- Section 62 of Health Act No 21 of 2017: Establishment of a single regulatory body for health products and technologies
There shall be established by an Act of Parliament, a single regulatory body for regulation of health products and health technologies.
- Section 63 of Health Act No 21 of 2017: Functions of the regulatory body
(1) The regulatory body shall—
(a) licence health products and health technologies;
(b) licence manufacturers and distributors of health products;
(c) conduct laboratory testing and inspection of manufacturing, storage and distribution facilities of health products and technologies;
(d) control...
- Section 64 of Health Act No 21 of 2017: Conditions
Legislation under section 62 shall provide for the granting of marketing approval only by a technically competent body after appropriate assessment has established that such a product meets generally recognized standards and approval may be made subject to conditions, notably with respect to the...
- Section 65 of Health Act No 21 of 2017: Licences
(1) No person, firm or institution may engage in one or more of the activitiesspecified in section 63(1) whether by way of trade or otherwise, unless one has a valid licence granted by the single regulatory body established under this Part.
(2) Any person, firm or institution in the possession of...
- Section 66 of Health Act No 21 of 2017: Standards
Any medicine, vaccine or other health product and technology intended for sale to members of the public shall be eligible for licensing only if—
(a) after due assessment, it is found to achieve the therapeutic or the intended effect it claims to possess or which may reasonably be attributed to...
- Section 67 of Health Act No 21 of 2017: Procurement of health products and technologies
(1) The procurement for the public health services of health products and technologies shall be undertaken in line with the Public Procurement and Disposal Act as well as the inter-governmental arrangements for medicine and medical products agreed upon.
(2) The classes of products procured by Kenya...
- Section 68 of Health Act No 21 of 2017: Public and environmental health
(1) The National health system shall devise and implement measures to promote health and to counter influences having an adverse effect on the health of the people including—
(a) interventions to reduce the burden imposed by communicable and non-communicable diseases and neglected diseases,...
- Section 69 of Health Act No 21 of 2017: Policies
Pursuant to meeting the objects set out in section 68, the national government department of health shall formulate national strategic and operation policies that shall provide for measures that include—
(a) ensuring and promoting the provision of quarantine especially in ports, borders and...
- Section 70 of Health Act No 21 of 2017: Amendment of Cap. 242
The Public Health Act (Cap. 242) is amended by deleting the expression "Director of Medical Services" and substituting therefor the expression "Director General for health", wherever it appears.
- Section 71 of Health Act No 21 of 2017: Lactation stations in the workplace
(1) All employers shall in the workplace establish lactation stations which shall be adequately provided with necessary equipment and facilities including hand washing equipment, refrigerates or appropriate cooling facilities, electrical outlets for breast pumps, a small table comfortable seats the...
- Section 72 of Health Act No 21 of 2017: Provision of break intervals for nursing employees
(1) An employer shall grant all nursing employees break intervals in addition to the regular times off for meals to breast feed or express milk.
(2) The time intervals referred to in subsection (1) shall include the time it takes an employee to get to and from the lactation station and shall be...
- Section 73 of Health Act No 21 of 2017: Mental health
There shall be established by an Act of Parliament, legislation to—
(a) protect the rights of any individual suffering from any mental disorder or condition;
(b) ensure the custody of such persons and the management of their estates as necessary;
(c) establish, manage and control mental hospitals...
- Section 74 of Health Act No 21 of 2017: Promotion of practice
(1) The national government department of health shall formulate policies to guide the practice of traditional and alternative medicine.
(2) The county executive department for health shall ensure implementation of any policies thereto.
- Section 75 of Health Act No 21 of 2017: Regulation of practice on traditional medicine
(1) There shall be established regulatory body by an Act of Parliament, to regulate the practice of traditional medicine and alternative medicine.
(2) The regulatory body shall, maintain a register at both the national and county levels.
(3) The regulatory body in consultation with the National...
- Section 76 of Health Act No 21 of 2017: Documentation and mapping
The regulatory body shall institute measures for documentation and mapping of traditional and alternative medicine practice and the county executive departments for health shall facilitate the mapping of traditional and alternative medicine.
- Section 77 of Health Act No 21 of 2017: Standardization
The national government department for health shall, in consultation with key stakeholders develop policies for standardization of traditional and alternative medicine practice.
- Section 78 of Health Act No 21 of 2017: Charges
The charges levied on the practice of traditional medicine shall be approved by the Authority in consultation with statutory bodies.
- Section 79 of Health Act No 21 of 2017: Referral
The national government department of health shall develop policy guidelines for referral mechanisms and a system of referrals from practitioners of traditional and alternative medicine to conventional health facilities and may prescribe regulations for incidental and connected purposes which shall...
- Section 80 of Health Act No 21 of 2017: Human organs transplantation
(1) No person shall remove tissue or gametes from a human being for transplantation in another human being or carry out the transplantation of such tissue or gametes except—
(a) in a duly authorized health facility for that purpose; and (b) on the written authority of—
(i) the medical practitioner...
- Section 81 of Health Act No 21 of 2017: Making of wills
(1) (a) A person who is competent to make a will may—
in the will; or
in a document signed by him or her in the presence of at least two competent witnesses who are present when he or she signs and signed by them in his or her presence; or
in an oral statement made in the presence of at least two...
- Section 82 of Health Act No 21 of 2017: Donation purposes
(1) A donation under section 83 may only be made for—
(a) the purposes of the training of students in health sciences;
(b) the purposes of health research;
(c) the purposes of the advancement of health sciences;
(d) therapeutic purposes, including the use of tissue in any living person;...
- Section 83 of Health Act No 21 of 2017: Revocation
A donor may, prior to the transplantation of the relevant organ into the donee, revoke a donation in the same way in which it was made or, in the case of a donation by way of a will or other document, also by the intentional destruction of that will or document.
- Section 84 of Health Act No 21 of 2017: Postmortem
(1) Subject to subsection (2), a post mortem examination of the body of a deceased person may be conducted if—
(a) the person when alive gave consent thereto;
(b) the spouse(s), child, guardian, brother or sister of the deceased, in the specific order mentioned, gave consent thereto; or such an...
- Section 85 of Health Act No 21 of 2017: Kenya National Blood Transfusion Service
(1) There shall be established by an Act of Parliament, a body to be known as the Kenya National Blood Transfusion Service.
(2) The legislation contemplated under subsection (1) shall provide for among other things, the institutional organization of blood transfusion service within the Republic of...
- Section 86 of Health Act No 21 of 2017: Health finance
(1) The department of health shall ensure progressive financial access to universal health coverage by taking measures that include—
(a) developing mechanisms for an integrated national health insurance system including making provisions for social health protection and health technology...
- Section 87 of Health Act No 21 of 2017: Bank account
(1) The National Treasury shall, facilitate the opening and maintenance of bank accounts by the county treasuries, for purposes of operationalizing disbursements of conditional grants, donation and any other monies designated for health as may be prescribed, in accordance with the provisions of the...
- Section 88 of Health Act No 21 of 2017: Private health services
(1) The Cabinet Secretary shall pursue strategies conducive to the development and regulation of private health services and their atonement to the needs of the population.
(2) The public and private health services and facilities shall complement each other in the provision of comprehensive and...
- Section 89 of Health Act No 21 of 2017: Licensing of private entities to operate hospitals. clinics, etc.
(1) Private entities shall be permitted to operate hospitals, clinics, laboratories and other institutions in the health sector, subject to licensing by the appropriate regulatory bodies.
(2) The standards to be met in order to qualify for the issue of an operational licence under this section and...
- Section 90 of Health Act No 21 of 2017: Private health workers
Private health workers appropriately qualified to practice any health profession shall similarly be entitled to practice their profession in Kenya, subject to licensing by the appropriate regulatory bodies.
- Section 91 of Health Act No 21 of 2017: Duty of licensees
(1) Institutions licensed under section 88 and private health workers licensed under section 89 shall irrespective of any specific conditions attached to such a licence be bound—
(a) to permit and facilitate inspection at any time by the Authority and regulatory bodies;
(b) to provide emergency...