LAWS AND ETHICS ORAL EXAMS
SESSION 3 ONLY
1. (a)Mention Sections in the Acts relating to Registration and Licensing of Premises for Pharmacy Business
ANSWER(a)The following are sections that
relate to registration of premises for pharmacy business:
ii. Section 36 of the pharmacy act 2011 states the application of permit
ANSWER
i. Section 18, Pharmacy Practice
Regulations 2012, states conditions for establishment and operation of a
pharmacy
ii. Section 20, Pharmacy Practice
Regulations 2012, states application for pharmacy registration
iii. Section 21, Pharmacy Practice
Regulations 2012, states registration of a pharmacy
iv. Section 27, Pharmacy Practice
Regulations 2012, states categories of registers.
2.
Section 34 of
the Pharmacy Act 2011stipulates requirements for Registration of premises
dealing in pharmaceutical businesses as prerequisite. The legislation prohibits the use of any
premises for dispense, sale, sell, supply or storage of pharmaceuticals unless
the premises has been registered by the Pharmacy Council for that purpose. This
section states the following:
ANSWER
·
A person shall not sell, dispense or
supply medicinal products except in premises registered under this Act.
·
An application for registration or renewal
of registration of premises shall be made to the Council in the prescribed
form, and shall be accompanied by such fee as the Council may prescribe.
·
The Registrar or any person in his behalf
shall-
o
keep a register of all premises registered
under this section;
o
register premises if he is satisfied that
the requirements to be complied with by the applicant as prescribed by the
Council from time to time have been complied with; or
o
have powers to approve the location and
name of the proposed premises.
·
The Council may, for good cause, refuse to
register or cause to be removed from the register, any premises which is or has
become unsuitable for purposes for which they were registered.
·
A person who contravenes the provisions of
subsection (1) commits an offence and upon conviction shall be liable to a fine
not exceeding ten million shillings or imprisonment for a term not exceeding
two years or to both.
3.
Describe
section 36 of the pharmacy act no 1 of 2011
ANSWER
o A person
shall not sell, dispense or supply medicinal products unless he has obtained a
permit issued under this Act.
o An
application for a permit shall be made to the Council in the prescribed form,
and shall be accompanied by such fee as the Minister may prescribe.
o The
Council shall not issue a permit to sell medicines and related medical supplies
under this section unless the Council is satisfied
§ that the premises in respect of which the application relates shall be stored, meets the prescribed standards;
§ that the equipment are available for storing the medicines and related medical supplies;
§ with the suitability of the equipment and facilities which are used for distributing the medicines and related medical supplies; and
§ with the arrangements made or to be made for securing the safe keeping, and the maintenance of adequate records in respect of medicines and related medical supplies stored in or distributed from those premises.
o A separate
permit under this section shall be required in respect of each set of premises
in which the business is carried on
4.
Section 18 of the pharmacy practice regulations 2012
states the conditions for establishment and operation of a pharmacy: Enumerate
the requirements?
ANSWER
o A person
shall not establish and operate a business of a pharmacist unless the premise
is registered in accordance with the Act.
o A premise
registered under these regulations shall be required to comply with the good
pharmacy practice and registration guidelines of a business of a pharmacist
o There
shall be a separate application and registration of each premises intended for
use as pharmacy as shall be prescribed by the council in the registration
guidelines.
o Each
registered premises for establishment of a pharmacy shall be issued with a
registration certificate which is non-transferable.
5.
Section 20 of the Pharmacy (Pharmacy Practice)
regulations, 2012 prescribes terms and conditions that must be adhered during
the application for the registration and permits. Describe
ANSWER
Any person
requiring to operate a business of a pharmacist under these regulations shall
be required to submit a duly completed application form to the Registrar
accompanied:
§ A copy of
any lease agreement, sub-lease agreement or other agreement in terms of which
the applicant has the right to occupy the proposed pharmacy premises;
§ If the
owner of the premises, submit a certified copy of the title deed or similar
document evidencing his right to ownership of such premises;
§ A copy of
site plan of the roof and floor plan of the building, if applicable, indicating
the location of the pharmacy premises in relation to adjoining or surrounding
businesses and access to and from such premises a copy of the plan layout of
the actual pharmacy premises;
§ In case
the applicant is a partnership, a copy of the partnership agreement, stating
the name of the pharmacist designated to accept responsibility for the duties
as superintendent as prescribed under these Regulations;
§ An
application fee prescribed by the Council; and
§ Any other
information as may be requested by the Council.
o The notwithstanding
the provisions of these Regulations, every application made under these
regulations shall be required to comply with all the requirements prescribed by
the Council in the registration guidelines and good pharmacy practice of a
business of a pharmacist.
o The
Council shall inspect or cause an inspection of the proposed pharmacy premises,
if found to satisfy with the requirements, the application shall be accepted,
if found unsuitable, the application shall be deferred or rejected with reasons
in writing.
6. Mention categories of registers
ANSWER
i.
Community pharmacy;
ii.
Wholesale pharmacy;
iii.
Institutional pharmacy;
iv.
Consultant pharmacy;
v.
Manufacturing pharmacy; and
vi.
Any other premises registered under the Act
7.
Describe any (ten) 10 requirements for premise
to be registered specifically on premise design?
ANSWER
·
Premise design
requirements?
i.
The premises shall be durable, safe and made of
permanent building materials so as to protect pharmaceuticals from potential
harmful influences.
ii.
The premises shall be roofed with corrugated iron
sheets, concrete slabs or tiles and shall have the floor minimally made up of
terrazzo, tiles or any other hard washable surfaces.
iii.
The premises shall be designed and equipped so as to
provide protection against rodents, birds, vermin or any destructives insects
or animals.
iv.
The rooms shall be painted with white/creamy
washable paint with smooth washable finishing.
v.
The surrounding should be maintained so as to
minimise dust, soil and other contamination to enter the building.
vi.
Sufficient lighting and ventilation shall be
provided to enable all operation to be carried out.
vii.
Premises should be sufficiently secured to prevent
theft and unauthorised entry and a “NO SMOKING” sign should be conspicuously
displayed at the entrance.
viii.
The premises shall be provided with suitable
equipment and facilities for proper storage, safety keeping and handling of
pharmaceuticals.
ix.
In retail outlets where compounding of
extemporaneous preparations is taking place there shall be availability of
simple dispensing equipment like balances, mortar and pestle, measuring
cylinder and a sink in the dispensing area.
x.
In Premises providing human and veterinary
Medicines, separate displaying shelves and storage cabinets shall be provided
for each category.
xi.
Premises dealing with pharmaceutical products shall
not stock in the same registered premises chemicals or pesticides used
exclusively for plant protections.
xii.
Premises shall have separate secured cabinets with
lock and key for keeping controlled Medicines (Schedule I medicines).
xiii.
Approval of storeroom located within the pharmacy or
warehouse at mezzanine or underground shall be subject to adherence to other
premises requirements including provision of sufficient light, air conditioning
facilities
8. Describe requirements for
premise to be registrations specifically on premise layout Retail pharmacy
premises
ANSWER
·
Retail
Pharmacy must have a minimum of three rooms with clear demarcation and linked
to each other for displaying, dispensing and storerooms. The premises must have
one main secured entrance and where applicable an emergency rear door.
·
The minimum
total size/ area of the premises shall at least measure 25 m2. The
rooms should have not less than 2.5m internal heights.
·
The rooms
should be equipped as indicated in the inspection checklist with adequate
shelves or pallets as the case may be for proper display and storage of
medicines respectively.
·
For the retail
pharmacies that plan to offer other services approved by the Council, shall get
approval from Council, must have extra separate rooms and must comply with
standards stipulated for the provision of such services.
9. Enumerates requirements for
premise to be registrations specifically on premise layout of Distribution
(Wholesale) Premises
ANSWER
·
Wholesale pharmacy
shall have not less than three rooms with clear demarcation and linked to each
other for display, receiving and dispatch, record keeping and storage. The
premises must have one main secured entrance.
·
The premises
shall have a minimum total size/ area of at least 40m2. The rooms
should have not less than 2.5m internal heights.
·
The rooms
should be equipped with adequate shelves and pallets for proper display and
storage of medicines as indicated in the inspection checklist.
10. Describe requirements for
premise to be registrations specifically on premise layout Retail and
Distribution (Wholesale) Premises
ANSWER
·
Premises for
both retail and wholesale business are professionally not encouraged. These
premises shall be given permit depending on circumstances
·
Premises for
both retail and wholesale business shall have at least three rooms namely;
display, receiving and dispatch room; sales, record keeping and dispensing
room; and the storage room.
·
The minimum
total size/ area of the premises shall at least measure 60m2. The rooms should
have not less than 2.5 m internal height with clear demarcation/partition for
retail and wholesale business.
·
The rooms
should be equipped as indicated in the inspection checklist with adequate
shelves and pallets for proper display and storage of medicines respectively.
·
A clear
demarcation of wholesale receiving/dispatch area from the retail part shall be
provided to allow orderly receipt/dispatch of pharmaceuticals in bulk.
·
There should
be a separate entrance doors for retail and wholesale business.
11.
Requirements
for Licensing of Premises for Pharmacy Business
A.
……T……..Every
premise registration certificate shall expire on the 30th June after every
three from the date of registration.
B.
…..F……
Applicants shall be required to fill and submit business permits application three
(3) months before 30th July
C.
…F….. Every
premise registration certificate shall expire after the 30th June after every
three from the date of registration.
D.
…F….
Applications for registration of premise and business permits should be done three
(3) months after 30th June.
E.
….T…. Permit
is only valid for one year and will be renewed yearly
12.
Premises
registration certificate shall remain valid provided that the following
conditions are met.
ANSWER
i.
Premises start
to operate within six (6) months following the approval or registration
ii.
Three (3)
years from date of issuing have not elapsed
iii.
Business
permit is renewed yearly.
iv.
The premises
have been maintained and remained in conditions which led to its initial
registration
v.
There is no
change of business name, ownership or location
13.
Enumerates
Procedures for Application for Approval of Location, Registration of Premises
and Permits prior to operate the Business of Pharmacy.
ANSWER
The following procedures
shall be adhered by applicants;-
·
Shall apply
for the approval of location to the Registrar, through zonal coordinators,
respective Regional Pharmacist (RP) and District Pharmacist (DP).
·
Application
for the approval of location of the premises shall be made in a prescribed
approval of location form.
·
The
Application form shall be obtained from Pharmacy Council office, zonal
coordinators or through RP and DP offices of the respective Regions and
Districts or through the Pharmacy Council Website www.pctz.or.tz
·
Applicant
shall be required to fill in completely and accurately all the required
information in the approval of location form.
14.
An applicant
shall be required to fill in completely and accurately all the required
information in the approval of location form. On submission the form must be
accompanied must be accompanied with? Mentions
ANSWER
i.
With a payment
receipt of fees as prescribed under The Pharmacy (Fees and Charges)
Regulations, 2012.
ii.
Copy of the
site plan of the building indicating the location of the pharmacy premises in
relation to adjoining or surrounding businesses and access to and from the
premises’
iii.
Copy of the
professionally drawn floor plan indicating the actual layout of the pharmacy
premises drawn to scale with exact measurements.
15. Application for
the registration of the premise and business permits (Sections 36 of the
Pharmacy Act and 19 and 20 of the Pharmacy (Pharmacy Practice) regulations,
2012).Forms must be filled in completely and accurately with all the required information.
On submission the forms must be accompanied with. Mention?
§ With a payment receipt of
fees as prescribed under The Pharmacy (Fees and Charges) Regulations, 2012.
§ A certified copy of the
contract agreement between two parties (Proprietor and Superintendent)
§ A copy of registration
certificate of the superintendent issued by Council
§ A letter of commitment from
the superintendent to supervise the said premise
§ Copies of certificate of
other pharmaceutical personnel planned to work in the pharmacy and their
certified contract agreements.
§ A copy of registration
certificate of names/business/ corporate from relevant authorities (BRELA).
§ A copy of lease or sub-lease agreement or any document evidencing his
right to ownership of the premise
16. Enumerates Inspection
procedure of new premises
ANSWER
·
Upon receipt of the duly filled approval of location
form, inspectors will visit the said area/premise for first inspection
·
The inspector or any other public officer authorized
by the Council shall make sure that the premises applied for registration is
inspected to verify if all the requirements have been met
·
The inspectors shall use the inspection checklist
when conducting the inspection of new pharmacy premises and give their
observations and recommendation on the suitability of the premises.
·
If the premise/area failed to comply with the
required standards, applicant will be informed immediately during inspection in
writings, either to address short falls or to look for another
location/premise.
·
The applicant after first inspection report, if
allowed may continue with process of construction/renovation of the premises.
Shall do so in six (6) months and upon completion shall inform the
registrar/regional/district pharmacist for final inspection within prescribed.
·
In case an applicant fails to inform the Council
within 6 months for final inspection, the Council will cancel/refute the report
and declares for any interested person(s) to use the said area for the same
business
·
The applicant after a successful final inspection
report shall apply for registration of premise and for the permit to operate
business of a pharmacist.
17. Describe
procedure for Registration of new premises:
ANSWER
·
Upon receipt of duly filled of all forms necessary
for application, premises inspection report and all other necessary documents
from the inspectors, the officer authorized by the Registrar shall scrutinise
all the documents and if satisfied that all the requirements have been met,
shall compile and give its recommendations to the Committee responsible for
registration of premises for consideration.
·
If the premises registration or licensing
requirements have not been met, the applicant will be informed accordingly to
address the shortfalls before reconsideration.
·
The Council may register, withhold, reject or
register with conditions any application by providing reason(s) for his/her
decisions.
·
All applicants, whose applications have been
approved, approved with condition, withhold or rejected as the case may be, shall
be informed in writing’s on the status of their application.
·
Before starting the business, approved applicants
will be required to purchase all necessary material necessary for the operation
of the pharmacy i.e. Logo, reference materials, dispensing coats etc.
·
The Registrar shall then issue the Premises
Registration Certificate and the respective permits, which allow the applicant
to start carrying out the business of a pharmacy.
