Lecturer Assoc. prof. M.V. LelekaLecturer Assoc. prof. M.V. Leleka

Department of Management and Economics of Department of Management and Economics of PharmacyPharmacy

LICENSING IN PHARMACY. LICENSING IN PHARMACY. Special requirements Special requirements

In retail trade remedies: In retail trade remedies:

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 ShopOne can see several departments in chemists shop. They are: 1.prescription department, 2.non-prescription department, 3.ready-made drugs department,4.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.