Public Health Act 851 Interpretations

Question 1

Article

Answer 1

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 2

Authorised officer

Answer 2

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 3

Codex

Answer 3

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

Question 4

Container

Answer 4

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

Question 5

Cosmetic

Answer 5

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

Question 6

Court

Answer 6

A court of competent jurisdiction.

Question 7

Drugs

Answer 7

• 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 8

Device

Answer 8

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

Question 9

Export

Answer 9

Taking out of the Republic.

Question 10

Food

Answer 10

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

Question 11

Health inspector

Answer 11

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

Question 12

Herbal medicinal product

Answer 12

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

Question 13

Homeopathy

Answer 13

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

Question 14

Household chemical substance

Answer 14

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

Question 15

Industrial purposes

Answer 15

Use other than for human or animal consumption.

Question 16

Insanitary conditions

Answer 16

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

Question 17

Manufacture

Answer 17

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

Question 18

Definition of ‘manufacture’

Answer 18

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 19

Medical device

Answer 19

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.

Question 20

Definition of ‘Minister’

Answer 20

means the Minister responsible for Health.

Example: The Minister announced new healthcare policies.

Question 21

Definition of ‘naturopathy’

Answer 21

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 22

Definition of ‘package’

Answer 22

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 23

Definition of ‘person’

Answer 23

includes a media house for purposes of advertisements.

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

Question 24

Definition of ‘premises’

Answer 24

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 25

Definition of ‘products regulated under this Part’

Answer 25

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 26

Definition of ‘public analyst’

Answer 26

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 27

Definition of ‘Regulations’

Answer 27

means the Regulations made under this Part.

Example: The Regulations outline the guidelines for product labeling.

Question 28

Definition of ‘slaughter facility’

Answer 28

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 29

Definition of ‘substance’

Answer 29

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 30

Definition of ‘unfit product’

Answer 30

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

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

Question 31

Parallel importation

Answer 31

Importing a drug without authorisation of the drug registration holder from another country where it is legitimately placed.