide physiological benefit or protection against chronic disease;

“package” includes anything in which any medicine, medical device or borderline product is wholly or partly contained, placed or packed;

“person” includes a company;

“Pharmacist” means a Pharmacist registered under the Medical Ordinance (Chapter105);

“prescribed” means prescribed by rules or regulations made under this Act;

“prescription” means an authorization in writing to a Pharmacist from a person authorized by law to prescribe medicines or medical devices to dispense a specified medicine or medical device for use by a designated individual or for animal use;

“prohibited medicine, medical device or borderline product” means which are prohibited by regulations made under the Act;

“secretary” means the Secretary to the Minister to whom the subject of Health is assigned;

“sell” means offer, keep or expose for sale, transmit, convey or deliver for sale, for cash or credit or by way of exchange and whether by wholesale or retail and the term “sale” shall be construed accordingly;

“smuggled medicine, medical device or borderline product” means a medicine, medical device or borderline product imported or brought in to the country in contravention of the provisions of this Act and without obtaining an import license from the Authority; and

“veterinary surgeon” means a person registered as

Veterinary Surgeon or a Veterinary Practitioner under the Veterinary Surgeons’ and

Practitioner Act, No. 46 of 1956.

Read on from s 147