Health Care Regulations for MSMEs
The National Health Policy (2007)
This emphasizes the importance of Public Private Partnership (PPP) in health service provision in Tanzania. The Health Sector Strategic Plan III (HSSP III, 2009-15) which was jointly developed by private and public health leaders, transfers this important role of the private sector into three strategic focal areas at a more operational level, e. g. ensure effective implementation of health Public and Private Partnerships. In this context, within the Sector Wide Approach (SWAp) in 2009 a Public Private Partnership Working Group was established in order to coordinate and steer respective activities in this health.
The Private Hospitals (Regulation) Act, 1992
This was established as an amendment of 1977 private hospitals’ principal act, whereby it gives instruction on how to conduct medical businesses. Only qualified and approved person is allowed to manage hospitals and offer medical services. The act gives the board established under it (Private Hospitals Advisory Board) the mandate to give licenses of carrying out private hospital business.
Private Health Laboratories Regulations Act, 1997
The Act enacted specifically to regulate the registration and management of private health laboratories managed by approved persons (For the health laboratory assistant has to have a certificate of health laboratory training, for health laboratory practitioners are health laboratory scientist with degree/advance diploma of health laboratory sciences, and health laboratory technologist with diploma in health laboratory sciences) and all services to be offered by these laboratories.
The board made under this Act (Private Laboratories Board), sets the associated fees and issuing certificates of registration to the accepted applications, and does all private health laboratory approval and registrations. The board also has been given the power to revoke any issued registration if there was breaking of the law and other related formalities. The law explains that only professional approved person or organizations will be registered and given license to run private health laboratory
The Tanzania Food, Drugs, and Cosmetics Act, 2003
The Act established for the sake of efficiently and comprehensively regulating and controlling quality and safety of food, drugs, medical devices, cosmetics, herbal drugs, poisons, and other associated services and products. Authority established under this act, plays the roles of setting quality standards and issuing certificate of operating business activities concerning foods, drugs, medical devices, herbal drugs, and cosmetics. It also controls the manufacturing, importation, exportation, selling, and distribution of food, drugs, cosmetics and medical devices intended for human consumption and uses.
Procedures for Importation
i) Filling import application form addressed to the Director General, TFDA
ii) Submission of applications at the headquarters of TFDA (Dar es Salaam) or zone offices located in Arusha, Mwanza, Mbeya and Dodoma regions.
iii) The application form shall be accompanied by one original proforma invoice and two (2) copies of original invoice from the marketing authorization holder of the product(s) or authorized supplier(s), subject to provision of the original proforma at the time of importation.
The Proforma invoices shall state for each pharmaceutical OR Health product to be imported, shall state the following;
(a) Pro-forma invoice number and date
(b) Name of the supplier
(c) Name of the manufacturer
(d) Country of origin
(e) Trade or proprietary name
(f) The International Non Proprietary name (generic name) of the drug and its strength
(g) In the case of the product containing more than one active ingredient, the name and strength of each shall be stated
(h) The pharmacopoeia specification of the ingredient such as BP, USP
(i) The product registration number issued by the Tanzania Food and Drugs Authority.
(j) The quantity to be imported for each drug, its unit value, total value and acceptance currency.
(k) Batch number for each product
(l) Manufacturing and expiring date
(n) Mode of shipment (sea, air, road)
(o) Destination port of entry
(p) Expected date of arrival
(q) Signature and stamp of the supplier
iv)Application form (Annex I) shall be stamped and signed by the pharmacist or veterinary surgeon in-charge of the importing company before submission to TFDA. In case this doesn’t apply the application form shall be signed by applicant
v) Import permit shall be valid for six (6) months, not transferable and issued to cover only one shipment.
vi) In case of partial shipments, only two shipments may be allowed based on the initial import permit.
a) All pharmaceutical products to be imported must be registered by TFDA unless given special approval by the Authority.
b) All importation of pharmaceutical products must be done by importers whose premises are dully registered by TFDA or relevant Government institution.
c) All importers must import pharmaceutical products through the authorized Port of Entry (POE)(see section 1.7(4).
d) In case of donations, importer must have a donation certificate and adhere to the Guidelines for Donations. The donated pharmaceutical products must be fit for human consumption, safe and of good quality and not prohibited in the country of origin.
e) No person shall import any pharmaceutical product with shelf life of more than twenty four months whose remaining shelf life is less than 60% and a drug with shelf life of less or equal to
Requirements for Exporting
• No person shall export pharmaceutical products out of the country without having a valid export permit issued by the Authority. (TFDA)
• All pharmaceutical products to be exported must come from a registered manufacturer or wholesale pharmacy in Tanzania Mainland.
• All exporters must export pharmaceutical products through the authorized Port of Entry
Guidance on Compliances for Health Care MSMEs
All health care practitioners are supposedly to comply with the guidelines proposed in those mentioned laws and regulations. Apart from that they are also required to register and run their business in ways that have been approved to be legal.
Investment Opportunity(s) for Health Care MSMEs
The Tanzania Investment Centre (TIC) provides accurate and relevant information regarding the opportunities and procedures for investing in Tanzania. TIC offers answers on a wide range of questions such as the reasons for investing in Tanzania; how to start up a business; how to enter the country; where to invest, how to invest and how to obtain business support and incentives.
In Health care sector the Government of Tanzania in association with several stakeholders has continued to pursue improvements on availability along with the standards of health services. Reproductive and child health services are among key priority areas with an intention to reduce maternal and child mortality rate. Besides the achievements made, there are still some areas that need further improvements, such as the number of health care facilities and skilled health care workforce. Improvements in health care can open up MSMEs opportunities in establishing more private health centers and dispensaries, additional medical training facilities, modern diagnosis and health service equipment, extra ambulances and other life-saving items, plus other facilities that will enhance government capacity in its objective to improve the accessibility and quality of health services. Some specific investment areas in Health care Sector include:
a) Creating mechanisms and methods for care and rehabilitative treatment services at all levels
b) Providing resources to facilitate the construction and rehabilitation of health facilities at all levels
c) Offering housing and other incentives for public health workers
d) Providing training for health personnel (medical doctors, nurses and paramedical graduates, laboratory technicians)
e) Offering health tools and equipment at all levels
f) Establishing pharmaceuticals and offering drugs for curative and preventive measures
g) Providing health information systems to facilitate efficient health planning and programs
Local Government By-Laws on Health Care and other related MSMEs
The local government Authorities has powers to formulate their own By-Laws within their area of jurisdiction. These powers are guaranteed by Local Government (District Authorities) Act CAP 287 and Local Government (Urban Authorities) Act CAP 288 (RE 2002). These acts provide the procedures under which district councils and Urban Authorities can make by- laws. They differ from area to area therefore Healthcare MSMEs must be aware of existing By-Laws in the area they operate their business.
Health Care Exhibition/Fairs for MSMEs
The following is an updated List of International Health Care fair for the year 2016 that MSMEs can explore:
a) Kenya Medical Show, Nairobi start from 18th – 20th February 2016, Oshwal Center Nairobi
b) Kenya Africa Pharmaceutical Summit East, Nairobi: 24/02/2016 – 25/02/2016 from 7:00 am – 5:00 pm. Location: Safari Park Hotel
c) Ethiopia Ethio Health International Healthcare Exhibition and Congress, from 11th March to the 13th March 2016 at the ADDIS ABABA MILLENIUM HALL in Addis Ababa, Ethiopia.
d) Tanzania Medafro East Africa International Trade Show on Medical and Health, Dar es Salaam: from 18 – 20 March 2016, at Diamond Jubilee Hall , Dar-es-Salaam, Tanzania.
e) Egypt Mediconex Int’l Medical Exhibition, April 05-07, 2016, Cairo, Egypt at Cairo International Convention and Exhibition centre Cairo
f) International Pharmacy and Parapharmacy Exhibition in Algiers Palais des Expositions d’Alger 18.02 – 20.02 2016, Algeria
g) Simem International Trade Fair for Medical Equipment and Pharmaceuticals, it is done once a year at Le Méridien Oran Hotel & Convention Centre 13.04 – 16.04 2016, Algeria
h) SIEHM Medical & Hospital Equipment International Expo once a year Algiers Palais des Expositions d’Alger May 2016 (date not yet published)
i) South Africa Health Exhibition Healthcare Expo and Conference, June 08-10, 2016, Midrand, South Africa
j) Kenya Medexpo Kenya International Trade Exhibition on Medical and Pharmaceutical Products, Equipment and Machinery, November 17-19, 2016, Nairobi, Kenya, KICC – Kenyatta International Conference Centre Nairobi
k) Tanzania Medexpo International Trade Exhibition on Medical and Pharmaceutical Products, Equipment and Machinery, December 01-03, 2016, Dare s salaam, Tanzania