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"id": 1494122,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494122/?format=api",
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"type": "speech",
"speaker_name": "Hon. Omboko Milemba",
"speaker_title": "The Temporary Chairman",
"speaker": {
"id": 13328,
"legal_name": "Jeremiah Omboko Milemba",
"slug": "jeremiah-omboko-milemba"
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"content": "Hon. Members, we were able to achieve this because of the winnowing process that was ordered by the Speaker. There were many proposed amendments to this clause by Hon. Oluoch, Hon. Kaluma and Hon. Millie, who was here in the morning. She is back in the House. Proceed to move all the amendments, Hon. Chairman."
},
{
"id": 1494123,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494123/?format=api",
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"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
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"content": " Hon. Temporary Chairman, I beg to move: THAT, Clause 2 of the Bill be amended— (a) in the definition of “article” by– (i) inserting the words “dietary supplement” immediately after the words “therapeutic cosmetic” appearing in paragraph (a); and, (ii) inserting the words “dietary supplement” immediately after the words “therapeutic cosmetic” appearing in paragraph (b); (b) in the definition of “Authority” by deleting the words “Kenya Drugs Authority” and substituting therefor the words, “Kenya Health Products and Technologies Regulatory Authority”; (c) in the definition of “chemical substance” by deleting the words “or detergent”; (d) in the definition of “drug” by deleting the word “if” appearing in paragraph (b)(ii) and substituting therefor the word “of”; (e) by deleting the definition of “enrolled pharmaceutical technologist”; (f) in the definition of “health products and technologies” by inserting the words, “dietary supplements” immediately after the words, “therapeutic cosmetics”; (g) by deleting the definition of “herbal medicine or product”; (h) by deleting the definition of “medical device”; (i) by deleting the definition of “medicinal substance”; (j) in the definition of “package” by inserting the words “dietary supplement” immediately after the words “therapeutic cosmetic”; (k) by deleting the definition of “pharmacy”; (l) by deleting the definition of “pharmaceutical technologist”; (m) by deleting the definition of “registered midwife”; (n) in the definition of “scheduled substance” by deleting the phrase “in the relevant schedule under this Act” and substituting therefor the phrase “in the list published by the Cabinet Secretary under section 37”; (o) by deleting the definition of “therapeutic cosmetic”; and, (p) by inserting the following new definitions in their proper alphabetical sequence— “active surveillance” means prospective measures taken to detect adverse drug reactions and adverse events and involves active follow-up during and after treatment of patients where the The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
},
{
"id": 1494124,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494124/?format=api",
"text_counter": 561,
"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": "events may be detected by asking the patient directly or screening patient records; “adverse drug reaction” means a response to a drug which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function and is characterized by the suspicion of a causal relationship between a medical product and an occurrence; “adverse event” means any untoward medical occurrence that may present during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with the treatment; “alternative medicine” means complementary medicine and includes a broad set of health care practices that are not part of Kenya’s tradition and are not integrated into dominant health care system; “biologicals” means a diverse group of medicines which includes vaccines, growth factors, immune modulators, monoclonal antibodies and includes products derived from human blood and plasma; “Board” means the Board of the Authority established under section 8; “Centre” means the National Pharmacovigilance Centre established under section 59B; “clinical trial” means any systematic study on pharmaceutical products in human subjects, whether in patients or other volunteers, in order to discover or verify the effects of, identify any adverse reaction to investigational products, study the absorption, distribution, metabolism and excretion of the products with the object of ascertaining their efficacy and safety; “dietary supplement” means a product taken by mouth that is added to the diet to help meet daily requirements of essential nutrients, and which usually contains one or more dietary ingredient and includes vitamins, minerals and herbs; “enrolled pharmaceutical technologist” means a person enrolled as such by the body for the time being responsible for the enrolment of pharmaceutical technologists; “falsified medical product” means a product that is deliberately or fraudulently misrepresented in relation to its identity, composition or source; “Field Safety Corrective Action” means any action taken by a product owner to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device, and includes— (a) the return of a medical device to the product owner or its representative; (b) device modification which may include— (i) retrofit in accordance with the product owner’s modification or design change; The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
},
{
"id": 1494125,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494125/?format=api",
"text_counter": 562,
"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": "(ii) permanent or temporary changes to the labelling or instructions for use; (iii) software upgrades including those carried out by remote access; (iv) modification to the clinical management of patients to address a risk of serious injury or death related specifically to the characteristics of the device; (v) device exchange; (vi) device destruction; or, (vii) advice given by product owner regarding the use of the device. “health product” includes a medicine, medical product, medicinal substance, vaccine, diagnostic, medical device, blood or blood product, herbal medicine, therapeutic feed and nutritional formulation, cosmetic and related products; “health technology” means the application of organised knowledge and skills in the form of medicines, devices, vaccines, procedures, and systems developed to solve a health problem and improve the quality of lives, and includes radiation-emitting devices and related products; “herbal medicine or product” means a plant derived material or preparations with claimed therapeutic or other health benefits, which contain either raw or processed ingredients from one or more plants or material of inorganic or animal origin and includes herbs, herbal materials, herbal preparations, finished herbal products that contain active ingredients, parts of plants or other plant materials or combinations; “Inspector of Drugs” means a person who is competitively recruited by the Authority as a drug inspector under this Act; “lot” or “sub-lot” means a defined quantity of starting material, packaging material or product, processed in a single process or series of processes so that the quantity is expected to be homogeneous; and in the case of continuous manufacture, the lot corresponds to a defined fraction of the production characterized by its intended homogeneity; “lot release” means the process of the evaluation of an individual lot of a licensed biological product by the Authority before giving approval for its release onto the market; “marketing authorisation” means the certificate of registration issued by the competent health product regulatory authority in the country of origin for the purpose of marketing or free distribution of a health product after evaluation for safety, efficacy and quality; “medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purposes of— (a) diagnosis, prevention, monitoring, treatment or alleviation of disease; The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
},
{
"id": 1494126,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494126/?format=api",
"text_counter": 563,
"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": "(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (c) investigation, replacement, modification or support of the anatomy or of a physiological process; (d) supporting or sustaining life; (e) control of conception; (f) disinfection of medical devices; (g) providing information by means of in vitro examination of specimens derived from the human body; (h) disinfection substances; (i) aids for persons with disabilities; (j) devices incorporating animal or human tissues; (k) devices for in-vitro fertilization or assisted reproduction technologies, and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means; “medicinal substance” means a substance, the origin of which may be human, animal, vegetable or chemical, including human blood and human blood products, micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products, micro-organisms, plants, parts of plants, vegetable secretions, extracts, elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis; “passive surveillance” means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns; “parallel importation” means importation into Kenya, by a licensed importer of a health product, other than the marketing authorization holder or his or her technical representative, of the following health products which require marketing authorization in Kenya— (a) patented health products under the applicable law; (b) non-patented health products; or, (c) branded generic health products; “parallel imported medicinal substance” means a medicinal substance imported into Kenya under this Act; “pharmacovigilance” means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible health product related problem; “premise” includes any land, building, dwelling-place or any other place whatsoever; and includes stand-alone community retail pharmacy, private hospital pharmacy, The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
},
{
"id": 1494127,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494127/?format=api",
"text_counter": 564,
"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": "public health facility pharmacy, wholesale pharmacy or distribution outlet, where health products and technologies are stored, handled or distributed; “Registrar” means the Director-General of the Authority appointed under section 6; “scheduling” means, in relation to a substance, the determination of the schedule or schedules to the current poisons standard in which the name or a description of the substance is to be included; “therapeutic cosmetic” means a product with the ability to trigger biological actions on the dermis, skin, eyes or teeth, to prevent future damage and contains ingredients that are usually not found in regular cosmetics or at higher strengths than could be sold safely over the counter; “traditional medicine” includes the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness; “unregistered medical product” means a product that has not undergone evaluation and approval by the Authority subject to permitted conditions under the Act and the rules therein; “vessel” means a truck, van, bus, minibus, car, trailer, aircraft, railway carriage, boat and other means that are used for purposes of conveying health products and technologies; “wholesale dealer” means a person who is licensed to carry out a business where health products and technologies are stored, distributed or sold in bulk to persons other than individual consumers and includes registration, importation, warehousing, good distribution practices and pharmacovigilance;”. In (a) under (1) and (2), this is for inclusion of dietary supplements which are part of health products and technologies, while ((b) is to ensure harmony with the Title of the Bill as proposed for amendment. Part (c), is to exclude detergents which are used for cleaning inanimate objects and does not fall under the purview of the regulation of health products and technologies. The amendment in (d), is to correct a minor typographical error whereas that in (e) is the current definition cross-references the Farmers and Poisoners Act, Cap244, which will be repealed as provided under Clause 97, and a new definition proposed. The amendment in (f) is for inclusion of dietary supplements which are part of health products and technologies, while (g), (h) and (l), are new definitions that are provided for those terms. These new definitions expand the scope to cover all aspects of the use of medical devices and medicinal substances in relation to health and to include herbal materials and herbal combinations. Part (j) is for inclusion of dietary supplements which are part of health products and technologies. With regard to the amendment under (k), the current definition is inadequate The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
},
{
"id": 1494128,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494128/?format=api",
"text_counter": 565,
"type": "speech",
"speaker_name": "Endebess, UDA",
"speaker_title": "Hon. (Dr) Robert Pukose",
"speaker": null,
"content": "and, therefore, the term is to be defined in the proposed Pharmaceutical Practise Bill. In (l), the Farmers and Poisoners Act, Cap 244, provided that a pharmaceutical technologist must be enrolled in the role established under this Act. With regard to the amendment under (m), the term is no longer used in the Bill in line with the proposed amendment of Clause 43(1)(c). In (n), there is no schedule on scheduled substances. The cabinet secretary will publish the list of scheduled substances in the gazette. Under (o), the current definition defines cosmetics in general that are meant to provide the body with the appropriate aesthetics, texture, pH, colour and smell. It is not specific to special cosmetics. In Clause 2(p) of the Bill, we are giving various new definitions which are internationally recognised by the World Health Organisation (WHO). They are critical for the execution of regulatory functions of the Authority, to further identify the Board as used in the Bill, and to provide new definitions for the world's enrolled pharmaceuticals technologists, therapeutic cosmetics, herbal medicine, medical devices and medical substances. The amendment also introduces the definition of the registrar to mean the Director-General of the Authority, as the term is used in various clauses in the Bill. Thank you, Hon. Temporary Chairman."
},
{
"id": 1494129,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494129/?format=api",
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"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "(Question of the amendment proposed)"
},
{
"id": 1494130,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494130/?format=api",
"text_counter": 567,
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"speaker": null,
"content": "(Question, that the words to be inserted be inserted, put and agreed)"
},
{
"id": 1494131,
"url": "http://info.mzalendo.com/api/v0.1/hansard/entries/1494131/?format=api",
"text_counter": 568,
"type": "scene",
"speaker_name": "",
"speaker_title": "",
"speaker": null,
"content": "(Question, that the words to be left out be left out, put and agreed to)"
}
]
}