The Nurses (Nursing Commodities) Regulations, 2012

Legal Notice 17 of 2013

This is the version of this Legal Notice as it was from 22 February 2013 to 30 December 2022. Read the latest available version.
The Nurses (Nursing Commodities) Regulations, 2012
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LAWS OF KENYA

NURSES AND MIDWIVES ACT

THE NURSES (NURSING COMMODITIES) REGULATIONS, 2012

LEGAL NOTICE 17 OF 2013

  • Published in Kenya Gazette Vol. CXV—No. 28 on 22 February 2013
  • Commenced on 22 February 2013

Part I – PRELIMINARY

1. Citation

These Regulations may be cited as the Nurses (Nursing Commodities) Regulations, 2012.

2. Interpretation

In these Regulations, unless the context otherwise requires—“authorized officer” means an officer appointed under regulation 6;“Council” has the meaning assigned to it by the Act;“Kenya Standard” has the meaning assigned to it by section 2 of the Standards Act (Cap. 496);“licence” means a licence issued under regulation 3;“nursing commodity” means a commodity used by a nurse in the practice of nursing and includes any of the commodities specified in the First Schedule.

Part II – APPROVAL OF NURSING COMMODITIES

3. Approval by Council

(1)Subject to such exemptions as may be specified by the Council, no person shall—
(a)manufacture or otherwise produce;
(b)sell or dispose of;
(c)import or cause to be imported; or
(d)export or cause to be exported, any nursing commodity unless the commodity conforms to the relevant Kenya Standard and the person has obtained the prior approval of the Council signified by the grant of a licence as set out in these Regulations.
(2)For the purposes of paragraph (1), a nursing commodity shall be deemed to have been exported when it is placed on a ship, aircraft, train or any other vehicle within Kenya for the purposes of export.

4. Application and issuance of a licence

(1)A person who manufactures, sells, imports or exports any nursing commodity shall apply, to the Council for an appropriate licence or for a renewal of the licence.
(2)The application for a licence under paragraph (1) shall be in Form A set out in the Second Schedule and shall be accompanied with—
(a)the relevant permit from Kenya Bureau of Standards evidencing compliance with the Kenya Standard;
(b)certified copies of the certificate of registration or incorporation where the applicant is a firm or company together with a certified list of the partners or directors;
(c)such fees as the Council may specify;
(d)such other documentation as the Council may require.
(3)On receiving an application for a licence or for a renewal of a licence the Council may, issue to the applicant the appropriate licence or renew the licence.
(4)If the Council refuses to issue a nursing commodity licence, the Council shall notify the applicant in writing of the reasons for the refusal and give the applicant an opportunity to be heard.
(5)A licence issued under this Regulation shall—
(a)be in Form B set out in the Second Schedule;
(b)authorize the licensee to manufacture, sell, import or export any nursing commodity;
(c)be specific with regard to the nursing commodity and person to whom it is issued;
(d)be valid for a period of one year or such other period as the Council may determine at the time of granting or renewal;
(e)contain such other conditions as the Council deems necessary to impose.
(6)A licence issued under this regulation may—
(a)be amended at any time on written notice to the holder by the Council, if in its opinion, the amendment is necessary for the purposes of public safety;
(b)be suspended or revoked by the Council if the holder fails to comply with the conditions contained in the licence or laid down in these Regulations.
(7)The Council may suspend a nursing commodity licence if the Council has reasonable grounds to believe that—
(a)the licensee has contravened these Regulations or any provision of the Standards Act;
(b)the licensee has made a false or misleading statement in the application;
(c)the licensee has failed to comply with the terms and conditions of the licence;
(d)the licensee has not complied with a request for information or samples made by the day specified in the request, or the information or samples provided are insufficient to enable the Council to determine whether the nursing commodity meets the safety and effectiveness requirements;
(e)the nursing commodity no longer meets the safety and effectiveness requirements; or
(f)on the basis of information obtained after the commodity was licensed, the quality management system under which the commodity has been designed, or manufactured, assembled, processed, packaged, refurbished or modified, is inadequate to ensure that the commodity meets its specifications.
(8)The Council shall not suspend a nursing commodity license until—
(a)the Council has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;
(b)if corrective action is required, the time set out in the notice has passed without the action having been taken; and
(c)the licensee has been given an opportunity to be heard in respect of the suspension.

5. Complaints on nursing commodities

(1)Any person may lodge a complaint to the Council in respect of a nursing commodity.
(2)A complaint under paragraph (1) shall be lodged in Form C set out in the Second Schedule and shall be accompanied by any supporting documentation as may be necessary.
(3)Upon receipt of a complaint under paragraph (1), the Council shall investigate the complaint and take any action as authorised in this regulation in relation to the licence granted to the person complained against.
(4)The licensee shall be given an opportunity to be heard during the investigations under this regulation.

Part III – INSPECTIONS

6. Authorised officers

(1)The Minister shall, upon recommendation by Council, appoint for each county, any person or class of persons to be authorised officers for purposes of these Regulations.
(2)The Minister shall issue a certificate of appointment to every person appointed under this regulation.
(3)Notwithstanding the provisions of this regulation, any person upon whom this law vests functions of maintenance of law and order, shall be deemed to be authorised officers for the purposes of these Regulations.

7. Places authorized officers may enter

(1)For the purposes of ensuring compliance with these Regulations, an authorised officer may, at any reasonable time, enter any place in which the officer believes on reasonable grounds that any person or persons is in any way contravening the provisions of these Regulations.
(2)An authorised officer entering any premises under this regulation shall, if so required, produce for inspection by the person who is or appears to be in charge of the premises the certificate issued to him under regulation 6(2).

8. Powers of officers

In carrying out an inspection in any place pursuant to regulation 7, an authorised officer may—
(a)examine any nursing commodity or anything referred to in that regulation;
(b)require any person in such place to produce for inspection, in the manner and form requested by the officer, the nursing commodity or thing;
(c)open or require any person in the place to open any container or package found in the place that the officer believes on reasonable grounds contains the nursing commodity or thing;
(d)conduct any test or analysis or take any measurements; or
(e)require any person found in the place to produce for inspection or copying, any written or electronic information that is relevant to the administration or enforcement of these Regulations.

9. Use of records

In carrying out an inspection in a place, an authorised officer may—
(a)use or cause to be used any computer system in the place to examine data contained in or available to the computer system that is relevant to the administration or enforcement of these Regulations;
(b)reproduce the data in the form of a print-out or other intelligible output and take it for examination or copying;
(c)use or cause to be used any copying equipment in the place to make copies of any data, record or document;
(d)scrutinize any other record system in use in that place.

10. Entry of dwelling place

An authorised officer may not enter a dwelling place except with the consent of the occupant or under the authority of a warrant issued under regulation 11.

11. Court to issue warrant

(1)Upon an ex-parte application, a magistrate or judge of the High Court, may issue a warrant authorising the authorised officer named in the warrant to enter and inspect a dwelling place, subject to any conditions specified in the warrant, if the magistrate or judge is satisfied by information on oath that—
(a)the dwelling place is a place referred to in regulation 10;
(b)entry to the dwelling place is necessary for the administration or enforcement of these Regulations;
(c)the occupant does not consent to the entry, or that entry has been refused or there are reasonable grounds for believing that it will be refused.
(2)The time of such entry shall be between six o’clock in the forenoon and six o’clock in the afternoon of any day of the week.

12. Use of force

An authorised officer executing the warrant issued under regulation 11 shall not use force unless such officer is accompanied by a police officer and the use of force is specifically authorised in the warrant.

13. Certificate of analysis

An authorised officer who has analyzed or examined any nursing commodity or thing under these Regulations, or a sample of it, shall issue a certificate or report setting out the results of the analysis or examination.

14. Assistance of officers

(1)The owner of a place inspected by an authorised officer under these Regulations or the person in charge of the place and every person found in the place shall—
(a)provide all reasonable assistance to enable the authorised officer to carry out his duties under these Regulations;
(b)furnish the authorised officer with such information as the officer reasonably requires for the purpose for which entry into the place has been made.
(2)The inspecting agent in paragraph (1) shall issue the respective inspection completion and certification certificate once satisfied with the inspection.

15. Seizure

(1)During an inspection under these Regulations, an authorised officer may seize any nursing commodity or thing by means of which or in relation to which the officer believes, on reasonable grounds, that these Regulations have been contravened and a full inventory thereof shall be made at the time of such seizure by the officer.
(2)The authorised officer may direct that any nursing commodity or thing seized be kept or stored in the place where it was seized or that it be removed to another place.
(3)Unless authorised by an officer, no person shall remove, alter or interfere in any manner with any nursing commodity or other thing seized.
(4)Any person from whom any nursing commodity or thing was seized may, within thirty days after the date of seizure, apply to the High Court for an order of restoration, and shall send notice containing the prescribed information to the Minister within the prescribed time and in the prescribed manner.

16. Order for restoration

(1)The High Court may order that the nursing commodity or thing be restored immediately to the applicant if, on hearing the application, the court is satisfied that-
(a)the applicant is entitled to possession of the nursing commodity or thing seized; and
(b)the nursing commodity or thing seized is not and will not be required as evidence in any proceedings in respect of an offence under these Regulations.
(2)Where upon hearing an application made under paragraph (1) the court is satisfied that the applicant is entitled to possession of the nursing commodity or thing seized but is not satisfied with respect to the matters mentioned in paragraph (b) of paragraph (1), the court may order that the nursing commodity or thing seized be restored to the applicant on the expiration of one hundred and eighty days from the date of seizure if no proceedings in respect of an offence under these Regulations have been commenced before that time.

Part IV – OFFENCES

17. Obstruction

(1)No person shall obstruct or hinder, or knowingly make a false or misleading statement to an authorised officer who is carrying out duties under these Regulations.
(2)A person who contradicts the provisions of paragraph (1) commits an offence.

18. Offences against the Council

(1)Any person who—
(a)knowingly provides false information to the Council; or
(b)does anything calculated to improperly influence the Council or any authorized officer concerning any matter connected with the exercise of any power or the performance of any function of the Council; or
(c)fails to produce any document or thing in his or her possession or under his or her control lawfully required by the Council to be produced, commits an offence.

19. General penalty

Any person convicted of an offence under these Regulations for which no other penalty is provided shall be liable to a fine not exceeding one hundred thousand shillings, or to imprisonment for a term not exceeding one year, or to both.

20. Nature of offences

(1)Where a corporation, registered society or other similar legal entity commits an offence under these Regulations, any director or officer of the corporation, society or legal entity who acquiesced in the offence commits an offence shall, on conviction, be liable to the penalty provided for by these Regulations in respect of the offence committed by the corporation, society or legal entity, whether or not such corporation, society or legal entity has been prosecuted.
(2)In any prosecution for an offence under these Regulations, it shall be sufficient proof of the offence to establish that the offence was committed by an employee or agent of the accused.
(3)Any act done or omitted to be done by an employee in contravention of any of the provisions of these Regulations shall be deemed also to be the act or omission of theemployer, and any proceedings for an offence arising out of such act or omission may be taken against both the employer and the employee.

21. Nature of evidence in proceedings

(1)In any prosecution for an offence under these Regulations, a copy of any written or electronic information obtained during an inspection under these Regulations and certified to be a true copy thereof shall be admissible in evidence and shall, in the absence of evidence to the contrary, be proof of its contents.
(2)Subject to this Part, a certificate or report purporting to be signed by an officer stating that the officer analyzed anything to which these Regulations applies and stating the results of the analysis, shall be admissible in evidence in any prosecution for an offence under these Regulations without proof of the signature or official character of the person appearing to have signed the certificate or report.
(3)The certificate or report may not be received in evidence unless the party intending to produce it has, before the trial, given the party against whom it is intended to be produced notice of not less than seven days of that intention together with a copy of the certificate or report.
(4)The party against whom the certificate or report provided for under paragraph (3) is produced may, with leave of the court, require the attendance of the officer for purposes of cross examination.
(5)In a prosecution for a contravention of these Regulations—
(a)information on a package indicating that it contains an nursing commodity is, in the absence of evidence to the contrary, proof that the package contains a nursing commodity; and
(b)a name or address on a package purporting to be the name or address of the person by whom the nursing commodity was manufactured is, in the absence of evidence to the contrary, proof that it was manufactured by that person.

FIRST SCHEDULE

[Regulation 2.]

SECOND SCHEDULE

[Regulation 4 (2).]
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History of this document

31 December 2022
22 February 2013 this version

Cited documents 1

Act 1
1. Standards Act 60 citations

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