Tanzania Food, Drugs and Cosmetics Act, 2003 regulating procurement of medicines and medical supplies

Session 2: Tanzania Food, Drugs and Cosmetics Act, 2003 regulating procurement of medicines and medical supplies

Total Session Time: 120 minutes

Prerequisites

None

Learning Tasks

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

Give the general overview of Tanzania Food, Drugs and Cosmetics Authority (''TFDCA'').

Define the term Food, Drug and Cosmetics.

Mention sections of the Tanzania Food, Drugs and Cosmetics Act, 2003 regulating procurement of medicines and medical supplies.

Give explanation of sections of the Tanzania Food, Drugs and Cosmetics Act, 2003 regulating procurement 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

5 minutes

Presentation

Introduction to TFDCA.

3

20 minutes

Buzzing

Presentation

Definition of the Terms Food, Drug, Medical Devices and Cosmetics

4

30 minutes

Presentation

Functions of the Tanzania Food, Drugs and Cosmetics Authority (TFDC)

5

50 minutes

Presentation

Explanation of Sections of the Tanzania Food, Drugs and Cosmetics Authority Act, 2003 Regulating Procurement of Medicines and Medical supplies.

6

5 minutes

Presentation

Key Points

7

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: Introduction to TFDCA (5 minutes)

There is hereby established the Tanzania Food, Drugs and cosmetics Authority or by the acronym ''TFDCA''.

Consign, convey or deliver for sale or authorise, direct or allow a sale or prepare or possess for purposes of sale, and barter or exchange supply or dispose of to any person whether for a consideration or otherwise.

The Authority shall be an Executive Agency and shall operate in accordance with the Executive Agencies Act, 1997.

The Authority shall have a common seal and the seal of the Authority shall be authenticated /valid by the signature of the Director General or m his absence any person acting on his behalf authorised by him in writing.

STEP 3: Definition of the Terms Food, Drug, Medical Devices and Cosmetics (20 minutes)

Activity: Buzzing (10 minutes)

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

Define the following terms;

Food

Drug

Medical device

Cosmetics

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

''Food'' – means any article other than drugs, cosmetics and tobacco used as food or drink for human consumption and includes any substance used in manufacture or treatment of food.

'Drug'' ''Medicine'' or ''Pharmaceutical product'' – means any substance or mixture of substances manufactured, sold or presented for use in:-

The diagnosis, treatment, mitigation or prevention of a disease, disorder, abdominal physical or mental state, or the symptoms thereof, in man or animal;

Restoring, correcting or beneficial modification of organic or mental functions in man or animal; or

Disinfection in premises in which food and drugs are manufactured, prepared or kept, hospitals, equipment and farm houses;

Articles intended for use as a component of any articles specified in clause (a), (b) or (c); but does not include medical devices or their components, parts or accessories.

''Medical device'' or ''Devices'' – means, an instrument, apparatus, implement, medical equipment, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is –

Recognized in the Official National Formulary, or Pharmacopoeia or any supplement to them;

Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals or;

Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principle intended purposes.

Cosmetics are substances or products used to enhance or alter the appearance of the face or fragrance and texture of the body

STEP 4: Functions of the Tanzania Food, Drugs and Cosmetics Authority (TFDC). (30 minutes)

In according to section five of this Act, the Authority shall be the regulatory body for the products regulated under this Act, and shall in particular to:-

Regulate all matters relating to quality, and safety of food, drugs, herbal drugs, medical devices, poisons and cosmetics;

Regulate in accordance with this Act, the importation, manufacture, labelling, marking or identification, storages promotion, sell and distribution of food, drugs, cosmetics, herbal drugs and medical devices or any materials or substances used in the manufacture of products regulated under this Act;

Ensure that evidence of existing and new adverse events, interactions and information about pharmacovigilance of products being monitored globally, are analyzed and acted upon;

Ensure that, clinical trials on drugs, medical devices and herbal drugs are being conducted in accordance with prescribed standards;

Foster co-operation between the Authority and other institutions or organizations and other stakeholders;

Approve and register products regulated under this Act, manufactured within or imported into, and intended for use in the United Republic;

Examine, grant, issue, suspend, cancel and revoke certificates and licenses or permits issued under this Act;

Appoint inspectors and order inspection of any premises;

Promote rational use of drugs, medical devices and herbal drug;

Establish and maintain the Tanzania National Formulary and Tanzania Pharmacopoeia;

Provide the public with unbiased information on products regulated under this Act;

Prescribe standards of quality in respect of products regulated under this Act, manufactured or intended to be manufactured or imported into or exported from the United Republic;

Maintain registers prescribed under this Act;

Be responsible for its human resource management and development;

Promote, monitor and ensure successful implementation of the provisions of this Act;

Attend to and, where possible, take legal measures on complaints made by consumers against manufacturers of products regulated under this Act;

Carry out such other functions as may be conferred upon the Authority by any written law or as are incidental to the performance of its functions under this Act;

Do such acts or take such measures as are, in the opinion of the Authority, necessary or expedient for the prevention of health hazards to consumers which may result from the consumption or use of low or bad quality products regulated under this Act.

In the performance of its functions, the Authority shall as far as is practicable, maintain a system of consultation and cooperation with:-

Any government institution dealing in atomic energy.

He Inter Ministerial Anti-Drug Commission established by the Drugs and Prevention of Illicit Traffic in Drugs Act, 1995.

The Fisheries and Forestry and Bee keeping divisions in the Ministry responsible for fisheries and bee keeping matters

The Tanzania Bureau of Standards established by Standard Act,1975

The Directorate of Veterinary Services in the Ministry responsible for Livestock Development; or

Anybody or Institution established by or under any other written law and having functions similar to those specified in subsection (1) or having functions which relate to food, drugs, medical devices, herbal drugs.

The Fisheries and Forestry and Bee keeping divisions in the Ministry responsible for fisheries and bee keeping matters;

The Tanzania Bureau of Standards established by Standard Act,1975

The Directorate of Veterinary Services in the Ministry responsible for Livestock Development; or

Anybody or Institution established by or under any other written law and having functions similar to those specified in subsection (1) or having functions which relate to food, drugs, medical devices, herbal drugs

The Fisheries and Forestry and Bee keeping divisions in the Ministry responsible for fisheries and bee keeping matters.

The Tanzania Bureau of Standards established by Standard Act,1975

The Directorate of Veterinary Services in the Ministry responsible for Livestock Development. or

Anybody or Institution established by or under any other written law and having functions similar to those specified in subsection (1) or having functions which relate to food, drugs, medical devices, herbal drugs.

STEP 5: Sections of the Tanzania Food, Drugs and cosmetics Authority Act, 2003 Regulating Procurement of Medicines and Medical Supplies. (50 minutes).

Section 18 – Registration of Premises.

Section 19 – Change of business ownership or any other change.

Section 20 – Application for license or permit.

Section 21 – Types and issuance of licences or permits.

Section 22 – Restriction on dealing in products regulated under this Act.

Section 23 – Exemptions when dealings in drugs.

Section 24 – Exception when supplying and dispensing drugs.

Section 25 – Suspension, variation and revocation of licence or permits.

Section 26 – Licence to sell, supply or dispense specified drugs.

Section 27 – Authority to issue Dispensing Certificates.

The following is explanation of those sections of the Tanzania Food, Drugs and cosmetics Authority Act, 2003 regulating procurement of medicines and medical supplies.

Section 18 – Registration of Premises.

The Director General or any person in his behalf –

Shall register the premises if he is satisfied that the prescribed requirements for which the premises is intended have been complied with

Shall keep registers in the prescribed form of all premises registered under this section.

May, for good and sufficient reasons refuse to register, or may cause to be deleted from the register, any premises which are or have become unsuitable for the purposes for which they were registered,

Shall have the final say on the location and name of the proposed premises

Section 19 – Change of business ownership or any other change.

Any change of ownership of the business or any other change of a registered premises shall be notified to the Authority

Registration of premises registered under section 18 shall cease to have effect upon the expiration of thirty days from the date of changing the ownership of the business of products regulated under this Act.

Section 20 – Application for license or permit.

Shall register the premises if he is satisfied that the prescribed requirements for which the premises is intended have been complied with.

Shall keep registers in the prescribed form of all premises registered under this section.

May, for good and sufficient reasons refuse to register, or may cause to be deleted from the register, any premises which are or have become unsuitable for the purposes for which they were registered.

Shall have the final say on the location and name of the proposed premises.

The premises in which the applicant proposes to manufacture the respective products have been inspected and registered by the Authority for that purpose.

That the substances he intends to use are of a quality satisfactory of the standards prescribed by the Authority in respect of the product he proposes to manufacture.

He has sufficient financial resources such as would enable him, in relation to the manufacture of products regulated under this Act, to maintain the standards of quality prescribed by or under this Act;

That he has not, within twelve months immediately preceding his present application, been convicted of an offence under this Act or any other written law relating to quality standards of products regulated under this Act;

That he is not disqualified in any other way from holding a license or a person whose licence is suspended;

That he has adequate expertise or skill or has personnel qualified to execute the business for which he is seeking to be licensed;

That he has adequate facilities such as would enable him to maintain the standards of quality prescribed in relation to the manufacture of the products for which he is seeking to be licensed.

That he meets in all respects such other requirements which may be prescribed in respect of manufacturers of products regulated under this Act;

The premises on which products regulated under this Act, of the description to which the application relates will be stored;

The equipment are available for storing the products regulated under this Act on those premises;

Suitability of the equipment and facilities which are used for distributing the products regulated under this Act;

The arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of products regulated under this Act stored in or distributed from those premises;

If the Authority is satisfied that it is in the public interest that a license to sell product under this Act should be issued or renewed, the Authority may, on application made to it in writing on prescribed forms, and on payment of the prescribed fee, issue to the applicant a license in the form prescribed, or renew the licence as the case may be.

A separate license under this section shall be required in respect of each set of premises in which the business is carried on.

Section 21 – Types and issuance of licences or permits.

The Authority, shall subject to sub section (2) upon an application made, issue the following licenses or permits

Manufacturing licence;

Wholesale licence;

Retail licence; or

Any other licence or permit as the Authority may deem fit for the purpose of this Act.

If the Authority is satisfied that the applicant is a fit and proper person to carry on any business set out in sub section (1) may issue to the applicant the licence or permit appropriate to such business subject to such general or special conditions as the Authority may consider appropriate to impose.

A licence or permit issued under subsection (I) shall be in the form and manner as set out in the regulations made under this Act.

Where the Authority considers that the applicant is not fit and proper person to whom a licence or permit should be issued for carrying on of any business specified under this section it shall refuse to issue a licence.

Section 22 – Restriction on dealing in products.

Notwithstanding the provisions of this Act or any other written laws, no person shall, on or after the appointed day, manufacture for sale, sell, offer, supply or import any product regulated under this Act unless –

The product is registered in accordance with the provisions of this Act;

The person holds the appropriate licence or permit required and issued by the Authority.

No person shall in the course of any business carried on by him –

Sell or manufacture any product regulated under this Act except in accordance with a licence granted for that purpose; or

Manufacture or assemble any product regulated under this Act except in accordance with a manufacturer's licence granted for that purpose; or

Sell, supply, import or export any product by way of wholesale dealing or retail except in accordance with licence or permit granted by the Authority for that purpose.

Any person who contravenes the provisions of this section relating to the manufacture, importation or wholesale of products regulated under this Act, commits an offence and upon conviction shall be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding two years or to both such fine and imprisonment.

Any person, who contravenes the provisions of this section relating to retail sale of products regulated under this Act, commits an offence and upon conviction is liable to a fine not exceeding five hundred thousand shillings or to imprisonment for a term not exceeding three months or to both such fine and imprisonment.

Section 23 – Exemptions when dealing in drugs.

23.-(I) the provisions of section 22 shall not apply to –

Relates to a drug product specially prepared for administration or supply to his particular patient; or

Relates to a drug product specially prepared by that dentist at the request of another dentist for administration to a particular patient of that other dentist; or

Relates to a drug product specially prepared by that medical practitioner at the request of another medical practitioner for administration to a particular patient of that other medical practitioner.

Anything done by a veterinary surgeon which –

relates to a drug product specially prepared for administration to a particular animal which is under his care; or

relates to a, drug product specially prepared by him at the request of another veterinary surgeon for administration to a particular animal or group of animals under the care of that other veterinary surgeon;

Anything which is done in a pharmacy and is done by or under the supervision of a pharmacist and consists of preparing, dispensing, assembling or procuring a drug product in accordance with a prescription given by a medical practitioner, dentist or a veterinary surgeon;

anything which is done in a pharmacy by or under the supervision of a pharmacist and consists of –

preparing or dispensing a non-prescription drug for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist own judgment as to the treatment required and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed;

preparing a stock of drug products with a view to dispensing them as mentioned in paragraph (c) or in paragraph (d)(i);

Anything which is done in a hospital pharmacy by or under the supervision of a pharmacist and consists of preparing a stock of drug products with a view to dispensing them as mentioned in paragraph (c); or

The importation of a drug product by any person for administration to himself or to any persons who are members of his household or the importation of a drug product where it is specially imported by or to the order of a medical practitioner or dentist for administration to his patient:

Provided that, either case the quantity so imported shall be not greater than is reasonably necessary for the purpose and is not of commercial value; or

The importation of a drug product in such circumstances as maybe specified by the Authority;

The importation of any drug, medical devices or poison for purposes of research institution; or for the purpose of obtaining samples for registration.

Anything done by a traditional health practitioner registered under the Traditional and Alternative Medicines Act, 2002, which relates to a herbal drug specifically prepared for administration, or supply to this particular patient.

Section 24 – Exception when supplying and dispensing drugs.

24-(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 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.

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.

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 25 – Suspension, variation and revocation of licence or permits.

25. – (1) Subject to Sub Part C, the Authority may suspend a licence for such period as it may determine, or may revoke, or vary any provisions of such licence.

The suspension or revocation of a licence or permit under this section may be limited to products of one or more descriptions, or to any particular premises or to a particular part of any premises.

The Authority may, on the application by the holder of a licence or permit under this Part, vary the provisions of the licence or permit in accordance with any proposals contained in the application, if the Authority is satisfied that the variation will not affect the safety, quality or efficacy of such products.

Section 26 – Licence to sell, supply or dispense specified drugs.

26.-(I) Notwithstanding any of the provisions of this Act, relating to sell, supply 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.

Section 27 – Authority to issue Dispensing Certificates.

27.-(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 practising medical practitioner, dentist or veterinary surgeon to dispense drugs, which he is entitled to prescribe.

Upon application being made to the Authority pursuant to sub section (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.

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.

In this section ''public interest'' means and includes facilitation of accessibility of the public to drugs within a specified area.

STEP 6: Key Points (5 minutes)

The Tanzania Food, Drugs and Cosmetics Authority (TFDCA) is an Executive Agency under the Ministry of Health, Community Development, Gender, Elderly and Children

The Tanzania Food, Drugs and Cosmetics Authority (TFDCA) is responsible for the control of quality and safety of food, drugs, cosmetics and medical devices for the purpose of protecting public health

TFDCA is established under Section 4 (1) of the Tanzania Food, Drugs and Cosmetics Act, 2003

STEP 7: Evaluation (5 minutes)

What are the Functions of the Tanzania Food, Drugs and cosmetics Authority (TFDC)?

What do the following terms mean?

Food

Pharmaceutical product

Cosmetics

According to Tanzania Food, Drugs and Cosmetics Authority Act, 2003 which pharmacy licenses or permits are issued by Tanzania Food, Drugs and Cosmetics Authority?

References

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

Embrey, M. A. (2013). MDS-3: Managing access to medicines and health technologies. Sterling, VA: Kumarian Press.

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