Public Health Act 851 Interpretations

Question 1

Authority

Answer 1

The Food and Drugs Authority established under section 80.

Example: The Authority is responsible for regulating food and drugs in the country.

Question 2

Advertisement

Answer 2

A representation for the purpose of promoting the sale or disposal of a regulated product.

Example: TV commercials are a common form of advertisement.

Question 3

Article

Answer 3

Includes products regulated under this Part, things used for manufacturing regulated products, and labeling or advertising materials for food, drugs, herbal medicine, cosmetics, medical devices, or household chemical substances.

Question 4

Authorised officer

Answer 4

A person authorized to perform functions under this Part by the Chief Executive Officer, the Minister, a District Assembly, or the Authority.

Example: Health inspectors are often authorized officers.

Question 5

Board

Answer 5

The governing body of the Authority.

Question 6

Certificate

Answer 6

A document issued by the Authority under this Part.

Question 7

Codex

Answer 7

Standards, codes of practice, guidelines, and recommendations issued by the Codex Alimenterius Commission.

Question 8

Container

Answer 8

Includes receptacles such as bottles, jars, boxes, packets, sachets, etc., for regulated products.

Question 9

Cosmetic

Answer 9

Substances or mixtures for cleansing, improving, or altering complexion, skin, hair, etc., and deodorants and perfumes.

Question 10

Court

Answer 10

A court of competent jurisdiction.

Question 11

Drugs

Answer 11

• a substance referred to in a publication mentioned in the 4th Schedule,
• a substance or mixture of substances prepared, sold or represented for use in
  (i) the diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal physical state or the symptoms of it, in man or animal, or
  (ii) restoring, correcting or modifying organic functions in man or animal, and
• nutritional supplements

Question 12

Device

Answer 12

An instrument or apparatus for diagnosing, treating, mitigating, or preventing diseases or disorders in humans or animals.

Question 13

Export

Answer 13

Taking out of the Republic.

Question 14

Food

Answer 14

Includes water, food products, live animals, live plants, substances for human or animal consumption, ingredients, additives, chewing gum, etc.

Question 15

Health inspector

Answer 15

A person appointed to be a health inspector or a sanitary inspector.

Question 16

Herbal medicinal product

Answer 16

Plant-derived material preparations with therapeutic benefits containing ingredients from plants or organic/animal origin.

Question 17

Homeopathic

Answer 17

Substances that can be attenuated to render them stronger, or substances that can cause symptoms and relieve them in others.

Question 18

Homeopathy

Answer 18

An alternative medicine system based on treating patients with minute quantities of substances that produce symptoms of the disease.

Question 19

Household chemical substance

Answer 19

Substances for domestic or office use as germicides, antiseptics, disinfectants, pesticides, etc.

Question 20

Import

Answer 20

Bringing into the Republic.

Question 21

Industrial purposes

Answer 21

Use other than for human or animal consumption.

Question 22

Insanitary conditions

Answer 22

Conditions that might contaminate regulated products with dirt or filth or render them injurious to health.

Question 23

Label

Answer 23

Includes legends, tags, brands, marks, etc., attached to regulated products.

Question 24

Manufacture

Answer 24

Operations involved in the production, preparation, processing, packaging, labeling, etc., of regulated products.

Question 25

Definition of ‘label’

Answer 25

includes a legend, tag, brand, work or mark, pictorial or any other descriptive matter written, printed, stenciled, marked, embossed or impressed on or attached to a product regulated under this Part.

Example: The label on the medicine bottle contains important dosage information.

Question 26

Definition of ‘manufacture’

Answer 26

includes the operations involved in the production, preparation, processing, compounding, formulating, filling, refining transformation, packing, packaging, re-packaging, and labeling of products regulated under this Part.

Example: The manufacture of the food product involves various steps from processing to packaging.

Question 27

Definition of ‘medical device’

Answer 27

means an instrument, apparatus, implement, medical equipment, machine, contrivance, implant, in vitro reagent or any other similar or related article, including a component, part or an accessory which is recognized in the official natural formulary or pharmacopoeia or a supplement to them, intended for use in the diagnosis of a disease or any other condition, or in the cure, mitigation, treatment or prevention of disease in humans and animals, or intended to affect the structure or function of the body of the human being or other animal and which does not achieve any of its principal intended purposes through chemical action within the body of the human being or any other animal and which is not dependent on being metabolized for the achievement of any of its principal intended purposes.

Example: The medical device is used for monitoring blood glucose levels in diabetic patients.

Question 28

Definition of ‘Minister’

Answer 28

means the Minister responsible for Health.

Example: The Minister announced new healthcare policies.

Question 29

Definition of ‘naturopathy’

Answer 29

means a system of the treatment of a disease by seeking to assist natural recovery.

Example: The naturopathy clinic focuses on holistic healing methods.

Question 30

Definition of ‘package’

Answer 30

means in relation to a product regulated under this Part, a box, packet or any other article in which one or more primary containers of products regulated under this Part is or are to be enclosed in one or more other boxes, packets or articles in question, the collective number of them.

Example: The package contains multiple smaller boxes of the product.

Question 31

Definition of ‘person’

Answer 31

includes a media house for purposes of advertisements.

Example: The person responsible for the advertisement campaign is from a media house.

Question 32

Definition of ‘premises’

Answer 32

includes land, buildings, structures, basements, and vessels and in relation to a building, includes a part of a building and the cartilage, forecourt, yard or place of storage used in connection with the building or part of the building and in relation to a vessel, includes a ship, boat, an aircraft, a carriage or receptacle of any kind whether open or closed.

Example: The premises of the factory were inspected for compliance with safety regulations.

Question 33

Definition of ‘products regulated under this Part’

Answer 33

means food, drugs, cosmetics, household chemical substances, food supplements, tobacco, herbal medicines, and medical devices.

Example: The agency oversees the quality control of products regulated under this Part.

Question 34

Definition of ‘public analyst’

Answer 34

means a person appointed by the Minister to act as an analyst for the purposes of this Part.

Example: The public analyst conducted tests to determine the purity of the samples.

Question 35

Definition of ‘Regulations’

Answer 35

means the Regulations made under this Part.

Example: The Regulations outline the guidelines for product labeling.

Question 36

Definition of ‘sell’ or ‘sale’

Answer 36

includes sell or sale by wholesale or retail, import, offer, advertise, keep, expose, display, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale, or prepare or possess for sale and barter or exchange, supply or dispose of to a person whether for a consideration or otherwise.

Example: The company sells its products through various channels including online and offline stores.

Question 37

Definition of ‘selling’

Answer 37

includes offering for sale, exposing for sale and having in possession for sale or distribution.

Example: The selling of counterfeit goods is illegal.

Question 38

Definition of ‘slaughter facility’

Answer 38

means a slaughterhouse, slaughter slab, abattoir and premises or a place habitually used for the slaughter of animals for human or animal consumption.

Example: The slaughter facility was inspected for compliance with animal welfare standards.

Question 39

Definition of ‘substance’

Answer 39

means a natural or artificial substance whether in solid or liquid form or in the form of a gas, vapor or radiation.

Example: The substance used in the experiment was carefully measured for accuracy.

Question 40

Definition of ‘unfit product’

Answer 40

means a product regulated under this Part which contravenes a provision of this Part.

Example: The authorities issued a recall for the unfit product.