Download 03 Parmaceutical licensing. Retail trade

Department of Management and Economics of
Pharmacy
LICENSING IN PHARMACY.
Special requirements
In retail trade remedies:
Lecturer Assoc. prof. M.V. Leleka
The practice of pharmacy within
each state is regulated by the
laws of the state, deluding the
regulation of licensure for
pharmacy practice.
Licensing is foreseen in Ukraine
for the government control. The
aim of licensing and standards
is to protect public health by
ensuring that medicines and
medical devices meet definable
standards of quality assurance
and are manufactured in
conditions that are clean and
free of contaminants.
Functions of pharmacy are: making of
medicines on individual prescriptions and
the clinic requirements (production
function}; realization of medicines on
recipes and without them (trading function);
organization of sanitary-informative activity
among the population, pharmaceutical care
and informative aid to the hospitals on
pharmaceutical questions (informative
function); providing of the first medical aid
and the aid for the privilege category of
population (social function).
The Structure of the Chemist Shop
One can see several departments in chemists shop. They are:
1.
2.
3.
4.
prescription department,
non-prescription department,
ready-made drugs department,
drugs store department.
A prescription department is the department for reception of
prescriptions and delivery of drags. At this department
medicines are sold or made according to prescriptions. There
one may buy powders and pills, mixtures and ointment,
tinctures and decoctina as well as drops, suppositories ets.
At the non-prescription department one can see ready-made
drugs, different things for medical care and medical herbs.
If the chemists is large it has ready-made drugs department
where the ready-made drugs are sold under the prescriptions.
Classification of the pharmacy
Pharmacy may be:
1. On a functional index pharmacies are divided into
productions, which are engaged in the medicine making on
the individual recipes of doctors and unproductive, carrying
out exceptional realization of industrial production medicine.
2. On a form the management and to the sources of financing
distinguish: self-supporting, which independently form profits
as difference between the cost of realization and purchase
cost of commodity; the state budget pharmacies belonging to
the organizational clinic structure and is financed directly from
the state budget.
3. In obedience to territorial subordination city and rural
pharmacies are determined.
4. To directions of activity of pharmacy distribute on: retail,
which carry out only the retail medicine realization, and
hospital, interhospital, self-supporting, the state budget
pharmacies, which serve hospital, nursery schools, schools,
sanatoriums and other organizations and enterprises, on the
cashless form of calculation. Hospital and interhospital
pharmacies are named abroad „hospital pharmacies".
5. On the medicine assortment, realized to the users,
pharmacies are divided into homoeopathic, preparations of
vegetable origin, hormonal preparations, ready made drug,
general type - pharmacy, in the assortment of which
preparations of different pharmaceutical firms and
pharmacotherapeutical groups.
6. According to the owner State and communal, private and
with the collective pattern of ownership
7. In obedience to the groups of patients and categories of
population, which are mainly served by pharmacies, the
specialized pharmacies are determined, for example,
geriatrics, „Mother and child" and general type.
To practice pharmacy in any state, a pharmacist
must become a registered pharmacist (RPh), also
known as a licensed pharmacist.
Pharmacists are licensed by the State Board of
Pharmacy. Requirements vary somewhat from state
to state, but in general, to be licensed a pharmacist
must:
• Graduate from an accredited college of
pharmacy
• Participate in residency or internship programs
to acquire direct, "hands-on" patient care experience
«
Pass a rigorous examination, known as the NABPLEX
(National Association of Boards of Pharmacy Licensing
Examination) : The pharmacist's educational experience does
not end upon being licensed.; Most states require licensed
pharmacists to take continuing education courses every year in
order to maintain their licenses to practice. Pharmacists obtain
this additional education through correspondence courses,
attending professional meetings and seminars presented by
pharmacy associations, or participating in courses provided by
the
schools
and
colleges
of
pharmacy.
*| Licensing of the Pharmaceutical Activities of Pharmacy
Establishments
By law, subject to licensing:
•production;
•wholesale drugs;
• retail trade in drugs.
1.11. The facade of the building, where the pharmacies,
according to its intended to be a sign indicating the names
of institutions ("Pharmaceutical composition (base),
Pharmacy, "Drugstore", "Pharmaceutical stand") that is not
considered advertising. Near the entrance to the pharmacy
school located in a prominent place information about the
entity and the owner or authorized body, work
pharmaceutical establishment. For pharmacies and their
divisions are legally required information indicating the next
address (hours) and the nearest pharmacy. Not in the
locations of structural units Pharmacies put the sign
"Pharmacy on the pharmacy - Pharmacy staff and other
information does not match the information specified in the
license, in including as advertising.
If desired, the licensee may install an alarm indicator,
which is not considered advertising.
1.12. Pharmacies must have its own name or
number.
1.13. Pharmacies have the right to buy and
sell except medicines, related products list for that
determined by the MOH.
1.14. Licensee must notify State service of medical
means of all changes in data specified in the
documents attached to application for a license. In
the event of such changes, the licensee shall, within
ten working days to submit to the authority Licensing
a notification in writing together with documents or
their copies confirming these changes prescribed by
legislation.
Licensee shall, within not less than three years save
documents confirming the purchase or sale of the date,
name, number, expiry date and series received and
delivered medicines information buyer (supplier) and
details of its license. Must be possible to track the
movement of each batch vehicle.
Purchase of medicines can be made only in entities that
are licensed to manufacture medicines, wholesale drugs.
Issue (sales) drugs may conducted:
entities that have licenses for wholesale trade remedies;
business entities that are licensed to manufacture
medicines (for use in production);
business entities that are licensed to retail trade
remedies;
directly to health care institutions.
Unit 3. LICENSING IN PHARMACY.
2. Special requirements
2.5. In retail trade remedies:
2.5.1. Retail drugs is only through
pharmacies and their units (and pharmaceutical
items pharmacy), except as provided by law.
2.5.2. In rural areas, in the absence of
pharmacy (Structural units) Retail Drug on the list
established by order of the Ministry of Health, may
be paramedics, medical and obstetric stations,
village a district hospitals and dispensaries under
the contracts, concluded with an entity that has
the appropriate license provided that the vacation
will be a person with medical education.
2.5.3. Pharmacies and their units to traders
finished product, including manufactured in
Pharmacies in the manner prescribed by law.
2.5.4. Do not send out prescription drugs
without prescriptions.
You let go without prescription medicines for
The list of drugs approved for use in Ukraine, which
are sold without prescriptions to pharmacies and
their structural subdivisions approved by the
Ministry of Health Ukraine from 02.11.2009 N 793
(z1157-09), registered in Ministry of Justice of
Ukraine on 01.12.2009 N 1157/17173 (Hereinafter the List) or under the terms of release as defined in
leaflet and / or leaflet / insert these drugs.
2.5.5. In the hall of public service in display cases in
glass and open closets (to which no public access), etc.
permitted to place medicines sold without
prescription, and those for prescription of mandatory
marked "Issue a doctor's prescription.
2.5.7. An entity that carries out activities
Drug retailers should:
ensure the availability of all necessary
facilities, equipment and equipment for proper
storage and trade of pharmaceuticals means;
have the required number of staff who is
responsible qualification requirements set by
Chapter three of this section;
create the necessary conditions for
accessibility of persons with disabilities
physical abilities to pharmacies.
adhere to certain general and specific
manufacturer storage conditions of
medicines;
have in the hall of public service information on the
availability license (copy of license), especially the rules
about dispensing drugs address and telephone number
of the entity that owns and pharmacy units, address and
phone number state agency for consumer protection,
address and number of territorial bodies of state control
as drugs, as well as book reviews and suggestions,
ensure the establishment and functioning information
booth or terminal;
ensure that mandatory minimum range of drugs to
pharmacies, which is determined Ministry of Health of
Ukraine;
comply with the law regarding the control drug
quality and have a plan for urgent action removal if
needed drugs with implementation;
ensure the safety of medicines;
keep for at least three years of documents
evidence of purchase, indicating name, date, form
issue number, expiry date and the series obtained
product, the manufacturer, the supplier and details of its
license;
identify an authorized person must have
completed higher Pharmaceutical education, get a
qualification level specialist - an expert, get a certificate
of assignment (Confirm) the title of pharmacist general
practitioners (experts, who graduated from university
after 1992) or total pharmacy and have experience of at
least two years (the duties of the authorized person
responsible for the system of quality medicines in
pharmacy, located in rural areas can rely on person of
pharmaceutical education, which has gained
qualification level of the specialist - junior specialist BA);
provide for every industrial premises
registration and control temperature and relative
humidity, all health measuring instruments and
conduct their regular metrological verification.
2.5.8. For pharmacies that make medicines
binding is the presence of the current State
Pharmacopoeia of Ukraine.
2.5.9. To support activities of retail
pharmacy must:
a) withdrawn from the position in a separate
housing home or in the built (built on) isolated
buildings on the ground floor with a separate self
emerges from trading hall except as provided in
these
Licensing Conditions.
Arrangement allowed the total input vestibule
provided providing free access to the pharmacy
and compliance in lobby sanitary requirements
set for pharmacies. Area common vestibule is
not included in the minimum area of pharmacy.
Allowed placement of the hall is a public
service only on the first floor if its floor level not
below / above planning ground level more than
0,5 meters.
If the pharmacy is isolated
dekilkapoverhove (Including basement, ground
floor or basement) rooms and has several halls
of public service, one of them must be located on
the first floor.
Pharmacies are allowed in commercial
areas centers, medical and spa
institutions, hotels, airports, railway
stations, in an isolated room on the first
floor without installation of separate
independent exit outside, subject to the
requirements of paragraph 2.5.7 of this
item.
In rural areas (the village) may also
place Pharmacy in the Village public
buildings, mail without arrangement
individual self emerges;
have room services and manufacturing
premises: desired area or room for taking
drugs room (zone) where different groups of
medicines according to requirements specified
by the manufacturer. Entry to the production
premises shall be conducted through the joint
space Use of population (corridors, etc.).
Minimum total floor area of storage of
medicines can not be less than 10 sq.m.
Allowed construction of the hall of public
service free access to medicines that the
counter according to the list (z1157-09), and
other goods, by law, if in the hall experts and
consultants (pharmacist, pharmacists);
c) to service-domestic premises: premises staff
dressing room with a washstand (for pharmacies
located in rural and regional areas where there is no
communication (Water, sewerage), allowed the
location of restrooms outside the pharmacy while
the pharmacy must be equipped with a separate
space for sanitization of hands), premises or closet
for storage of business inventory. For pharmacies
located in areas where no drainage is permitted
arrangement in the dressing room biotoilet. Entry to
the service and domestic premises can not be done
through production facilities. Minimum floor area for
staff may not be less 8 sq.m.
The total minimum area of pharmacy shall be:
to pharmacies engaged in trafficking drugs not less than 50 square meters. meters (square
trading hall - at least 18 sq. m);
to pharmacies located in rural areas - not
least 40 square meters;
pharmacies for the manufacture of
medicines warehouse premises Pharmacies
include all facilities necessary for the proceedings
activities of retail drugs, except cases under these
Licensing Conditions and premises for the
manufacture of medicines, staff and floor area
determined by the MOH.
Production area pharmacies must be equipped
equipment to ensure proper storage of medicines
means (cabinets, shelving, refrigerators, safes, etc.)
and facilities for control the temperature and relative
humidity. Hall of public service must be equipped
with equipment to ensure appropriate storage of
medicines under the implementation and the means
to control the temperature devices to protect workers
from direct droplet infection.
Sanitary condition of premises and equipment
Pharmacies shall comply with sanitary and epidemic
control regime
pharmacies, set by current regulations acts.
Premises and equipment room pharmacy
staff should provide for the maintenance
and preservation of private and special
clothing according to the epidemiological
profile and the possibility of using food
and recreation (fitted wardrobes for
clothes, refrigerators, furniture). Use
room staff as corridor is not
allowed. Pharmacy should have a first
aid kit (medical and other means) to
provide physician care.
Licensee during the transport of medicines must
ensure the storage of medicines under with the
requirements prescribed by the manufacturer.
The vehicle for the transport of medicines
should enforce storage conditions specified by the
producer drugs and allow the systematic cleaning of
wet use of disinfectants.
Do not transport drugs to public transport,
intercity buses communications, Rail passenger
transport in post shipments.
Pharmacy items are placed in separate
premises with or without selection by highlighting the
room service population in the capital medical homes
institutions. Area drugstore can not be less than 18
sq.m.
In the absence of villages medical institutions and
pharmacies may Download drugstore in any other
premises comply with these license terms.
05/02/1916. The room must be equipped
drugstore shelves, cabinets, refrigerator, safe or metal
cabinet for storage of medicines, the place for
sanitization of hands Separate storage closet for your
personal and working clothes, closet for storage of
business inventory separately for purpose.
05/02/1917. Pharmacy items ready to traders
medications, prescription and non prescription doctor.
02/05/1918. Pharmacy kiosks are placed in
separate premises (at least 8 meters) without extracting
trading hall only in capital structures: for plants, factories,
railway stations, airports.
Pharmacy booth can be placed on the first
floor residential and public buildings if there
is a separate entrance, supply of utilities
(water, sewerage, heating), availability of
space and ventilation premises not less than
21 square meters, including 8 m - Download
Zone equipment jobs personnel, 10 sq.m Service Area population, 3 m wardrobe.
For booth located in areas
where there is no Communication (water,
sewerage), may be placed in Drink biotoilet
and resettlement places for treatment of
hands.
For booth located in the village are allowed
Download the lavatory outside pharmacy,
while in pharmacy must be equipped with a
separate for sanitization of hands.
Pharmacy premises must be equipped
shelves, cabinets, refrigerator and place for
sanitization hand, a case for separate
storage of personal clothing and special
clothes and a closet for storage of business
inventory separately for the
purpose.
Pharmaceutical stand ready to
traders only drugs, dispensing without
prescription.
Operation of pharmacies and their divisions entity
established in consultation with relevant local
executive authority or body local government. If the
planned closure of pharmaceutical facility for repair,
maintenance or other re- work entity must inform the
advance but no later than 5 days, in writing
informing territorial State Inspectorate for Quality
Control Ministry of Health of Ukraine and putting,
along with information about treatment
announcement of the date and period of closure and
inform the licensing authority, the term message
which by law.