In this Act, unless the context otherwise requires-
"adulterated"
means a drug, medical device, cosmetic product, public health product or nutritional supplement which-
(a)
is contaminated or unsafe for human consumption;
(b)
is manufactured, prepared, packaged, stored, transported or distributed under unsanitary conditions;
(c)
contains any harmful or unauthorised substance; or
(d)
has been substituted, diluted or otherwise treated in a manner that reduces its quality, purity, safety or efficacy, or renders it injurious to health; "adverse event" means an unintended or an unexpected medical occurrence in a patient, or a clinical trial subject, to whom a drug, cosmetic product, public health product or nutritional supplement is administered, or on whom a medical device is applied or used, which does not necessarily have a causal relationship with the treatment or clinical trial;
"adverse reaction"
means any noxious or unintended response to a drug, cosmetic product, public health product, nutritional supplement or medical device, occurring at a dose normally used in human for prophylaxis, diagnosis or therapy, including use outside the marketing authorisation, where there is a reasonable possibility of a causal relationship between the product and the response;
"advertisement"
means any pictorial, visual or other descriptive matter, verbal statement or reference-
(a)
appearing in a print or electronic publication or medium;
(b)
appearing in a broadcast on television or radio; or
(c)
brought to the notice of members of the public in any other manner, which is intended to directly or indirectly advise on the existence and benefits of a drug, medical device, cosmetic product, public health product or nutritional supplement;
"authorised pharmacopoeia"
means any pharmacopoeia recognised by the Authority, including the current edition of the international pharmacopoeia, the British pharmacopoeia, the British pharmaceutical codex, the European pharmacopoeia and the United States pharmacopoeia;
"Authority"
means the National Drug and Health Products Authority established under section
3
;
"biologicals"
means medicine containing a living organism, or which is derived from a living organism, or a biological process which is applicable to the prevention, treatment or cure of a disease or condition of a human being, and includes vaccines, blood and blood products;
"Board"
means the Board of Directors of the Authority;
"compassionate use"
means the use of an unregistered drug, medical device, cosmetic product, public health product or nutritional supplement, or a drug, medical device, cosmetic product, public health product or nutritional supplement under clinical investigation which is not a clinical trial, for the treatment of a patient suffering from a serious or life-threatening condition where no satisfactory registered prevention or treatment is available in Uganda;
"complementary medicine"
means a drug consisting wholly or principally of one or more of the following ingredients, each of which has a clearly established identity and a traditional use-
(b)
a plant or herbal material, including plant fibers, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll;
(c)
a homoeopathic preparation;
(d)
a mineral, including a mineral salt and a naturally occurring mineral;
(e)
non-human animal material, including dried material, bone and cartilage, fats and oils; or
(f)
a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis;
"cosmetic product"
means any substance or mixture intended to be placed in contact with the external parts of the human body such as the epidermis, the hair system, nails, lips or the external genital organs, or with the teeth or the mucous membranes of the oral cavity of the human body, for the exclusive or main purpose of cleaning those parts or for perfuming, changing the appearance, protecting or keeping in good condition those parts or for correcting body odours, where the cosmetic product contains-
"currency point"
has the meaning assigned to it in the Schedule;
"drug"
means any substance or mixture of substances used or intended to be used for- (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms of the disease, disorder or abnormality, in human beings;
(b)
restoring, correcting or the beneficial modification of the organic or mental functions in human beings by exerting a pharmacological, immunological or metabolic action; or (c) manufacturing as a component of any articles specified in paragraph (a) or (b), and includes biologicals, herbal medicine, complementary medicine, cosmeceuticals and nutraceuticals;
"drug shop"
means an outlet licensed under section
29
;
"emergency situation"
means a circumstance which is urgent or unforeseeable, or a situation which is not caused by dilatory conduct where-
(a)
there is serious threat or actual confrontation with disaster, catastrophe, war or an act of God; or
(b)
life or the quality of life or environment may be seriously compromised; "extraordinary circumstance" includes a pandemic, emergencies including an epidemic, shortage of pharmaceuticals, economic embargo on importation of pharmaceuticals and such other similar circumstances; "falsified" means a drug, medical device, cosmetic product, public health product or nutritional supplement which deliberately misrepresents the identity, composition or source of the drug, medical device, cosmetic product, public health product or nutritional supplement;
"health professional"
means a person who is regulated under the Medical and Dental Practitioners Act, the Pharmacy and Drugs Act, the Nurses and Midwives Act, the Allied Health Professionals Act or any other recognised professional regulatory body; "herbal medicine" means any medicine that exclusively contains as active ingredients, one or more parts of natural organic or inorganic plant materials with or without animal or mineral materials in a form suitable for administration to human beings;
"inspection of premises"
includes inspection of the land, courtyard and any other area to be used, or used in connection to the area to be used or used for the business activity for which a licence or certificate is required under this Act;
"lot release"
means the process of evaluating each individual lot of vaccines, biologicals, diagnostics and other medicinal products before giving approval for their release to the market;
"manufacture or manufacturing"
includes all operations of production, processing, receiving of materials, packaging, repackaging, labelling, relabelling, quality control, release or storage and related controls of drugs, medical devices, cosmetic products, public health products or nutritional supplements;
"medical device"
means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article including any component, part or accessory of it-
(a)
used in human beings for- (i) the diagnosis, prevention, monitoring, treatment or alleviation of a disease, a disorder or an abnormal physical state or an injury or a symptom of any of these, as the case may be;
(ii)
supporting and sustaining life;
(iii)
the diagnosis, monitoring, treatment or alleviation of, or compensation of an injury;
(iv)
the diagnosis of a pregnancy;
(v)
the control of conception;
(vi)
investigation, replacement, modification or support of the anatomy or of a physiological process; or
(vii)
providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;
(b)
used for the disinfection, cleaning or sterilisation of a medical device, which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means but which may be assisted in its intended action by such means;
"Minister"
means the Minister responsible for health;
"Ministry"
means the Ministry responsible for health;
"nutritional supplement"
means any product or substance which supplements the normal diet and which is a concentrated source of a vitamin or mineral, or other substance with a nutritional or physiological effect, alone or in combination;
"pharmacist"
means a person registered as such under the Pharmacy and Drugs Act;
"proprietary name"
means the name of a drug under which the drug is distributed;
"public health product"
means an item, instrument, apparatus, implement, machine, appliance, calibrator, software, material or other similar or related article, substance or mixture of substances intended for industrial or public health use, for the prevention of disease or promotion of health among the population;
"substandard "
means a drug, medical device, cosmetic product, public health product or nutritional supplement which is not of the nature, substance, quality or specification prescribed under this Act;
"supply"
with its grammatical variations and cognate expressions means, in relation to a product regulated under this Act, the administration or application of the product and includes the sale of the product;
"vessel"
includes a ship, boat, aircraft or carriage of receptacle of any kind whether open or closed.
