Tanzania
Private Health Laboratories (Regulation) Act
Private Health Laboratories (Conditions Pre-requisite to Registration and Management) Regulations, 1998
Government Notice 399 of 1998
- Published in Tanzania Government Gazette
- Commenced on 1 July 1998
- [This is the version of this document at 31 July 2002.]
- [Note: This legislation has been thoroughly revised and consolidated under the supervision of the Attorney General's Office, in compliance with the Laws Revision Act No. 7 of 1994, the Revised Laws and Annual Revision Act (Chapter 356 (R.L.)), and the Interpretation of Laws and General Clauses Act No. 30 of 1972. This version is up-to-date as at 31st July 2002.]
Part I – Regulations (regs 1-10)
1. Short title
These regulations may be cited as the Private Health Laboratories (Conditions Pre-requisite to Registration and Management) Regulations.2. Interpretation
In these Regulations, unless the context requires otherwise—"the Act" means the Private Health Laboratories Regulation Act1;"approved person" means a registered health laboratory technologist or a pathologist approved by the Board to manage a private health laboratory in accordance with the provision of the Act;"Board" means the Private Health Laboratories Board established under section 4 of the Act;"commencement date" means the 1st day of July 1998;"group A laboratory" means a referral health laboratory for group B1 laboratories which is attached to a Tertiary Hospital or may operate as an autonomous Private Health Laboratory;"group A multipurpose laboratory" means any group A laboratory which operates health laboratory services in two or more of the following disciplines of the laboratory speciality:Clinical ChemistryHaematology and Blood Transfusion;Histopathology and Cytology;Microbiology and Immunology;Parasitology and Medical Entomology;Any other speciality as approved from time to time by the Board;"group A single purpose laboratory" means a health laboratory which operates with one discipline of the laboratory speciality;"group B1 laboratory" means the referral health laboratory for group B2 laboratories which is attached to a secondary hospital or may operate as an autonomous private health laboratory;"group B2 laboratory" means the first referral health laboratory for group C laboratories which is attached to a primary hospital or can operate as an autonomous private health laboratory;"group C laboratory" means health laboratory services which is attached to a dispensary or health centre or can operate as an autonomous private health laboratory;"health education" means provision of information on laboratory investigations;"private health laboratory services" means services provided by a health laboratory to an individual and the community and includes clinical chemistry, haematology and blood transfusion, histopathology and cytology, microbiology and immunology, parasitology and medical entomology and research, health education and the provision of laboratory investigation supplies;"Registrar" means the Registrar of the Private Health Laboratories Board appointed under section 9 of the Act.3. Establishment, operation and management of a private health laboratory
4. Regional laboratory technologist to become an Assistant Registrar
Subject to subsection (4) of section 9 of the Act, the regional laboratory technologist shall be the Assistant Registrar.5. Authorized officers to inspect equipment and chemicals
All health laboratory equipment, reagents and chemicals imported or distributed in the country shall be subject to inspection by officers authorized by the Board.6. Defective equipment, reagents and chemicals to be destroyed
If health laboratory equipment, reagents and chemicals are defective and/or expired, the Board shall cause them to be destroyed at the expense of the owner.7. Accidents to be recorded
All Private Health Laboratories shall—8. Mechanism of receiving complaints to be set
The Board shall set mechanisms of receiving complaints of poor laboratory investigation services and proper action shall be taken in accordance with provision of subregulation (10) of regulation 3 of these regulations.9. Appointment of permanent and temporary officers
The Board may from time to time by resolution appoint such permanent or temporary officers as they may deem to be necessary and may remunerate such officers by way of salary.10. Training for members and staff
The Board shall make sure that its members and staff are trained regularly in order to perfom their duties efficiently.Part II – The Private Health Laboratories (Material and Supplies (regs 11-27)
11.
Except as otherwise provided in these regulations, no person shall manufacture, sell, supply, import or export any health laboratory supply unless—12.
13.
14.
The Board may require any person applying for permit of any imported laboratory supplies to furnish a written declaration made by or on behalf of the manufacturer of the product that all the legal requirements governing the manufacture of such product imposed by the laws of the country of manufacturer have been complied with.15.
The Board may without giving any reason, reject any application for permit of any laboratory product.16.
The Board may at any time and without assigning any reason suspend or cancel the permit certificate of any laboratory supplies and may cancel conditions to which such permit is subject.17.
The laboratory chemicals or reagents manufacturing laboratory or plant should not be in the same building with living premises, hotel, bar, restaurant, hair salon and other commercial or entertainment activities.18.
The registration permit for rendering health laboratory services in terms of provisions of laboratory supplies whether as a manufacturer, retail or whole seller, representative, importer or exporter, shall be renewed annually.19.
Any person who needs to import or export specimens shall make sure that the specimens are put in a sealed and leak-proof container and placed in a polythene bag similarly well sealed. Specimens sent by post shall obey post office regulations and contained in a plastic bag surrounded by absorbent material and then packed in a strong cardboard box or plastic container.20.
The Board after scrutinizing permit requests shall recommend to the licensing authority whether or not a person may be issued licence for importing, exporting, selling, manufacturing or operating as a company representative for any of the health laboratory supplies.21.
No person shall be issued a licence to deal with any of the provisions of the health laboratory supplies unless he has received recommendations from the Registrar of the Private Health Laboratories Board.22.
Where a person is convicted of an offence under the Act, such conviction shall entail automatic revocation of his permit and this shall be a ground of refusal to review the permit after one year.23.
Every permit shall be personal to the permittee named therein and shall not be transferable to another person.24.
Every application for permit to import any health laboratory product listed in the national health laboratory supplies list shall be in a form PHL FORM B set out in the Second Schedule to these regulations and shall be accompanied by fees prescribed by the Third Schedule of these regulations.25.
26.
27.
Any person convicted of an offence under Part II of these regulations is liable to a fine of not less than two hundred thousand shillings and not exceeding five hundred thousand shillings or to imprisonment for a term not less than six months or both fine and imprisonment.Part III – Manufacture of health laboratory supplies or products (regs 28-35)
28.
29.
30.
Every permit shall be personal to the permittee named therein and shall not be transferable to another person.31.
32.
33.
Any person who refuses or fails to comply with the provisions of Part III of these regulations commits an offence.34.
Any person convicted of an offence under regulation 33 of these regulations is liable to a fine of not less than two hundred thousand shillings or to imprisonment for a term not less than six months or both fine and imprisonment.35.
Where a person is convicted of an offence under regulation 33 of these regulations, such conviction shall entail automatic revocation of his permit and it shall be a ground of refusal to review the permit after one year.Part IV – Medical representative/dealer/retail seller for health laboratory supplies (regs 36-40)
36.
37.
38.
The Board may issue such directions to any medical representative/retail seller for the health laboratory supplies as it thinks necessary, for the better carrying out of the provisions of these regulations and which may be in particular related to the recall of any laboratory product from the market and the disposal of any product.39.
Any person who refuses or fails to comply with the provisions of Part IV of these regulations commits an offence.40.
Subject to regulation 39 any person convicted of an offence is liable to a fine of not less than two hundred thousand shillings or to imprisonment to a term of not less than six months or both fine and imprisonment.Part V – Importation of health laboratory products (regs 41-42)
41.
42.
Any person convicted of an offence under regulation 41(6) of these regulations is liable to a fine of not less than two hundred thousand shillings or imprisonment to a term not less than six months or both fine and imprisonment.History of this document
31 July 2002 this version
Consolidation
01 July 1998
Commenced
Cited documents 2
Legislation 2
1. | Private Health Laboratories (Regulation) Act | 3 citations |
2. | Private Hospitals (Regulation) Act | 2 citations |