Tanzania Food and Cosmetics Act, 2003 Regulating Distribution and Use of Medicines and Medical Supplies

Session 20: Tanzania Food and Cosmetics Act, 2003 Regulating Distribution and Use of Medicines and Medical Supplies

Total Session Time: 60 minutes

Prerequisites

None

Learning Tasks

By the end of this session students are expected to be able to:

Define

Distribution of medicine and medical supplies

Medicine administer

Explain sections in TFDC Act, 2003 which regulates distribution, use of medicines and medical supplies.

Resources Needed:

Flip charts, marker pens, and masking tape

Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

Step

Time

Activity/

Method

Content

1

5 minutes

Presentation

Introduction, Learning Tasks

2

15 minutes

Buzzing

Presentation

Definition of Distribution and Administration of Medicines and Medical Supplier

3

30 minutes

Presentation

Explanation of Sections in TFDC Act, 2003 which Regulate Distribution, Use of Medicines and Medical Supplies.

4

5 minutes

Presentation

Key Points

5

5 minutes

Presentation

Evaluation

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning Tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Terms. (15 minutes)

Activity: Buzzing (20 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

What does distribution of medicines mean?

What is administration of medicines and medical supplies?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

Distribution – means a business of dealing in human medicines or medical devices in bulk or wholesale but does not include importers of human medicine, medical devices, food, cosmetics and veterinary medicines.(Pharmacy Act,2011)

Administer – means administering of substance or article to a human being or an animal whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not and any reference in this Act to administering a substance or article shall be construed as a reference to administering it either in its existing state or after it has been dissolved or dispersed in, sprayed, or diluted or mixed with, some other substance used as a vehicle for such administration.(TFDC Act,2003)

STEP 3: Sections in TFDC Act, 2003 which Regulate Distribution, Use of Medicines and Medical Supplies. (45 minutes)

Section 24- supplying and dispensing drugs

Subsection (1) A medical practitioner, dentist or veterinary surgeon, or a member of the staff of a hospital, dispensary or similar institution who has been authorized to do so by the general or special order of the Minister, on the advice of the Authority may supply or dispense a prescription drug for the purpose of medical, dental or veterinary treatment, as the case may be, subject to the following conditions –

The drug shall be distinctly labelled with the name and address of the person by whom it is supplied or dispensed;

The following particulars shall, within twenty four hours after the drug has been supplied or dispensed, be entered in a book used

Regularly for the purpose, and which shall be called the Prescription Book

the date on which the drug was supplied or dispensed;

the name, strength and the quantity supplied;

the name and address of the person to whom the drug was supplied;

The name and address of the person by whom the prescription was given.

Subsection (2) where an authorized seller of drugs supplies a prescription drugs, shall enter its particulars in a Prescription Book kept in accordance with the provisions of this section.

Subsection (3) Any person to whom subsection (1) applies and who supplies or dispenses any prescription drug in a manner contrary to this section, commits an offence and upon conviction is liable to a fine of not less than one hundred thousand shillings or to imprisonment for a term not exceeding one month, or to both such fine and imprisonment.

Section 26.Licence to sell, supply or dispense.

Subsection (1) Notwithstanding any of the provisions of this Act, relating to sell, supply or dispensing of drugs and if it is in the public interest so to do, the Minister may, on advise of the Authority and by order published in the Gazette, allow any person or group of persons to be licensed by the Authority to sell, supply or dispense such drugs as may be specified and under such conditions as may be prescribed in the regulations.

Subsection (2) The Minister may in addition to any other conditions, require such a person to possess specified qualifications or training as the case may be.

Section 27.Authority to issue dispensing certificate specified drugs.

Subsection (l) The Authority may, when it is in the public interest and upon an application being made in a prescribed manner and subject to such conditions as may be prescribed in the regulations made under this Act, issue a dispensing certificate to a practicing medical practitioner, dentist or veterinary surgeon to dispense drugs, which he is entitled to prescribe.

Subsection (2) upon application being made to the Authority pursuant to subsection (1), the Authority may issue a dispensing certificate subject to such conditions as it may deem necessary and for such duration of time as it may prescribe.

Subsection (3) The Authority may, where it is satisfied that the applicant did not or is not fulfilling the conditions issued by it may suspend, revoke or withdraw the dispensing certificate issued under subsection (1) of this section

Subsection (4) in this section ''public interest'' means and includes facilitation of accessibility of the public to drugs within a specified area.

Section 86. No cosmetics shall be sold, given, manufactured, imported, stored or exhibited for the purpose of being sold or given unless the cosmetic conforms to requirements prescribed by the Authority.

Section 88. No person shall himself or by any other person on his behalf –

sell, supply or distribute cosmetics that contain poisonous or harmful substances that might injure users under normal conditions;

manufacture or hold cosmetics under insanitary conditions , using non-permitted colours, or including any filthy,putrid or decomposed substance

Sell, or stock or exhibit or offer for sale or distribute any cosmetic which has been imported or manufactured in contravention of any of the provisions of this Act.

Section 90. Without prejudice to any other provisions contained in this Act, if the Minister on advice of the Director General is satisfied that the use any cosmetic is likely to involve any risk to human being or that it contains ingredients of such a type and quantity which there is no justification and that in the public interest it is necessary or expedient to prohibit, the Minister may, by notification in the Gazette prohibit the importation, manufacture and sale of such a cosmetic.

Section 91. Offences and penalties

Any person whether himself or on behalf of another person manufactures, imports, sells or distributes –

any counterfeit cosmetic as referred to in the provision of section 89, commits an offence and upon conviction is liable to a fine not exceeding one million shillings or to imprisonment for a term not exceeding six months or both such fine and imprisonment;

any cosmetic other than cosmetic referred to under the provisions of section 88, the import of which is prohibited, commits an offence and upon conviction is liable to a fine of not less than five hundred thousand shillings or to imprisonment for a term of not less than three months or both such fine and imprisonment.

STEP 6: Key Points (5 minutes)

Distribution – means a business of dealing in human medicines or medical devices in bulk or wholesale but does not include importers of human medicine, medical devices, food, cosmetics and veterinary medicine

Administer – means administering of substance or article to a human being or an animal whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not and any reference in this Act to administering a substance or article shall be construed as a reference to administering it either in its existing state or after it has been dissolved or dispersed in, sprayed, or diluted or mixed with, some other substance used as a vehicle for such administration.(TFDC Act,2003)

STEP 7: Evaluation (5 minutes)

What do you understand by the term drugs distribution?

What does administration of medicines mean?

Which sections of TFDA Act, 2003 regulate distribution, use of medicines and medical supplies?

References

MSH and WHO (2012) Managing Access to Medicines and Health Technology, 3rd Edition. Kumarian Press

MoHSW (2003) Tanzania, Food, Drugs and Cosmetics Act, Government Printers Dar es Salaam

MoHSW (2011), Pharmacy Act, Government Printers Dar es Salaam

United Republic of Tanzania (1971), the drugs and prevention of illicit traffic in drugs act, Government Printers Dar es Salaam

United Republic of Tanzania (2011). Public Procurement Act, Dar es Salaam

MoHSW (2003). The National Health Policy, Government Printers Dar es Salaam

MoHSW (1991). The National Drug Policy, Government Printers Dar es Salaam

United Repulic of Tanzania (1993).Medical Stores Department Act, Government Printers Dar-es-salaam

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