Tanzania Food and Cosmetics Act, 2003 Regulating Procurement Controlled Drugs

Session 10: Tanzania Food and Cosmetics Act, 2003 Regulating Procurement Controlled Drugs

Total Session Time: 120 minutes

Prerequisites

None

Learning Tasks

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

Define cosmetics, procurement and controlled drugs.

Give explanation of sections in TFDC Act, 2003 which regulate procurement of controlled drugs.

Explain requirements Exception of controlled drugs

State how to document and reporting for controlled drugs.

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

10 minutes

Presentation Buzzing

Definition of Cosmetics, Procurement and Controlled Drugs

3

35 minutes

Presentation

Sections in TFDC Act, 2003 which Regulate Procurement of Controlled Drugs

4

20 minutes

Presentation

Requirements for Exception of Controlled Drugs

5

30 minutes

Presentation

Documentation and Reporting for Controlled Drugs

6

15 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: Definition of Cosmetics, Procurement and Controlled Drugs (10 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 5 minutes

Define the following terms

Cosmetics

Procurement

Controlled drugs

ALLOW few pairs to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMERIZE by using the content bellow

Cosmetic – means any article intended to be used by means of rubbing, pouring, steaming, sprinkling, spraying on or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance and includes any article intended for use as component of a cosmetic; such articles exclude articles intended besides the above purposes for use in the diagnosis, treatment or prevention of diseases and those intended to affect the structure or any function of the body.

Procurement – means buying, purchasing, renting, leasing or otherwise acquiring any goods, works or services by a procuring entity and includes all functions that pertain to the obtaining of any goods, works or services, including description of requirements, selection and invitation of tenderers, preparation and award of contracts.

Controlled substances – means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or

Controlled drug or controlled medicine – means any narcotic drug, psychotropic substance or precursors as listed under Section 77 of the Act; the drugs and prevention of illicit traffic in drugs act 1971

STEP 4: Explanation of Sections in TFDC Act, 2003 which Regulate Procurement of Controlled Drugs (35 minutes)

Section 73; Import and export of drugs, medical devices, herbal drugs or poisons.

Subsection (1) No person, other than a person issued with a licence or permit under the provisions of this Act, may import or export into Mainland Tanzania any drugs, medical devices, herbal drugs or poisons

Subsection (2) Subject to subsection (1), the Authority may if it is in the public interest so to do, authorize parallel importation of any drug.

Subsection (3) Notwithstanding the provisions of this Act, any bona-fide tourist or visitor who enters into, or person normally resident, who re-enters the United Republic, may bring with him such quantity of any drug as may be required during a period of twenty-one days for the medical treatment of himself, or any member, or partner travelling with him.

Subsection (4) No person shall import any drug with shelf life more than twenty four months whose remaining shelf life is less than 60% and a drug with shelf life of less or equal to twenty four months whose remaining shelf life is less than 80%.

Subsection (5) if any person imports any drug, medical devices, herbal drugs or poison, contrary to the provisions of this Act, the Authority may order destruction or re-export of such drug, medical devices, herbal drugs or poisons at his own expenses.

Subsection (6) any person who contravenes the provisions of this section commits an offence and upon conviction shall be liable to a fine of not less than one million or to imprisonment for a term of not less than six months or to both such fine and imprisonment.

Subsection (7) in this section ''parallel importation'' means importing a drug into the country without authorization of the drug registration holder from another country where it is legitimately placed.

Section 74; Sale and administration of drugs subject to prescription by appropriate practitioners

Subsection (1) Subject to the Provisions of this section, no Person shall sell by retail, or supply in circumstances corresponding to retail sale or administer, other than to himself, a drug product of a description or a class specified by order made by the Minister and published in the Gazette except in accordance with a Prescription given by appropriate practitioner.

Subsection (2) In this Part ''appropriate Practitioner'' means a medical practitioner, dentist, veterinary surgeon and any other person as the Minister may by Order published in the Gazette specify.

Subsection (3) Any Person who contravenes the provisions of 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 three months or to both such fine and imprisonment.

Section 75; Prohibition of adulterated or unfit drugs medical devices and herbal drugs

Subsection (1) No Person shall –

add any substance to, or subtract any substance from a drug so as to affect adversely the composition of the drug with intention of selling the drug in that changed state; or

sell or

supply, Or offer or expose for sale or supply, or have in his

Possession for the purpose of sale or supply, any drug, medical devices, herbal drug Or Poison product whose composition has been affected by the addition thereto or subtraction there from of any substance; or

Sell or supply any drug, medical devices, herbal drug or Poison Product which is not of the nature or quality demanded by the Purchaser.

Subsection (2) No person shall –

offer for sale;

Procure for sale;

sell;

Administer to any person or animal, any drug which is unfit for intended Purpose.

Subsection (3) all drugs which are unfit for intended purpose shall be kept in separate place labelled ''unfit for intended use'' marked in red.

Subsection (4) For the purposes of this Act a ''drug which is unfit for intended use'' means a drug which has expired or which is not safe or efficacious or of undesired quality even before the expiry date.

Subsection (5) Where a drug, medical device, herbal drug or poison is sold or supplied pursuant to a Prescription given by an appropriate practitioner, subsection (1) shall have effects as if –

any reference to the ''purchaser'' includes a reference to the person for whom the drug, medical devices, herbal drugs or poisons was prescribed by an appropriate practitioner; and

for the words ''demanded by the purchaser'' shall be substituted by the words ''specified in the prescription''

Subsection (6) any person who contravenes the provisions of this section, commits an offence and shall be liable on conviction –

if such a person is an individual to a fine of not less than five hundred thousand shillings or to imprisonment for a term of not less than three months or to both such fine and imprisonment;

if such a person is an association, or body corporate to a fine of not less than three million shillings.

Section 77;

Subsection (1) The Minister may on advise of the Director General by Order in the Gazette, declare lists of substances Or articles which shall be treated as drugs, herbal drugs, medical devices or poisons for the Purposes of this Act.

Subsection (2) the list of drugs declared under subsection'(1) of this section, shall be divided into but not limited to ''controlled drugs- , Prescription drugs'' and ''general sale drugs

Subsection (3) The Minister may on advise of the Director General in the like manner, amend or vary the list, from time to time, as he deems proper.

Subsection (4) Subject to such conditions as the Minister may prescribe in the regulations made under this Act, any general sale drug may be sold either by way of retail or wholesale in an open shop.

Section 79;

Subsection (1) The Minister on the advice of the Director General may cause the regulations to be published in the Gazette specifying any description or classes of articles or substances which – import, sell or use any controlled drug for medicinal or scientific purpose

are manufactured, sold, supplied, imported or exported in a manner similar to drugs; or

are used as ingredient in the manufacture of drugs; or

If used without proper safeguards, are likely to be a risk to the public health or to be dangerous or injurious to animals.

Subsection (2) The Minister on advice of the Director General shall, provide that subject to such exceptions and modification as may be specified under the provisions of this Act, including those relating to offences and penalties have effect to such description or classes of articles or substances as if those provisions apply to drugs.

STEP 5: Exception of Controlled Drugs (15 minutes)

Donations by individual (s) or organization (s) must adhere to the Guidelines for Donations available free of charge at the TFDA Head office. The following are the requirement condition for exception of controlled drugs;

Application for importation for clinical trial must be accompanied by research protocol.

Four original certificates of official approval to import (annex IV) controlled drugs shall be issued in the following manner:

One certificate shall remain with the Regulatory Authority of the importing country

One certificate shall be accompanied with consignment

One certificate shall remain with the importer

One certificate shall be sent to the Regulatory authority of the exporting country.

Validity of the certificate of official approval of controlled drugs shall be six months from the date of issue. The consignment shall arrive within six months from the date of issue of the certificate of approval for importation.

Every imported consignment containing controlled drugs shall be accompanied with a copy of controlled drugs importation certificate.

Inspection shall be conducted at the port of entry and certificate of importation together with airway bill/bill of lading shall be submitted to TFDA for endorsement.

STEP 6: Documentation and Reporting for Controlled Drugs.(30 minutes)

Record keeping – Every facility permitted by TFDA shall keep complete and accurate

Records of the acquisition and disposition of al controlled drugs. All such records shall be maintained for a period of two (2) years. These records shall include:-

Complete and accurate records of receipt of all controlled substances

Complete and accurate records of disposal of all controlled drugs.

All records pertaining to controlled drugs shall be made available for inspection and copying by the inspectors. These records shall be maintained in such a manner that they are readily retrievable from other documents.

When a facility is permanently closed, the pharmacist in charge shall notify Director General TFDA in writing after within ninety days by what means and as to whom controlled substances were transferred or disposed off.

Narcotic drugs received and issued shall be recorded in a narcotic drug ledger book

Narcotic drugs can be ordered from main pharmacy in small quantities for use in hospital wards and theatre provided that these drugs are kept in a securely locked substantially constructed container or area

Amount received shall be recorded in red ink and amount issued shall be recorded in blue or black ink.

Any error in recording entry in ledger books shall be cancelled once and signed.

Psychotropic substances and precursor chemicals received and issued shall be recorded in a poison book.

Narcotic drugs received and issued shall be recorded in a narcotic drug ledger book

Narcotic drugs can be ordered from main pharmacy in small quantities for use in hospital wards and theatre provided that these drugs are kept in a securely locked substantially constructed container or area

Amount received shall be recorded in red ink and amount issued shall be recorded in blue or black ink.

Any error in recording entry in ledger books shall be cancelled once and signed.

Psychotropic substances and precursor chemicals received and issued shall be recorded in a poison book.

Reporting- Every authorized dealer shall be required to furnish to the authority with the following reports:

Quarterly consumption report

Annual consumption reports and consumption estimates for the coming year.

STEP 6: Key Points (15 minutes)

The meaning of cosmetics, procurement and controlled drugs.

Sections in TFDC Act, 2003 which regulate procurement of controlled drugs.

Requirements Exception of controlled drugs

Documentation and reporting for controlled drugs.

Procurement of controlled drugs is regulated by TFDC Act,2003

Every facility permitted by TFDA shall keep complete and accurate records of the acquisition and disposition of al controlled drugs

STEP 7: Evaluation (5 minutes)

Which requirement is to be followed in order to get exception of controlled drugs?

What is procurement?

Which documentation is so important in controlled drugs?

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

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