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Tobaksgården 3
8700, Horsens, Denmark
+45 2947 1278
10, Svyatoho Teodora Square
Lviv, 79019, Ukraine
+38 032 2970597
Tobaksgården 3
8700, Horsens, Denmark
+45 2947 1278
10, Svyatoho Teodora Square
Lviv, 79019, Ukraine
+38 032 2970597

Article

Starting your own business. Specifications on opening the pharmacy.

STEPS ON OPENNING THE PHARMACY

 

Step I. Choosing an organizational form in which the pharmacy is going to act. 

 

 The most common forms of running your own business in Ukraine is PE (private entrepreneur) and LLC (Limited Liability Company). When choosing the form which provides a creation of a legal entity (LLC), you should take into account not only its advantages/disadvantages, but also regulations by law concerning "internal issues" (order of creation of a statutory fund, its increase or decrease, transfer of shares, etc).

Also, at this stage you will need to choose activity, that will be provided by your legal entity (the production of drugs or wholesale trade/ retail trade of drugs) and to choose CVED (class of economic activity).

 

Step II. Finding the place for the pharmacy that should meet the requirements established by law.

 Requirements to the place depends on the type of activity (the production of drugs or  wholesale trade/ retail trade of drugs), types of pharmacies and pharmacy location (city, village, etc). For example, the pharmacy located in the city has the requirement to the size of place that should be not less than 50 s.m., and shop floor area of at least 18 s.m., etc. When you are lucky to find the place that suits best for the pharmacy the next step will be signing a contract of sale or lease contract. To put all conditions of the contract in a right way you won’t dispense with legal assistance.

 

Step III - Preparation of documents for obtaining a license for production or selling drugs.

 In order the pharmacy function legally, the set of rules should be followed. Licensing document is the one you should receive first.

Licenses for production/wholesale/retail trade of drugs is issued by State Service of Ukraine on drugs.

Documents to be submitted for a license:

-application in established form

-documents needed in accordance with the license conditions (its differ for production of drugs and their trade).

State Service of Ukraine on drugs has 10 working days to make a decision whether to give/refuse to give the license after all needed documents were submitted.

After receiving a positive answer from State Service of Ukraine on drugs, it is needed to pay a charge in amount of one minimum wage (starting from 01.09.2015 it is 1378 UAH).

Then, within 3 working days after payment, the license is going to be issued.

 

Accreditation of the pharmacy can be held on a voluntary basis.

 Stage IV – Meet the requirements for the production /sale of drugs prescribed by the laws of Ukraine.

 

Requirements for the place room of the pharmacy

Order of the Ministry of Health from 31.10.2011  № 723

Sanitary requirements that must be followed.

Order of the Ministry Of Health from 15.05.2006  N 275 

Appropriate staff of workers (with a pharmaceutical education)

Order of the Ministry Of Health from 28.10.2002 N 385 

Conformity of the prescription to the provided requirements

Order of the Ministry of Health from  19.07.2005  № 360 

Conformity of pricing in a pharmacy to the provided requirements

Regulation of a Cabinet of Ministers of Ukraine from 17.10.2008 № 955  

Requirements to production/import/trade of drugs

Law of Ukraine “On drugs” 

 

 WHAT YOU SHOULD KNOW WHEN STARTING PHARMACY BUSINESS

 

The distance (via the Internet/mail) sale of drugs and sale of drugs through any institutions other than pharmacies sale is forbidden.

In case of production of drugs with the purpose of their further selling, one of the stages will be the state registration of produced drugs and receipt of a certificate that states the term, during which the drugs are allowed for use in Ukraine.

Wholesale trade/ retail trade of drugs is carried out under the terms of presence of quality certificate issued by the manufacturer or importer.

 

Pay attention that information that is given above is for general understanding.

If you need more detailed information on opening the pharmacy you are welcome to contact J&L Consulting team.

 

 

 

 

 

 

J&L Consulting