Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for

Dispensation of Medicines)
GN. NO. 185 (contd)

GOVERMENT NOTICE NO. 185 published on 15/3/2019

THE PHARMACY ACT

(CAP. 311)

THE PHARMACY (ACCREDITED DRUGS DISPENSING OUTLETS) (STANDARDS AND

ETHICS FOR DISPENSATION OF MEDICINES) REGULATIONS, 2019

ARRANGEMENT OF REGULATIONS

Regulation Title

PART I
PRELIMINARY PROVISIONS

1.Citation
2.Application
3.Interpretation

PART II
ESTABLISHMENT AND MANAGEMENT OF OUTLET

4.Objective for establishment of Outlet

5.Establishment and composition of CFDC
6.Functions of the Committee
7.Vesting of mandate of Ward Health Committees

PART III
REGISTRATION CERTIFICATE AND BUSINESS PERMIT
8.Restriction for operation of Outlet
9.Application for Accreditation
10. Scrutinization of applications by Committee
11. Submission of report and recommendation to Council
12. Determination of recommendation
13. Accreditation and issuance of permit
14. Re-accreditation of Outlet

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15. Refund of fees chargeable

16. Conditions of operation of Outlet
17. Revocation and cancellation of certificates and permits
18. Surrender of certificates and permits
19. Restoration of name to the register

PART IV
STANDARDS OF OPERATION
(a) Personnel

20. Qualification of Outlet Dispenser

21. Dispenser Training Course
22. Services to be provided at Outlet
23. Categories of ADDO dispensers
24. Conduct of ADDO Dispensers
25. Contract between owner and ADDO dispenser
26. ADDO owner’s requirements
27. Occurrence of theft
28. Awareness program for ADDO Owners
29. Continuing education for ADDO dispenser

(b) Location and Premises Requirements

30. Location of ADDO premises

31. Design and description of ADDO Premises
32. Products for dispensation at ADDO
33. Removal of labels and repackaging
34. Dispensation of registered pharmaceutical products

(c) Record Keeping and Documentation

35. Invoices, receipts and ledger book

36. Dispensing Register
37. Register for expired products
(d) Wholesale Obligation

38. Obligation of wholesalers

39. Establishment of ADDO Restricted Wholesale
40. Registration and permit for ADDO Restricted Wholesale

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41. Responsibilities of ADDO Restricted Wholesale

PART V
INSPECTION AND SUPERVISION
(a) Supervision Levels
42. Mandate of Supervision
43. Inspection at Ward level
44. Inspection at District level
45. Inspection at Regional Level
46. Inspection at National level
(b) Inspection of Outlets
47. Appointment of inspectors
48. Complaints against inspection
49. Determination of complaints
50. Powers of the Council in relation to inspectors
51. Declaration of interest
52. Conduct of inspection
53. Quarterly reports
54. Inspection Supervision and Monitoring

PART VI
OUTLET ETHICS AND CONDUCT

55. Construction of code of ethics and conduct

56. Honest and integrity
57. Duty of care to patients
58. Special relation with patients
59. Confidentiality
60. Restrictions to DLDM dispensers on quality services
61. Collaboration with other health care providers
62. Competence building by ADDO dispensers
63. Health promotion
64. Restriction on commercial relationship
65. Breach of ethics and conduct

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PART VII
GENERAL PROVISIONS
66. Compounding of offences
67. Fees and charges
68. Offences and penalties
69. Revocation and savings provisions

____________

SCHEDULES
___________

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THE PHARMACY ACT

(CAP.311)
______

REGULATIONS
____

(Made under section 55(r))

____________

THE PHARMACY (ACCREDITED DRUGS DISPENSING OUTLETS) (STANDARDS AND

ETHICS FOR DISPENSATION OF MEDICINES) REGULATIONS, 2019

PART I
PRELIMINARY PROVISIONS

Citation 1. These Regulations may be cited as the Pharmacy (Accredited

Drugs Dispensing Outlets) (Standards and Ethics for Dispensation of
Medicines) Regulations, 2019.

Application 2. These Regulations shall apply to-

(a) every person or group of persons permitted or otherwise allowed
by the Minister to dispense medicines or operate an Outlet
pursuant to section 40 of the Act;
(b) every Outlet accredited pursuant to these Regulations.

Interpretation 3. In these Regulations, unless the context otherwise requires:

Cap. 311 “Act” means the Pharmacy Act;
“ADDO Prescription Medicines” means medicines prescribed under the Fifth
Schedule of the Tanzania Food Drug and Cosmetic (Scheduling of
Medicines) Regulation 2015;
GN No. 63 of
2015
“business permit” means a permit issued in terms of regulation16(1) to
operate an Outlet;
“Committee also prescribed as CFDC” means the Council Food and Drug
Committee established pursuant to these Regulations;
“Council” means the Pharmacy Council established under section 3 of the
Act;
“Outlet” also prescribed as “ADDO”, “DLDM” or “Duka la Dawa Muhimu”
means premises accredited under these Regulations to provide
drugs dispensing services to the communities in rural or peri-urban
areas;
“dispenser” means a person who is permitted to work as a dispenser of
medicines at an Outlet subject to the provisions of these
Regulations;
“Certificate” means a dispensing certificate awarded to a dispenser as
provided under regulation 26;
“health care worker” means a person who holds a basic knowledge in
medical, pharmaceutical or related qualifications as recognized by
the respective Council or Board;
“owner” means the proprietor of an Outlet;
“over the counter medicines” also described as “OTC medicines” means

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medicines prescribed under the Third Schedule of the Tanzania

GN No. 63 of Food Drug and Cosmetic (Scheduling of Medicines) Regulation
2015 2015;
“pharmaceutical personnel’’ means a registered pharmacist, enrolled
pharmaceutical technician or enlisted pharmaceutical assistant and
recognized medicine dispenser;
“pharmaceutical technician” means person enrolled under section 24 of the
Act;
“pharmaceutical assistant” means a person enlisted under section 28 of the
Act;
“medical practitioner” has the same meaning ascribed to it under the Medical
Practitioners and Dentists Act;
Cap. 152
“medicines dispenser” means a person who has undergone at least one year
training course in pharmaceutical sciences from a recognized
academic institution and approved by the Council;
Cap. 298 “public servant” has the same meaning ascribed to it under the Public Service
Act;
“ward health committee” means the committee of a respective ward of local
government authority associated with health related matters;
Cap. 113 “peri – urban” has the same meaning ascribed to it under the Land Act.

PART II
ADMINISTRATIVE PROVISIONS

Objectives of 4. An Outlet shall be accredited for the purpose of :

operating Outlets (a)enhancing access to safe, good quality and efficacious medicines
to the rural and peri-urban populations;
(b) ensuring that medicines are affordable to the rural and peri-urban
populations;
(c)ensuring easy monitoring and control distribution of medicines;
(d) ensuring that adequate medicines information and services are
provided to the public

Establishment 5.-(1) For the better carrying out the objectives stipulated under
and composition regulation 4, the Council Food and Drugs Committees, also known by
of CFDC acronym “CFDC”, established under the Tanzania Food, Drugs and
Cosmetics (Delegation of Powers and Functions) Regulations, 2015 shall,
GN No. 476 of
2015 subject to sub regulation (2), have mandates to perform functions and
discharge duties stipulated under these Regulations.
(2) Notwithstanding any provisions of the Tanzania Food, Drugs
and Cosmetics (Delegation of Powers and Functions) Regulations, 2015, the
Council Food and Drugs Committee shall be composed of the following
GN No. 476 of
members:
2015
(a) District Executive Director who shall be the Chairman;
(b) District Medical Officer who shall be Secretary;
(c) District Pharmacist who shall be a coordinator;
(d) District Health Officer;
(e) District Trade Officer;
(f) District Legal Officer;
(g) District Treasurer;
(h) a representative of ADDO owners.
(3)The Committee may, for the purpose of exercising its mandate

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under these Regulations, co-opt any person to its meetings as the Committee
may consider necessary.
(4)Subject to regulation 6, the Committee shall, for the purpose of
these Regulations, oversee the management and operations of Outlets within
the local authority area in which such Committee situates.
(5) The District pharmacist shall be responsible for coordinating all
activities vested in the Committee in the respective District.

Function of the 6. The Committee shall be responsible for -

Committee
(a) performing functions stipulated under the First Schedule to the
Tanzania Food, Drugs and Cosmetics (Delegation of Powers
GN No. 476 of and Functions) Regulations, 2015;
2015
(b) advising the Council on all matters relating to personnel,
operations, and premises management, and in particular it
shall:
(i) evaluate and recommend applications for approval;
(ii) recommend for revocation of permits issued pursuant
to the Act;
(c) conducting supervision and inspection in Outlets;
(d) preparation and submission of quarterly reports to the Council
and copy thereof to the Regional Food and Drug Committee;
(e) taking action in response to inspection from Ward Health
Committee;
(f) advising the Council on matters pertaining to enforcement of the
Act;
(g) renewal of ADDO business permits;
(h) handling complaints from the lower levels;
(i) carrying out such other functions as may be assigned to it by the
Council;
(j) collection of fees and charges prescribed pursuant to these
Regulations on behalf of the Council.

Vesting mandate 7.-(1) A Ward Health Committee shall discharge duties stipulated
to Ward Health under regulation 16, and any other duties assigned to it pursuant to these
Committee Regulations.
(2) In discharging its duties, the Ward Health Committee may, co-opt a
pharmaceutical personnel or medicines dispenser of the respective ward.
(3) A Ward Health Committee shall prepare and submit quarterly
reports to the Ward Development Committee and the CFDC.

PART III
ACCREDITATION OF OUTLETS

Restriction for 8.-(1) A person shall not operate, sell or dispense medicinal
operation of products in any premises for which these Regulations relate except in
Outlet premises accredited and issued with a valid business permit in accordance
with these Regulations.
(2) A person who contravenes this regulation commits an offence.

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Application for 9.-(1) A person who wishes to operate an Outlet shall, apply for
Accreditation accreditation by filling in the application form provided under First Schedule
of these Regulations upon payment of prescribed fees.
(2) Without prejudice to sub-regulation (1), an applicant shall, after
filling in the application form, submit the duly completed application form to
the Village Executive Officer of the village or street in which the prospective
Outlet situates who shall review, recommend and submit the forms to the
Ward Executive Officer.
(3) The Ward Executive Officer shall, upon receipt of the
application form and recommendations of the Village Executive Officer, and
within the earliest possible time, convene the Ward Health Committee with a
view to decide on the application.
(4) In deciding the application, the Ward Executive Committee-
(a) may-
(i) make a site inspection of the prospective Outlet
location, for the purpose of collecting necessary
information and making recommendations thereof;
(ii) interview the applicant and proposed dispenser;
(iii) request for evidence of qualifications for the
proposed dispenser;
(iv) undertake preliminary inspection of the premises;
and
(v) prepare brief report using inspection checklist
approved by the Council on their preliminary
findings of inspection of premises;
(b) shall consider-
(i) applicant’s citizenship;
(ii) applicant’s attitude and behavior;
(iii) residential address;
(iv) the need for the service in the community;
(v) past and current business activities carried out by that
applicant; and
(vi) location and physical address of the proposed premises.
(5) A Ward Health Committee shall not carry out inspection for
the purpose of either refusing or approval of the application forms submitted.
(6) The application forms and report including the
recommendations of the Ward Health Committee shall be submitted to the
CFDC.
(7) The undertaking of the Ward Health Committee and
submission of its report to the CFDC shall not take longer than twenty eight
days from the date of receipt of completed application.
(8) Upon receiving the applications, the CFDC shall conduct
physical inspection of premises for verification and compliance of premises
and personnel as specified in these Regulations.

Scrutinization of 10.-(1) The District Pharmacist shall compile all applications

applications received, prior to submission to the Committee for consideration.
(2) Upon receipt of compiled report, the Committee shall scrutinize
the applications by previewing all application forms and attachment including
inspection report and copy of contract between the owner and dispenser.
(3) The Committee may, at any reasonable time, require the

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applicant to furnish to it any additional information as it may consider

appropriate.

Submission of 11.-(1) The Committee shall, at least on quarterly basis, discuss all
report and applications from the area of its jurisdiction, and prepare a report of
recommendation applications and submit the recommended list of applicants to the Council for
to Council
approval.
(2) The Committee shall forward to the Regional Administrative
Secretary a copy of the report prepared in terms of sub regulation (1).

Determination of 12. -(1) The Council shall, not later than twenty one days from
recommendation date of receipt of the report, determine the recommendations issued to it in
terms of regulation 11.
(2) In making determination the, Council may approve or
disapprove the recommendations,
Provided that, where the Council has disapproved the
recommendations of the CFDC, the Council shall provide reasons for the
disapproval.
(3) The determination under sub-regulation (2) shall be
communicated to the respective Committee which shall notify the respective
applicant accordingly.
(4) An applicant whose application has been approved by the
Council shall, upon receipt of approval notification, pay to the Council, the
prescribed fee.

Accreditation 13.-(1) The Council shall, upon receipt of proof of payment of

and issuance of accreditation fee, issue a non transferable Outlet Certificate of Accreditation
permit and Business Permit as prescribed in the Second Schedule.
(2) Every permit issued by the Council to the Outlet shall expire on
30th of June every year, and may be renewed subject to the fulfillment of the
provisions of these Regulations.
(3) A person whose business permit is due to expire shall, at least
three months before the expiry of the permit, apply to the CFDC for renewal
of the permit as prescribed in the First Schedule.

Re-accreditation 14.-(1) Notwithstanding the requirements provided under

of Outlet regulation 13 (2), an accredited Outlet shall be re-accredited after every three
years, upon maintaining requirements as prescribed in these Regulations.
(2) Subject to the provisions of sub section 27 (4) of the Act, the
Council shall have the power to approve or disapprove applications for re-
accreditation depending on prevailing circumstances.
(3) An applicant for re-accreditation shall be required to pay re
accreditation fee which shall be equal to the accreditation fee.

Allocation and 15.-(1) For the better carrying out of the functions of the
distribution of Committee, all monies derived from payment of fees under these Regulations
funds to shall be allocated and distributed to each Committee as the Council shall
Committee
determine.
(2) In determining an amount to be allocated to each Committee,
the Council shall consider activities plan and amount collected by each
Committee.

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Conditions of 16. A person duly permitted to operate an Outlet shall at all times-
operation of
Outlets
(a)observe the standards, conduct and ethics of operation of Outlets
as prescribed under these Regulations;
(b) comply with the good dispensing practice and relevant
guidelines of a registered premises.

Revocation and 17.-(1) The Registrar shall, upon satisfaction that a holder of
cancellation of dispensing certificate, accreditation certificate or business permit is operating
certificates and an Outlet, in contravention to these Regulations or any other written law,
permits
cancel or revoke the dispensing certificates, accreditation and business
permit, as the case may be.
(2) Notwithstanding sub-regulation (1), the Registrar, shall by
notice remove or cancel from the register the name of any person or premises
on the grounds that the person-
(a)has failed to comply with any provision of these Regulations or
any other written law;
(b) has not fulfilled conditions to be recognized as ADDO
dispenser;
(c)has requested that his name be removed from the register, in
which case, such person shall be required to lodge with the
Registrar an affidavit to the effect that no disciplinary or
criminal proceedings are being or are likely to be taken against
him;
(d) has failed to pay to the Council, within six months as from the
date on which it became due for payment, any prescribed fee;
(e)is dead,
(f) is found unfit to practice;
(g) has been declared bankrupt by a competent court of law;
(h) has been convicted by a competent court of law of a criminal
offence with serving sentence of more than one year; or
(i)has failed to furnish the Registrar, within a period of two months
with such information as the Registrar may require in terms of
these Regulations.
(3) Notice of removal, under of sub regulation (2), shall be given
by the Registrar in writing to the person concerned through the address of that
person as appearing in the register, and such person shall, from the date on
which notice has so been given, cease to practice as dispenser or owner of an
Outlet or perform any act which he was entitled to perform under these
Regulations; and any permit or certificate issued to him shall be deemed to
have been cancelled.
(4) Any person who is aggrieved by the decision of Council under
this regulation may, within twenty eight days from the date of receipt of
decision of the Council, appeal to the Minister.

Surrender of 18. A person whose certificate or business permit is suspended or

certificates and cancelled from the register shall, within twenty eight days, be required to
permits surrender to the Registrar, his certificate, business permit and any other
documents bearing identification or ownership of the Council.

Restoration of 19. Where a certificate or permit of an Outlet is suspended in terms

name to the of these Regulations, the Registrar may restore the ADDO to the register if
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register the permit holder-

(a)applies in the prescribed form for such restoration;
(b) complies with, or remedies any matter that rendered his
suspension;
(c)pays the prescribed fee in respect of such restoration; and
(d) complies with such other requirements as the Council may
determine.

PART IV
STANDARDS OF OPERATION OF OUTLETS

(a) Personnel

Qualification of 20.-(1) A person shall qualify to be a dispenser of medicines at an

Dispenser at Outlet if the person-
Outlet
(a) is recognized by the Council as pharmaceutical personnel other
than a registered pharmacist; or
(b) qualifies to practice as:
(i) trained nurse;
(ii) enrolled nurse;
(iii) clinical officer;
(iv) assistant clinical officer;
(v) assistant medical officer;
(vi)medical officer; or
(vii) community health worker
(2) Without prejudice to sub-regulation (1), a public servant
shall not qualify to practice as dispenser of medicine at an Outlet.

Dispensers 21.-(1) Except for pharmaceutical personnel, persons referred to

Training Course under regulation 23(1) (b) shall be required to complete the Dispenser
Training Course approved by the Council.
(2) The Dispenser Training Course shall be conducted for a period
of not less than five weeks.
(3) The content of the Dispenser Training Course shall be
determined by the Council after taking into account the applicant’s minimum
qualification.
(4) A dispenser of medicine at an Outlet shall, upon successful
completion of the Dispenser Training Course, be awarded a Dispensing
Certificate as prescribed in the Seventh Schedule

Services to be 22. Save as otherwise provided in the Act, the services to be

provided at an provided at an Outlet shall include:
Outlet
(a)the purchasing, acquiring, keeping, possessing, using, supplying
or selling of any general sale medicines, OTC medicines and
ADDO prescription only medicines;
(b) taking care of the medicine related needs of clients, including-
(i) determining the indication, safety and effectiveness of
therapy;
(ii) furnishing of relevant information and advice to any

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person with regard to medicine;

(iii) determining client’s compliance to the therapy and
follow-up to ensure that the client’s needs are being
met;
(c)nutritional and food supplements, sanitary toiletries, hygienic
products, cosmetics; and
(d) any other health services or acts as may be approved by the
Council.

Categories of 23.-(1) Save as otherwise provided for in these Regulations, a

ADDO person shall not dispense medicines at an Outlet unless that person is
dispensers categorized as such pursuant to these Regulations or is, in any case, approved
by the Council.
(2) The dispensation of medicines at an Outlet may be performed
by any of the following categories of persons:
(a) Outlet dispenser;
(b) medicines dispenser;
(c) pharmaceutical technician; or
(d) pharmaceutical assistant.

Conduct of 24.-(1) A dispenser of medicines at an Outlet shall-

ADDO (a) at all times of service:
Dispensers (i)maintain a high standard of personal hygiene;
(ii) wear a prescribed attire;
(iii)wear an identification badge which bares his photo and
that identifies him as a dispenser authorized to practice at
the respective Outlet or at such other premises as the
Council may approve;
(iv) not dispense or issue prescription drugs without
prescription;
(v)not work under the influence of alcohol or illicit medicines;
and
(vi) conduct himself in an appropriate and orderly behavior.
(b) ensure that the original copy of his dispensing certificate is
displayed at a conspicuous place of the Outlet premises; and
(c) be accountable and answerable for all activities conducted at
the respective Outlet.
(2) A person who contravenes the provision of this regulation
commits an offence and shall be liable, on conviction, to-
(a) in the case of an offence under sub regulation (1)(a)(ii), a fine
of fifty thousand shillings;
(b) in the case of an offence under sub regulation (1)(a)(iv), a fine
of one million shillings;
(c) in the case of an offence under sub regulation (1)(a)(vi) or
(1)(b), a fine of one hundred thousand shillings.

Contract between 25.-(1) The owner of an Outlet shall enter into a contract with
owner and dispenser of medicines, specifying the terms and conditions of employment
ADDO dispenser as prescribed under the Third Schedule to these Regulations.
(2) A copy of the contract stipulated under sub-regulation (1), shall
form part of the application for certificate and permit documents as prescribed
in these Regulations, and a copy thereof shall be deposited with the
Committee.
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(3) Every contract shall comply with the respective employment laws.
(4) Without prejudice to freedom of parties to contract, a contract
specified under sub regulation (1) shall not provide for terms or conditions
that impede a dispenser of medicines at an Outlet to practice in accordance
with the requirement of these Regulations.

ADDO owner’s 26.-(1) Save as otherwise provided in these Regulations, a person

requirements shall not own an Outlet unless the person-
(a) is a Tanzanian adult who is mentally fit;
(b) has attended ADDO awareness course;
(c) has no record of violation of any law;
(d) has no criminal record.
(2) Every owner of Outlet shall:
(a)ensure that operation procedures are in conformity with these
Regulations;
(b) have valid business permit and certificate of accreditation which
shall be conspicuously displayed at the Outlet premises;
(c)attend ADDO owners awareness programme organized or
coordinated by the Council for that purpose;
(d) ensure that he has a certified copy of the Outlet dispenser
certificate issued by the Council;
(e)ensure that, at all times of operation, the dispensation of
medicines at the ADDO premises is only conducted by a
person permitted to dispense medicines in terms of regulation
27 of these Regulations;
(f) promptly notify the Committee when the Outlet is permanently
closed.
(3) The Committee shall, upon receipt of the information provided under
sub-regulation (2)(f), inspect the inventory and advise on the appropriate
disposal of medicines or any item in the inventory.
(4) A person who contravenes the provision of this regulation commits
an offence and shall, on conviction, be liable to-
(a)in the case of an offence under sub regulation (2)(b), a fine of
one hundred thousand shillings;
(b) in the case of an offence under sub regulation (2)(e), a fine of
one million shillings;

Occurrence of 27. An ADDO owner or such other authorized personnel shall, in

theft the event of an occurrence of theft or such similar incident occasioning loss of
medicines at an Outlet, report the incident at a nearest police station and
notify the Committee or Council thereof.

Awareness 28.-(1) Every owner of an Outlet shall attend awareness program

program for formulated and approved by the Council.
ADDO owners
(2) Upon completion of the program referred to under this
regulation, an Outlet owner shall be awarded a certificate of attendance by the
Registrar or any other person authorized by the Registrar:
Provided that, the certificate of attendance shall be issued upon
payment of the prescribed awareness program fee.

Continuing 29.-(1) An Outlet dispenser shall attend and complete annual

education for continuing education prescribed by the Council.
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ADDO dispenser
(2) The continuing education program referred to under sub
regulation (1) shall be an added advantage in the determination of renewal or
grant of permit.

(b) Location and premises requirements

Location of 30.-(1) An Outlet shall be exclusively established in rural and peri-urban

ADDO premises areas as determined by a local government authority.
(2) Every Outlet shall be located at a distance of not less than 500 metres in
radius from pharmacy, 150 metres in radius from an Outlet in peri-urban areas, and 100
metres in radius from Outlet in rural areas, and such distances may be determined or
varied depending on the population of a particular area or any other factor as may be
determined by the Council.
(3) Notwithstanding sub regulation (2), in case where the pharmacy is
established at a distance less than 500 meters from an existing ADDO premises, a
notice of two years shall be given to ADDO owner to upgrade his services.
(4) A person wishing to carry on a business of an Outlet shall, when
applying for accreditation, clearly state the location and address of his premises in the
application.
(5) The Council may, basing on local demand and need for pharmaceutical
service, direct an applicant for an Outlet to locate his business in other appropriate
locations so as to reduce unnecessary congestion and provide services to underserved
community.
(6) Subject to sub regulation (5), an applicant who is not satisfied with
decision of the Council may, within twenty one days from the date of receipt of the
decision, appeal to the Minister.

Design and 31.-(1) Every owner of an Outlet shall, for the purpose of registration, ensure
description of that such Outlet-
ADDO Premises
(a) is durable and strong;
(b) is roofed with materials which shall make it free form leakages;
(c) is well protected from entry of rodents, birds, vermin and pets;
(d) has adequate space to carry out primary functions of storage,
dispensation and sale of pharmaceutical products as follows:
(i) in the case of prescription only medicines, storage shall be in
an exclusive area of the Outlet;
(ii) non-prescription medicines may be displayed in the
dispensing area;
(e) is designed in a manner in which:
(i) doors and windows are well secured to prevent theft and
unauthorized entry; and
(ii) a minimum of two rooms, one for dispensing and the other one
for storage, whereby the dispensing room has at least 4 meters by
4 meters and height of 2.5 meters, while the store room has at
least half size of the dispensing room with shelves and adequate
aeration;
(f)has surface with smooth finishing that can be cleaned with disinfectants;
(g)has sufficient space separate to allow for counseling of patients within the
confines of the premises;
(h)has space within which ADDO prescription medicines shall be
conspicuously displayed;
(i) has rooms that are painted with washable white colour;
(j) has adequate supply of clean and safe water, and includes having in place
a hand washing sink; and
(k) is in compliance with general hygiene standards in terms of the
surroundings and outer space of the premises.
(2) The premises shall have the following descriptions:

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(a) standard logo in the design set out under the Fourth Schedule to these
Regulations, and which shall be issued to an applicant upon payment
of the prescribed fee to the Council;
(b)as a minimum requirement, the name of the Outlet to be clearly displayed
on the front part of the premises; and
(c) “NO SMOKING” sign conspicuously placed to prohibit smoking in the
premises.
(3) An ADDO owner or any other responsible person shall, at all times of
operation of ADDO business, ensure the ADDO premises are maintained within the
standards and requirements under sub regulation (1).
(4) A person who contravenes any provisions of this regulation commits an
offence and shall, on conviction, be liable to a fine of two hundred thousand shillings.

Products for 32.-(1) Every Outlet shall stock authorized pharmaceutical products as
dispensation at stipulated under the Tanzania Food Drug and Cosmetic (Scheduling of Medicines)
ADDO Regulations 2015.
GN NO. 63 of
2015
(2)All pharmaceutical products for sale at an Outlet shall be registered in
accordance with laws applicable for registration of medicines.
(3) The pharmaceutical products referred to under sub-regulation (2) shall be
procured from a registered wholesaler or manufacturer.
(4) All pharmaceutical products held in inventory shall be stored in the
manufacturer’s original packaging and properly labeled with the manufacturer’s original
label.
(5) A person who contravenes any provisions of this regulation, commits an
offence and shall, on conviction, be liable to a fine of one million shillings.

Removal of 33.-(1) A person shall not-.

labels and
repackaging
(a) remove labels from containers of any pharmaceutical product;
(b) repack and re-label pharmaceutical products not for the purpose of
immediate dispensing to the patients.
(2) Any person who contravenes any of the provisions under sub-regulation
(1) commits an offence and shall be dealt with in accordance to the provisions of the
Cap.219 Tanzania Food, Drugs and Cosmetics Act or Regulations made under it.

Dispensation of 34.-(1) An Outlet dispenser shall only dispense pharmaceutical products

registered registered in accordance with laws applicable for dispensation of medicines.
pharmaceutical (2) Every Outlet dispenser shall ensure that:
products
(a) all necessary instructions and advice for proper use and care of the
product is given to patient;
(b)ADDO prescription only medicines are dispensed against a prescription;
(c) records of all Outlet prescription only medicines dispensed by him is
maintained in register approved by the Council; and
(d)no medicine is dispensed unless in accordance with medicines dispensing
guidelines or any other written law.

(c) Record keeping and documentation

Invoices, receipts 35.-(1) All invoices and receipts for non-prescription medicines and
and ledger book permitted prescription medicines shall be stored in the premises in an easily retrievable
file for not less than five years.
(2) Save as provided in sub-regulation (1), the retrievable file, preferably a
ledger book shall contain-
(a)name of supplier of prescription and non prescription medicines;
(b) amount of medicines received and issued for dispensing; and

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GN. NO. 185 (contd)

(c)balance remained in stock.

(3) A person who contravenes the provision of sub regulation (1) commits
an offence and shall, on conviction, be liable to a fine of seven hundred thousand
shillings.

Dispensing 36.-(1) An Outlet dispenser shall maintain permitted prescriptions and non
Register prescription medicines in a Dispensing Register prescribed in the Fifth Schedule of
these Regulations, and the register shall be used in recording and storing information of
the patient in relation to the dispensed medicines.
(2) Save as provided in sub-regulation (1),the recorded information shall
include-
(a) name and full address of the patient, including age and sex;
(b)diagnosed diseases;
(c) generic name and where applicable, trade name of the medicines
dispensed;
(d)dose, dosage and quantity of medicines dispensed;
(e) name of the health facility such as dispensary where the patient was
attended; and
(f)signature of the dispenser.
(3) The dispensing register shall be kept within the premises for not less
than five years.
(4) The Council may require any owner of an Outlet to submit to the
Council, records contained in the dispensing register.
(5) A person who contravenes the provision of this regulation commits an
offence and shall, on conviction, be liable to a fine of seven hundred thousand shillings.

Register for 37.-(1) There shall be a register for expired products which shall be kept and
expired products maintained by the dispenser of medicines at an Outlet.
(2) The dispenser of medicines shall seal, quarantine and label the expired
products with the following red ink descriptive words “Expired Medicines – Not for
Sale”.
(3) The owner of an Outlet shall, on quarterly basis, submit the list of all
expired products to the Committee.
GN No. 314 of (4) Disposal of expired medicines shall be dealt with in accordance with
2015 Tanzania Food Medicines and Cosmetics (Handling and Disposal of Unfit Products)
Regulations), 2015.
(5) A person who contravenes the provision of sub paragraph (1) commits
an offence and shall, on conviction, be liable to a fine of seven hundred thousand
shillings.

(d) Wholesaler Obligation

Obligation of 38.-(1) A wholesaler shall not sell registered medicines to an Outlet unless
wholesalers the wholesaler is registered by the Council in accordance with the Act.
(2) The wholesaler referred to under sub-regulation (1), shall be the
distributor of registered “over the counter medicines” and “ADDO prescription only
medicines”.
(3) The wholesalers shall sell medicines and ADDO prescription only
medicine to the Outlet as stipulated in the Tanzania Food Medicines and Cosmetics
GN No 315 of (Scheduling of Medicines) Regulations), 2015.
2015
(4) A wholesaler shall be responsible for verifying credentials of an Outlet
prior to the sale of medicines.
(5) A wholesaler who sells prescription medicines to Outlets shall keep
records and invoices related to sale of all medicines.
(6) A wholesaler who-
(a) sells ADDO prescription medicines to non-accredited dispensing outlet; or
(b) sells to an Outlet any medicines other than medicines referred to in these
Regulations,

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commits an offence.

Establishment of 39. There shall be ADDO restricted wholesale shops to be established within
ADDO local authorities for purposes of selling ADDO medicines on wholesale basis as
Restricted provided under these Regulations.
wholesale

Registration and 40.-(1)The procedure for registration of pharmacy, and issuance of permit
permit for for wholesale pharmacy under the Act shall apply mutatis mutandis to the registration
ADDO and issuance of permit to ADDO Restricted Wholesaler.
Restricted
Wholesale
(2)Notwithstanding sub-regulation (1), the Council shall not issue ADDO
Restricted Wholesale permit to a District Council that owns a wholesale pharmacy.

Responsibilities 41.-(1) An ADDO Restricted Wholesaler shall be supervised by a

of ADDO pharmaceutical technician.
Restricted
Wholesale
(2) The ADDO Restricted wholesaler shall in addition to general sales
medicines be permitted to stock or sell ADDO prescription only medicines.
(3) Notwithstanding the provisions of sub-regulation (2), it shall be the
duty of the ADDO Restricted Wholesale supervisor to verify permits of the Outlet or
licensed health care facilities prior to the sale of any prescription only medicines.
(4) Every ADDO Restricted Wholesale shall be required to maintain a
register for the purchase, sale and dispensing of all medicines.
(5) An ADDO Restricted Wholesaler who sells general sales medicines
and prescription only medicines to Outlets or licensed health care facilities shall:
(a) maintain a separate register for the sale of prescription medicines; and
(b)provide to the client an invoice or receipt listing all medicines sold.
(6) An ADDO Restricted Wholesaler who sells any medicines to non-
registered medicine dispensing outlet commits an offence.

PART V
INSPECTION AND SUPERVISION

(a) Supervision levels

Mandate of 42. Subject to the provisions of this Part, the mandate of supervision of
supervision Outlet shall vest in the following organs:
(a) in the case of supervision at ward level, the Ward Health Committee;
(b)in the case of supervision at district level, the Council Health
Management Team; and
(c) in the case of supervision at regional level, the Regional Health
Management Team.

Inspection at 43.-(1) A Ward Health Committee shall be responsible for conducting

Ward level inspections and monitoring of Outlets at ward level.
(2) A ward inspector shall report the outcome of inspection to the Ward
Health Committee.
(3) The Ward Health Committee shall, at least on quarterly basis, submit its
inspection reports to the Council Food and Drugs Committee.
(4) The Ward Health Committee shall take actions against any violations of
these Regulations within its mandate and report any other issues beyond its jurisdiction
to the Council Food and Drugs Committee.

Inspection at 44. The Council Food and Drugs Committee shall-

district level (a) as a minimum requirement, conduct quarterly inspection of all Outlet
premises.
(b)receive and review all inspection reports from Ward Health Committee,

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and;
(c) carry out further inspection in cases where the it determines that the
report from the Ward Health Committee raises a cause for concern for
which an inspection is required.

Inspection at 45.-(1) The Regional Health Management Team, shall undertake monitoring
regional level and supervisory inspection responsibility over Outlets within its jurisdiction.
(2) The Regional Health Management Team may, where necessary, carry
out audit inspection of Outlets and make recommendations to Committee and Council
(3) The Regional Health Management Team shall have the right to inquire
into any steps taken by the Committee as described in its quarterly summary reports.

Inspection at 46.-(1) The Council shall be responsible for inspection and monitoring at
national level the national level.
(2) The Council may carry out audit inspections in respect of any premises
which provide pharmaceutical services.
(3) The Council or its official representative shall have a right to access all
Outlets’ inspection reports for information, advice, and recommendation or to re-
address over any drug outlet malfunctions.

(b) Inspectors of Outlet

Appointment of 47.-(1) The Council shall appoint inspectors to conduct inspection for the
inspectors purpose of these Regulations.
(2) Without prejudice to sub regulation (1), the following persons are hereby
appointed as inspectors of their respective locality or jurisdiction:
(a) in the case of inspection at regional level, the Regional Medical Officer,
Regional Pharmacist and Regional Health Officer;
(b) in the case of inspection at district level, District Medical Officer,
District Pharmacists and District Health Officer;
(c) in the case of inspection at ward level, in-charge of a government health
centre or dispensary and ward health officer,; and
(d) any other person appointed by the Council for that purpose.
(3) Inspectors appointed by the Council shall be provided with special
inspectors training course that will be conducted by the Council or any other agency
approved by the Council.
(4) Inspectors appointed under these Regulations shall be issued with the
Council inspector’s identity card and inspection checklists.
(5) All Outlet inspectors appointed under these Regulations shall report to
the Council.

Complaints 48. Any complaint or accusation against an inspector’s findings made by an

against outlet owner or medicine dispenser shall be directed to the relevant inspection personnel
inspection at a hierarchy inspection levels referred to in these Regulations.

Determination of 49.-(1) When dealing with complaints from the respective inspection level,
complaints an institution responsible for the particular inspection level shall act upon within two
weeks on such accusations or complaints lodged within its mandate.
(2) All complaints which are not resolved at the particular inspection level
shall be referred to the institution responsible for inspection at a higher level for
appropriate action.

Powers of the 50.-(1) The Council shall have powers to revoke the appointment of an
Council in inspector where it is satisfied that the inspector has contravened any of the provisions of
relation to the Act or these Regulations.
inspectors
(2) Decision of the Council under sub-regulation (1) shall be the final.
(3) All the powers of inspection vested to a person shall cease immediately

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after the revocation of appointment as inspector or the termination of employment of

such person in the public service.

Declaration of 51. An inspector shall, before accepting an appointment, make a declaration

interest of interest using a declaration form specified under the Sixth Schedule to these
Regulations

Conduct of 52.-(1) All inspections shall be conducted in team of at least two inspectors.
inspection
(2) Routine inspection shall be conducted-
(a) at least quarterly in the case of inspection at ward level;
(b)biannually in the case of inspection at Committee level; and
(c) in the case of inspection at Regional or Council level, at any time as the
Regional Committee or Council may consider necessary.
(3) An inspector shall, in the course of a conduct of inspection at an Outlet-
(a) wear an official identification card during the whole process of inspection,
(b)introduce and inform the owner or Outlet dispenser the purposes of the
inspection; and
(c) register himself in the visitors register book.
(4) Upon completion of inspection, an inspector shall write all required
information in the inspection forms, and the inspector and owner or dispenser shall sign
therein, and a copy shall remain with the owner or dispenser as proof of inspection.
(5) Upon completion of inspection, the inspector shall prepare an inspection
report, copies of which shall be submitted to the inspectors’ immediate supervisory
body or respective authorities.

Quarterly reports 53.-(1) Every inspector shall prepare a quarterly inspection report and
submit to the Committee through the respective Ward Health Committee.
(2) The Committee shall, during its scheduled meeting, deliberate on the
reports, and may take action on the report or direct a Ward Health sub Committee to
take any appropriate action in terms of these Regulations.
(3) The Committee shall submit copies of minutes and summary reports to
the Regional Administrative Secretary and the Council.

Inspection 54. An Outlet may, for the purpose of this Part, be supervised by an
supervision and appointed health authority, peer supervisor or any other person identified by the Council
monitoring for that purpose.

PART VI
OUTLET ETHICS AND CONDUCT

Construction of 55. Save as otherwise provided in these Regulations, the provisions under
Code of Ethics this Part shall generally constitute ethics and conduct for which every ADDO owner,
and Conduct dispenser of medicines shall respectively comply with.

Honest and 56. Every Outlet owner and dispenser shall in the course of discharging
integrity their duties, act with honesty and integrity.

Duty of care to 57.-(1) Outlet service providers shall exercise the duty of care in a
patients compassionate manner.
(2)In determining the requirement under sub- regulation (1), the health well
being of a patient shall be the core concern of the Outlet service provider, and in that
regard, the person providing service shall ensure that the needs of a patient are afforded
the first priority.

Special relation 58. Outlet service providers shall-

with patients (a) maintain an ethical patient-service provider fiduciary relationship;
(b)uphold moral obligations in return for the trust bestowed to them by the
community;

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(c) respect the autonomy, individuality and dignity of each patient, and avert
from any form of discrimination;
(d)acknowledge the right of the patient to self-determination and individual
self worth by encouraging patients to participate in decisions related to
their health; and
(e) respect personal, cultural and religious differences.

Confidentiality 59. Every dispenser of medicines at an Outlet shall maintain confidentiality of

patients’ information acquired in the course of practice, dealings or conduct, and shall
not disclose the information given except with the authorization of the patient or
requirement of the law.

Restrictions to 60.-(1) A dispenser of medicines at an Outlet shall-

DLDM (a) not dispense, promote or distribute medicines or provide such related
dispensers on services which are not of good quality;
quality of (b)not in any way undertake clinical or laboratory services to patients or
services prescribe prescription medicines, except that he may offer limited
patient advisory activities and counseling;
(c) preserve medicines that require preservation in refrigerator, cooling
system or fan where applicable, and in any case, preserve medicines
according to good pharmacy practice (GPP) as may be prescribed by
the Council in the applicable guidelines;
(d)not participate in any promotional methods or campaigns which
encourage the irrational use of medicines; or
(e) not undermine the role played by other health care providers.
(2) A person who contravenes the provision of this regulation commits an
offence and shall, on conviction, be liable to a fine of not less than two hundred
thousand shillings but not exceeding one million shillings.

Collaboration 61. Outlet dispensers shall collaborate with other health care providers to
with other health achieve the best possible outcome that ensures patients understand the role of other
care providers health care providers.

Competence 62. A dispenser of medicines at an Outlet shall be responsible for ensuring

building by the improvement of personal competence, and shall strive for excellence and continuous
ADDO improvement of the quality of service and care he provides.
dispensers

Health 63.A dispenser of medicines atanOutlet shall, at all times of service to

promotion individuals, community and society as a whole, advocate for health promotion,
including the promotion of the use of cost effective therapies and rational use of
medicine.

Restriction on 64.-(1) A relationship for commercial gain between a health care practitioner
commercial and Outlet dispenser or owner which renders an unreasonable cost of medicines to, or is
relationship in any way, detrimental to the beneficiary of Outlet services is, for the purposes of these
Regulations, prohibited.
(2) A person who contravenes the provisions of sub-regulation (1) commits
an offence and shall, on conviction, be liable to a fine of five hundred thousand
shillings.

Breach of code 65. A person who contravenes any provision in this Part commits a breach
of ethics and of the Code of Ethics and Conduct, and the breach shall be dealt with as professional
conduct misconduct in the manner and procedure prescribed under the Act and these
Regulations.

PART VII

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GN. NO. 185 (contd)

GENERAL PROVISIONS
Compounding 66.-(1) Notwithstanding the provision of these Regulations relating to
of offences penalties, where a person admits in writing that he has commited an offence under
these Regulations, the Registrar may, at any time prior to the comencement of the
hearing by a court of competent jurisdiction, compound such offence and order such
person to pay sum of money, not exceeding one half of the amount of the fine to which
such person would otherwise have been liable to pay if he had been convicted of such
offence.
(2) Where an offence is compounded in accordance with sub regulation (1)
and proceeding are brought against the offender for the same offence, it shall be a good
defence for the offender to prove to the satisfaction of the court that the offence with
which the offender is charged has been compounded under sub regulation (1).
(3) Where the person fails to comply with the order issued under this
regulation within the prescibed period, the Registrar-
(a) shall, in addition to the sum ordered, require the person to pay an interest at the
rate prescribed in Nineth Schedule of these Regulations; and
(b) may enforce the order in the same manner as a decree of a court for the
payment of the amount stated in the order.
(4) The list of offences prescribed in the Eighth Schedule shall be the
offences compoundable under these Regulations.

Fee and Charges 67.-(1) All fees, charges, levies chargeable in terms of these Regulations
shall be fees, charges, levies due to the Council, and shall be as prescribed in the Ninth
Schedule of these Regulations
(2) The fees and other charges payable under these Regulations shall be
utilized as its funds for defraying expenses incurred in connection with the performance
of its function as per the provisions of the Act.
(3) The fee and charges payable under these Regulations shall neither be
refundable nor transferable.

Offences and 68.- (1) Any person who-

penalties (a) upon being requested lawful entry by an inspector or officer executing his
duties under these Regulations fails to give or refuses access to any
inspector or officer;
(b)obstructs or hinders an inspector or officer from the execution of duties
under these Regulations;
(c) fails or refuses to give information that he may lawfully be required to
give to an inspector or officer execution of duties under these
Regulations;
(d)gives to the inspector or officer false or misleading information knowing
it to be false or misleading; or
(e) abates or aides the commission of the offence,
commits an offence and is liable, upon conviction, to a fine of not less than five hundred
thousand shillings or imprisonment for a period not exceeding six months or to both.
(2) A person who contravenes any provisions of these Regulations for which no
other penalty has been prescribed, commits an offence and is liable on conviction to
a fine of not less than one million shillings or to imprisonment for a term of not less
than six months or both such fine and imprisonment.

Revocation and 69.-(1) The Tanzania Food, Medicines and Cosmetics (Standards and Code
savings of GN. of Ethics for Accredited Drugs Dispensing Outlet) Regulations, 2004 and the Food,
358 of 2004 and Drugs and Cosmetics (Standards and Code of Ethics for Accredited Drugs Dispensing
GN 19 of 2009 Outlet) (Amendment) Regulations, 2009 is hereby revoked.
(2) Notwithstanding the revocation under sub regulation (1), any license,
certificate, permit and administrative order, directions or instructions made or given or
issued under or in pursuance of the provisions of the revoked Regulations, shall be
deemed to have been made, issued, directed or issued under or in pursuance of the
provisions of these Regulations, and shall remain in force until revoked, replaced or
rescinded by any subsidiary legislation , license, permit, directions, administrative

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GN. NO. 185 (contd)

Regulations or instructions lawfully given under these Regulations.

_________

FIRST SCHEDULE
_________

(Made under regulations 9(1) and 13(3))

WIZARA YA AFYA, MAENDELEO YA JAMII, JINSIA, WAZEE NA WATOTO

BARAZA LA FAMASI

FOMU YA MAOMBI YA KIBALI CHA KUANZISHA BIASHARA YA DUKA LA DAWA

MUHIMU

SEHEMU A: IJAZWE NA MWOMBAJI

1. Jina la mwombaji………………………………......................................................................
Anuani kamili……………...........Umri..............Jinsia(ME).......(KE)......... Simu....................
2.Jina la duka……………………………………..……………………………...........................
3.Eneo ambalo duka lipo :
Mkoa………………..Wilaya…………Kata……………..……Kijiji/Mtaa………………..
4.Jina kamili la Mtoa Dawa…..…........... Anuani.... Simu……...Namba ya usajili……ya
tarehe……..……

Tarehe ya maombi………………………………………...Saini ya Mwombaji ………………..

Angalizo:
i) Watoa dawa waliosajiliwa na Baraza la Famasi tu ndio watakaoruhusiwa kusimamia
biashara ya DLDM
ii) Nakala ya vyeti vya mtoa/watoa dawa na mikataba iliyosainiwa viambatanishwe na ombi
hili.

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SEHEMU B: IJAZWE NA AFISA MTENDAJI WA KIJIJI (OMBI LA KIJIJINI)

AU MTAA (OMBI LA MJINI) WA ENEO HUSIKA.

1. Jina la mwombaji……………Uraia wa Mwombaji……….

2. Tabia ya mwombaji katika jamii anayoishi………………

3. Taarifa fupi ya mwenendo wa mwombaji katika biashara yoyote aliyowahi kuwa nayo siku
za nyuma au sasa katika kata hii ……….……………………………
4. Mahitaji ya huduma ya biashara ya dawa kutoka kwa wananchi katika eneo: mwombaji
aeleza kama wananchi katika eneo hilo wanahitaji huduma hii akitaja sababu
………………………………………………………………
5. Mapendekezo/Maoni kuhusu ombi hili
……………………………………………………………………

Tarehe ya kupokelewa ombi……………Tarehe ombi liliposhughulikiwa ………

………………………………………….……………………
Jina, Saini na Muhuri wa VEO au MEO

Angalizo:
(i) Baada ya kupokea na kujaza sehemu husika, VEO/MEO awasilishe fomu hii kwa WEO
ambaye ataiwasilisha kwa wakaguzi wa kata.
(ii) VEO au MEO haruhusiwi kukataa au kutolea maamuzi ombi lolote.

SEHEMU C: IJAZWE NA WAKAGUZI WA KATA

Ijazwe kulingana na mahitaji ya The Pharmacy (Duka la Dawa Muhimu) (Standards and Ethics
for Dispensation of Medicines) Regulations, 2017

1. Tarehe ya kupokelewa kwa ombi na nyaraka za mwombaji kutoka kwa VEO au MEO
(Zingatia Sehemu A na B hapo juu)………………….................................
2. Tarehe ya kumhoji Mwombaji na Mtoa Dawa mtarajiwa kulingana na taarifa kutoka Sehemu
A na Sehemu B ………………………………….................................
3. Matokeo ya mahojiano……………...............................................
4. Eleza usahihi wa nyaraka na taarifa zilizoambatanishwa..............................
Tarehe ya ukaguzi wa jengo……………………………...

5. Usahihi wa eneo linapofunguliwa Duka la Dawa Muhimu kulingana na vigezo vilivyowekwa

na Baraza la Famasi…………………………………………………….

6.Mapendekezo/Maoni ya Wakaguzi wa Kata kwenda kwenye Kamati ya Chakula na Dawa ya

Halmashauri (CFDC)…………………………………….…………………

7. Majina na saini za wakaguzi

Jina……………………………………………………..
saini…………………….......………...
Jina……………………………………………………..
saini…………………….......…….…..
Jina……………………………………………………..
saini…………………….......…….…..

8. Tarehe ya Afisa Mtendaji Kata alipopeleka mapendekezo au maoni kwenda kwenye Kamati
ya Chakula na Dawa ya Halmashauri ( CFDC)………………………
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GN. NO. 185 (contd)

………………………………….……...................
Jina, Saini na Muhuri wa Afisa Mtendaji Kata

Angalizo:
i) Wakaguzi wa Kata, na Afisa Mtendaji wa Kata haziruhusiwi kukataa ombi au kulitolea
maamuzi ya mwisho ombi lolote, badala yake wapeleke mapendekezo au maoni ya
maamuzi ya kikao husika (Kamati ya Chakula na Dawa ya Halmashauri-CFDC).
ii) Ukaguzi ufanyike kwa kutumia Dodoso la ukaguzi la PC na ripoti kuambatanishwa
kwenda CFDC
iii) Kwa DLDM linalofunguliwa eneo la mjini: Umbali kati ya duka moja na jingine lisiwe
chini ya mita 300 kila upande
iv) kwa maeneo ya miji midogo: Umbali kati ya duka moja na jingine lisiwe chini mita 200
kwa maeneo ya vijijini.
v) Umbali kati ya DLDM na duka la dawa moto lisiwe chini ya mita 500.

SEHEMU D: IJAZWE NA KAMATI YA CHAKULA NA DAWA YA HALMASHAURI

(CFDC)
Ijazwe kulingana na mahitaji ya The Pharmacy (Duka la Dawa Muhimu) (Standards and Ethics
for Dispensation of Medicines) Regulations, 2017

1. Tarehe ya kupokelewa kwa ombi husika kutoka kwa Mtendaji wa Kata.....………………

2. Tarehe ya kikao cha CFDC kujadili maombi ya DLDM …………………………………
3. Maoni ya CFDC kutokana na ukaguzi wa eneo husika pamoja na nyaraka zilizowasilishwa
(Jaza iwapo CFDC ilibidi kufanya ukaguzi tena)
……………………………………………………………………………

4. Maamuzi ya CFDC kuhusu ombi la kufungua DLDM………………………………

5. Masharti yoyote aliyopewa mwombaji ambayo anapaswa kuyatimiza kabla ya kupewa kibali
(i)………………………………………………………………………….
(ii) …………………………………………………………………………
(iii)………………………………………………………………………….

…………………..………………………….
Jina, Saini na Muhuri wa Katibu, CFDC

……………..……………………………………..
Jina, Saini na Muhuri wa Mwenyekiti, CFDC

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WIZARA YA AFYA, MAENDELEO YA JAMII, JINSIA, WAZEE NA WATOTO

BARAZA LA FAMASI

FOMU YA MAOMBI YA KUHUISHA (RENEW) KIBALI CHA DUKA LA DAWA

MUHIMU

Mwenyekiti,
Kamati ya Chakula na Dawa ya Halmashauri(CFDC)
…………………………………………..…………

SEHEMU A: IJAZWE NA MWOMBAJI

1. Jina la mwombaji…………………………
2. Anuani kamili…………………………Namba ya simu …………
3. Jengo la biashara ya Duka la Dawa Muhimu (DLDM) lipo katika
a. Nyumba/ Ploti Na:……………………………...………………….……
b. Kitongoji / Mtaa/kijijii………………...………………………….….……
c. Kata…………………………………………………………...…………
d. Tarafa…………………………..…………………………………
e. Wilaya ya…………………………………………………………
f. Mkoa……………………………………………………
4. Jina la Duka la Dawa Muhimu ……………
5. Namba ya kibali (Accreditation Certificate No.)…………
6. Biashara hii itasimamiwa na Watoa Dawa waliosajiliwa na Baraza la Famasi wafuatao:-
(i) Jina kamili la Mtoa Dawa ….…...................Anuani…..........................simu …
Namba ya cheti cha utoaji dawa (Dispensing Certificate) …..cha tarehe..............

(ii) Jina kamili la Mtoa Dawa.............……Anuani……...simu ……………...

Namba ya cheti cha utoaji dawa (Dispensing Certificate) …………cha tarehe …......

Tarehe ya Maombi……………………. Saini ya Mwombaji……………………..

Kumbuka:
Ambatanisha (1) Nakala ya vyeti vya Watoa Dawa, (2) Mkataba wa makubaliano kati ya
mmiliki na mtoa dawa
(3) Barua halisi za Watoa Dawa kukubali kuendelea kusimamia DLDM

…………………………….……..…………
Jina, Saini na Muhuri wa Katibu, CFDC

…………………………………………………..
Jina, Saini na Muhuri wa Mwenyekiti, CFDC

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

__________

SECOND SCHEDULE
__________

(Made under regulation 13(1))

MINISTRY OF HEALTH, COMMUNITY DEVELOPMENT, GENDER, ELDERLY AND

CHILDREN
PHARMACY COUNCIL

CERTIFICATE OF ACCREDITATION
This is to certify that the Premises named........................ owned by M/s..........which is located
at..................Village/Street...........Ward..........................District/Municipality in....................
Region has complied with the requirements of the said Regulations and is hereby granted Facility
Identification Number (FIN).................. of.........................
_________________ ____________________________________
DATE OF ISSUE SIGNATURE OF REGISTRAR AND STAMP

SUBJECT TO THE FOLLOWING CONDITIONS:-

1. The premises and the manner in which the business is to be conducted must conform to
the requirements of the Pharmacy Act of 2011 or any other written law related to the
Registration of premises at all times, failing of which this certificate shall be suspended
or revoked.
2. Any change in the ownership, name and location of the registered premises shall be
approved by the Council.
3. This certificate is not transferable to other premises or to any other person
4. This certificate shall be displayed conspicuously in the registered premises.
5. The Owner of the business is required to obtain the business permit annually from the
his/her respective CFDC

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

MINISTRY OF HEALTH, COMMUNITY DEVELOPMENT, GENDER, ELDERLY AND

CHILDREN
PHARMACY COUNCIL

DLDM BUSINESS PERMIT

Permit is hereby granted to M/S............of.................to carry the business of Outlet at the Premises
situated at ……..Street, in.................. Ward, .................in..........Region to sell over the counter
drugs and a limited number of prescription drugs as provided in the Tanzania Food, Drug and
Cosmetic (Scheduling of Medicines) Regulations, 2015after being issued with the Facility
Identification Number (FIN)…………from the Council

The following person(s) is/are hereby authorised to become dispenser(s) of this

premises in accordance with provisions of these Regulations…………………

This permit shall have and continue to have effect from and including the day when it is issued
until it ceases to have effect on ………………..

Issued on …………. Fees Tshs............................

________________________________
DATE: _______ SIGNATURE OF REGISTRAR AND STAMP

CONDITIONS:
i. This Permit does not authorize the holder to operate the business in unregistered premises
or during the period of suspension, revocation or cancellation of accreditation of the
premises in respect of which it was issued.
ii. This Permit is not transferable without a written approval of the Council.
iii. This Permit shall be displayed conspicuously in the registered premises.
iv. Any change including change of dispenser(s) of the registered premises shall be approved by
the Council

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

____________

THIRD SCHEDULE
_____________

(Made under regulation 25(1))

MKATABA WA KUENDESHA DUKA LA DAWA MUHIMU

MAKUBALIANO haya yamefanyika leo tarehe…………….Mwezi…………. Mwaka………

KATI YA
……………………………………………………. wa S.L.P ………………………………
(ambaye kwa mujibu wa mkataba huu ataitwa MMILIKI) kwa upande mmoja,
NA
…………………………………………….(ambaye kwa mujibu wa mkataba huu ataitwa MTOA
DAWA”) kwa upande wa pili.
KWA KUWA MMILIKI anaridhia kuendesha biashara ya Duka la Dawa Muhimu kwa mujibu
wa aya ya 32(1) ya The Pharmacy (Duka la Dawa Muhimu) (Standards and Ethics for
Dispensation of Medicines) Regulations, 2017
KWA KUWA uendeshaji wa maduka haya unahitaji MTOA DAWA wa Duka la Dawa Muhimu
kwa mujibu wa sheria; na
KWA KUWA MMILIKI anaridhia kuweka mtaalamu MTOA DAWA katika kuendehsa na
kusimamia uuzaji wa dawa muhimu;
KWA PAMOJA MMILIKI na MTOA DAWA wanakubaliana kuendesha biashara ya duka la
dawa Muhimu kwa maelezo na masharti yafuatayo: -
1. Baada ya kukamilika kuwekwa sahihi katika makubaliano haya MMILIKI atakuwa ndiye
mmiliki wa Duka la Dawa Muhimu na MTOA DAWA atakuwa ndiye mtoa dawa katika
duka liitwalo …………………………….lilipo wilaya ya ……………... kata ya
…………………. kijiji/mtaa ……………….
2. MMILIKI atamlipa MTOA DAWA mshahara na marupurupu kama ilivyofafanuliwa katika
kifungu cha nne cha makubaliano haya.
3. MTOA DAWA atatakiwa kutii maadili ya utoaji wa dawa, kukidhi na kutunza dawa kwa
kiwango kinachokubaliwa kwa mujibu wa Kanuni za Maduka ya Dawa Muhimu za mwaka
2017.
4. MMILIKI atatakiwa kuchukua hatua muhimu kuanzisha duka na kusimamia uuzaji dawa
zilizothibitishwa kuwa ni dawa zinazoruhusiwa kuuzwa katika duka la dawa muhimu tu.
Hatua hizo muhimu ni pamoja na kufuatilia na kupatiwa leseni, kibali au idhini kutoka
BARAZA LA FAMASI na utunzaji wa DUKA LA DAWA MUHIMU katika hali ya
inayokubalika kwa mujibu wa sheria.
5. Mmiliki atafanya malipo kwa ajili ya kukidhi mahitaji yafuatayo katika uendeshaji wa
DUKA LA DAWA MUHIMU;
a) Mshahara na marupurupu kwa MTOA DAWA shilingi ……………….. kwa kila mwezi
kwa kipindi chote cha mkataba huu au vinginevyo watakavyokubaliana kubadili kiwango
hicho kwa ajili ya utekelezaji wamajukumu yake kama ilivyo katika Kifungu cha 2 cha
mkataba huu;
b) Gharama zote kwa ajili ya marekebisho au ukarabati wa DUKA LA DAWA MUHIMU
c) Maswala yote ya kitaalamu yatakuwa chini ya usimamizi na uangalizi wa MTOA
DAWA;
d) Kwa mujimu wa mkataba huu maswala ya kitaalamu ni pamoja na kutoa dawa, kuhifadhi
dawa, kutunza kumbukumbu za dawa na utunzaji wa eneo la DUKA LA DAWA
MUHIMU.

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

6. Mkataba huu utadumu kwa kipindi cha miezi kumi na miwili (12) na endapo Mmiliki na
Mtoa Dawa wataridhia wanaweza kuurejea kwa kila mwaka isipokuwa tu pale ambapo
sehemu moja ya mkataba huu itaonyesha nia ya kukatisha mkataba kwa taarifa ya maandishi
itakayotolewa na upande huo kwa kipindi kisichopungua miezi mitatu (3)
7. Inapotokea kuwakuwa upande mmoja umeonyesha nia ya kukatisha mkataba na kutoa taarifa
kwa upande mwingine kwa kipindi kisichopungua miezi mitatu (3), nakala ya taarifa hiyo
lazima ipelekwe CFDC.
8. Mmiliki atatoa gharama zote za utengenezaji wa mkataba huu.
9. Bila kuathiri kilichoandikwa katika mkataba, Kamati ya Wilaya ya Dawa itatunza na
kuhifadhi nakala ya mkataba itakayopelekwa kwake na MMILIKI.
KWA USHAHIDI WA PAMOJA MMILIKI na MTOA DAWA wnakubaliana na kuweka
sahihi zao katika mkataba huu kwa tarehe na jinsi ulivyoandaliwa kama ifuatavyo:
Umesainiwa na kutolewa
Leo tarehe …………………….......................…. {…. ……………………..}
Sahihi ya Mmiliki
Na Mmiliki (jina) …………………………...... {…. ……………………..}
Sahihi ya Mmiliki
Mbele ya (Jina la Shahidi) ……………………………… {…. ……………………..}
Sahihi ya Shahidi
Umesainiwa na kutolewa
Leo tarehe……………………................................ .{........................................}
Sahihi ya Mtoa Dawa
Na mtoa dawa (jina) ………………….........
Mbele ya (Jina la Shahidi) ……… {…. ……………………..}
Saini ya Shahidi

Angalizo: Mkataba huu ni sampuli. Mmiliki na mtoa dawa wanaweza kuuboresha ili kukidhi
mahitaji yao

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

____________

FOURTH SCHEDULE
_____________

(Made under regulation 31(2)(a) )

MINISTRY OF HEALTH, COMMUNITY DEVELOPMENT, GENDER, ELDERLY AND

CHILDREN

PHARMACY COUNCIL

___________

STANDARD LOGO FOR OUTLET

___________

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

____________

FIFTH SCHEDULE
____________

(Made under regulation 36(1))

MINISTRY OF HEALTH, COMMUNITY DEVELOPMENT, GENDER, ELDERLY AND

CHILDREN

PHARMACY COUNCIL

DISPENSING REGISTER

Name of dispenser……………………………………… Date………………………

Serial No……………………
Patient name: …………………………………….Sex M/F………………………..
Patient address:
Diagnosed disease
Name of medicines dispensed (Generic/Trade)
Dose & Dosage
Quantity Dispensed
Name of Health Facilities (dispensary or health centre)
Remarks e.g. ADR Reported etc

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

___________

SIXTH SCHEDULE
___________

(Made under regulation 51))

MINISTRY OF HEALTH, COMMUNITY DEVELOPMENT, GENDER, ELDERLY AND

CHILDREN

PHARMACY COUNCIL

DECLARATION FORM BY LOCAL INSPECTORS OF OUTLET AND ANY OTHER

MEDICINES OUTLETS
___________

1.First Name………………………………………….Last name…………

2.Address…………………………………………………..
3.Name: Hamlet/Village/mtaa………………………………………
Ward…………………………………………
District……………………………………….
4.Current position held in local government…………………
5.Do you own or hold share in any pharmaceuticals business (Yes/No) ………... if yes, state:
Name of the Business………………………
Hamlet/street/village…………….
Ward………………………………………………
District……………………………………………..
6.Does anyone in your family own or hold share in pharmaceutical business within your ward?
(Yes/No)……………. If yes give details on the following
Name of the Business………………………..
Location Hamlet/street/village…………………………
Ward………………………………………..………………..
District……………………………..……………
Have you in past had any pharmaceutical business? No/Yes. If Yes state why you abandoned
the business……
7.I,……………..hereby declare that the information have provided here under is true and correct
to the best of my knowledge, I also know that if eventually it is proved by the Council that
the information I have given it false, fictitious or fraudulent or based on inadequately verified
information, may result in appropriate, legal action by the Council.
8.Signature……………………….. Date………………………………………

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

_______

SEVENTH SCHEDULE
_______

(Made under regulation 21(4))

THE UNITED REPUBLIC OF TANZANIA

No XXXXX

Passport size

MINISTRY OF HEALTH, COMMUNITY DEVELOPMENT, GENDER, ELDERLY AND

CHILDREN
Pharmacy Council Tanzania

DISPENSING CERTIFICATE

This certificate is awarded to

...........................................................................
Who has attended and passed a special pharmaceutical dispensing course
For Accredited Drugs Dispensing Outlets (Duka la Dawa Muhimu)

Held at......................................from...................to..........................

..............................
Registrar-Pharmacy Council
Date ..........................

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

________
EIGHTH SCHEDULE
_____

(Made under regulation 66(4))

LIST OF COMPOUNDED OFFENCES

S/No. List of Compounded Offences Contrary to Paragraph

1. Non displaying of registration certificate by ADDO 24(b)
dispenser
2. Dispensing or Issuing prescription drugs without 24(a)(iv)
prescription
3. Non displaying of other registration certificates(e.g. of 26(1)(b)
a ADDO, etc)
4. Inappropriate and disorderly behavior by dispenser 24(a)(vi)
5. A dispenser not wearing the prescribed attire 24(a)(ii)
6. Poor sanitation and hygiene of premises 31(1)(k) &31(3)
7. Poor record keeping (lack of registers for purchase, 34(2)(b), 38, 39(1) & 37(1)
delivery, dispensing, prescription book or any other
prescribed register)
8. None preservation of medicines in a premises without 60(c)
running refrigerator, cooling system, or fan where
applicable contrary to good pharmacy practice
9. ADDO premises not meeting standards, i.e not having 31
adequate supply of clean and safe water, and includes
having in place a hand washing sink
10. Allowing the dispensation of medicines by a person 20
who is not a categorized person or person approved by
the Council
11. ADDO dispenser conducting clinical or laboratory 60(b)
services
12. Stocking unauthorized medicines 32(1)
13. Unethical commercial relationship for gain by ADDO 64(1)
Dispenser or owner

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 Pharmacy (Accredited Drugs Dispensing Outlets) (Standards and Ethics for
Dispensation of Medicines)
GN. NO. 185 (contd)

__________

NINTH SCHEDULE
__________

(Made under regulation 66(3)(a))

LIST OF FEES AND CHARGES

ITEM FEES/CHARGES
1.0 Registration
1.1 Outlet Premises 60,000/=
1.2 Outlet Dispenser 20,000/=
1.3 ADDO Restricted Wholesale 250,000/=

2.0 Annual Renewal Fees

2.1 DLDM Business Permit 40,000/=
2.2 Retention for ADDO Dispensers 10,000/=
2.3 ADDO Restricted Wholesale Business Permit 100,000/=

3.0 Restoration Fees

3.1 Restoration of ADDO dispenser 200,000/=
3.2 Restoration of ADDO Premises 300,000/=

4.0 Other Fees and Charges

4.1 Issuance of a duplicates (Course, Permit, 50,000/=
Accreditation or Dispensing certificate extracts etc)

4.2 Application for Change of Premises 90,000/=

4.3 Application for Change of Name/Ownership 50,000/=
4.4 Issuance of ADDO Premises Logo 10,000/=
4.5 Inspection of ADDO Restricted Wholesale 100,000/=

4.6 Authentification of document (certificate etc) 10,000/=

4.7 Penalty for delays 25%

Dodoma, UMMY MWALIMU

26th February, 2019 Minister for Health, Community
Development, Gender, Elderly and Children

35