Unit 2. LICENSING IN PHARMACY

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.

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

A license is the document of state standard which confirms the right of licensee to introduction of economic

activity for certain term on conditions of implementation of the licensed terms.

A licensee is a management subject getting a license to realization of definite

type of economic activity, subject to licensing.

APPROVED Order of the State Inspection Quality Control drugs Ministry of Health of Ukraine 21.09.2010 N 340

LICENSEbusiness activity Drug Manufacturing, wholesale, retail pharmaceuticals

Head of State service of medical means – Oleksij Solovjov

By law, subject to licensing:

•production; •wholesale drugs;• retail trade in drugs.

State service of medical means decides to grant a license or refusal to issue in time no later than ten working days from the date of application for a license and documents attached to the application. 13. About the decision to grant a license or denial of the license is sent (issued) applicant in writing within three working days from the date decision.

The reasons for the decision to refuse licenses are: invalidate the data in documents filed by the applicant for license;      discrepancy the applicant in accordance with the submitted

documents License terms set for the type of business activities specified in the license application.      In case of refusal to issue a license based on the detection false data in

documents submitted by the applicant on the grant license, the entity may submit to State service

of medical means new license application no earlier than three months the date of the decision

refusing to issue a license.

   In case of refusal to issue a license based on the discrepancy applicant's license conditions set for the type of business activities specified in the license application, subject entity may

submit to the Ministry of Health State service of medical

means new application for license as the reason for that became the basis for refusal to issue

the license.

License issued to the applicant personally or by his authorized person no later than three

business days after receipt document confirming payment of license fee. If the applicant within thirty calendar days sending him a message about the

decision to grant license did not submit the document confirming payment of license, or not addressed to State service of medical means executed a

license, then State service of medical means which formalized license has the right to terminate the license or decide on the recognition of such a

license.

Licensing is registered in the numbered laced, and the sealed book of applications and issued

licenses in the prescribed form (Annex 3). Journal of statements and issued licenses conducted separately for each type of business activities

subject to licensing. For each place where the separated unit that fight

economic activity based on obtained a license, issued licensee State service of medical means certified

copy of his license which is registered in the logbook applications and issued licenses.

In case of liquidation separate unit licensee who has led the business activities in accordance with the received license, or in case of a separate proceeding licensee's

business unit in accordance with the received license the licensee shall, within seven working days from the date eliminating separate unit or from the date of termination

of a separate unit submit an notice in writing to State service

of medical means or send it by registered mail.      

If you have any grounds for license renewal licensee shall, within ten working days to submit State service of medical

means license renewal application (Annex 5) along with the license to be reissued, and relevant documents or notarized

copies, which confirm these changes.      

A licensee who has submitted an application for license renewal and related documents may be operating at basis of the certificate of adoption of the above documents to review

issued State service of medical means.     

In case of loss or damage to license the licensee shall apply to the Ministry of Health State

service of medical means a statement about issuance of duplicate licenses (Appendix 6).

In wholesale and retail drugs allowed only registered in Ukraine drugs, if the quality certificate issued

manufacturer. In the case of storage in the form of certificates of quality scanned copies of certificates

licensee must provide them paper copies (on demand), stamped subject shall, not later than within two days.

     Trade or substandard medicines such term life has expired or for which no certificate of quality given

manufacturer, is prohibited.      Trade remedies, made from pharmacy violations of

conditions of production, is prohibited.      The entity must keep the certificates as a producer

(on paper copies or scanned copies electronic media) on a series of pharmaceutical products sold entity within three

years.

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.

     2. Special requirements 2.4. In wholesale trade remedies:

     2.4.1. Wholesale drugs is through the pharmacy database (warehouse). Manufacturers of medicines

carry out the implementation of its own products based on license to manufacture drugs.

     The licensee must provide:      purchase and sale only medicines that

incorporated under the laws of Ukraine;      compliance with certain medical conditions of storage

manufacturer means (including during transport) and preservation medicines;

     prevent contamination of medicines;      operation of detection of any product that does

not meets the requirements (technical documentation, analytical and normative documentation of existing

standards), and effective procedures for withdrawal.

Pharmacy warehouse (base) placed in separate located specially arranged houses in isolated rooms in public buildings and auxiliary buildings industry on

any floor (subject to the requirements 02/04/1910 subparagraph of this paragraph) if the arrangement

loading and unloading area for the lot entrance (ramp with canopy, etc.) outside the front windows

of apartments with a constant stay of people.      For wholesale medical gas pharmacy

warehouses (base) must meet the requirements defined by law.

Accommodation pharmacy database (staff) in residential buildings, athletic facilities, schools,

education and childcare institutions, cultural institutions, sports, education and social security, medical facilities, shops operation is permitted if

appropriate separated buildings for other purposes.      2.4.3. Pharmacy warehouse (the base) must be

composed of:      production facilities: separate room, area or

zone for Acceptance and storage of medications and dispensing them, auxiliary materials and packaging the

total area of not less than 250 sq.m. Belong to the production room (zone) in which received, stored

medicines room (zone) acquisition and dispensing of medicines (Expeditionary) room (zone) storage

auxiliary materials and packaging drug quality control, storage, quarantine products,

The composition, location of production facilities and its area should ensure the continuity of a

process (receiving, quality control, storage, and dispensing equipment means). If there are drugs that require special storage conditions (Strong,

poisonous, narcotic, Psychotropic, immunologic, termolabilni, flammable, flammable, explosive

products, herbal and other raw materials) must be properly equipped with separate room (zone) for

their storage.

The requirement for production area (zones) does not apply on the premises of pharmaceutical warehouses (databases) of business entities

wholesale trade only medical gases;      minimum set of household and auxiliary

buildings: office staff (0,75 m per worker of one shift, but not less than 8 square meters),

restrooms (estimated but not less than 2 meters), space for storage items cleaning (4 meters) or

cabinet, depending on a restaurant. To domestic premises also include: wardrobe, shower room, to

eat (dining room) and more. In office facilities include:

room preparation and processing of supporting documentation, study head, deputy head of cabinet and

cabinet personnel participates in the technological process: claims processing customer returns,

preparation of documents for process execution acceptance, integration and shipment of products,

premises (Zones) for automated manufacturing equipment storage, disinfection facilities for the

preparation of solutions and more. To auxiliary facilities include: Camera, archive server, Storage Space for

household equipment, rooms health, educational classrooms, etc., and their area is included in the total

area of the office-residential premises passport chemist institution. Premises (area) for storing cleaning

accessories production facilities and premises (area) of working storage means for handling operations can be

in the premises.

 Corridors, lobby, staircases, lift shafts, Electrical distribution, boiler, ventkamery (mine) are additional premises.

     Accommodation facilities pharmaceutical composition should exclude the need for changing the passage of workers

in special through clothing production facilities.      

Entry to the household and auxiliary buildings can not conducted through facilities, except Licensing under these

conditions.      Quality licensee shall provide a supply drugs to

customers within the period agreed between supplier and customer. Good quality of medical facilities must be

maintained in the network without the wholesale any changes in their properties to retailers. System traceability as drugs established by the licensee, should ensure detection of any

unsafe and counterfeit products.

The licensee must have sufficient (depending on capacity institution) of

skilled workers. Personnel must meet the qualification requirements set out in Chapter three This section licensing

conditions. Management personnel of the pharmacy (Base) where drugs should have

sufficient authority, appropriate qualifications and experience to provide

proper storage of medicines and treatment.

Each pharmacy stock (base) should be appointed at least one authorized person with appropriate authority and

is responsible for development, implementation and operation of

quality. An authorized person must personally serve duties, have higher pharmaceutical education and work experience for specialty at least two

years.     Licensee shall provide the

increase on a regular basis staff whose activities may affect the quality products. Facts need training protocol.

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.

PART 2PART 2Unit 3. LICENSING IN

PHARMACY. 2. Special requirements

2.5. In retail trade remedies:

 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.      

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.

2.5.7. 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.