License for sale of medicines (drugstore license)
License for sale of medicines (drugstore license)
What we do
Obtainment of license for wholesale or retail of medicines includes:
- provision of advices on all matters related to preparation of licensing documents;
- consultation on equipment selection for a drugstore;
- analyzing personnel’s required documents (head of a drugstore, authorized person);
- preparation of documents drafts required to obtain a license;
- providing help on passing drugstore’s examination;
- providing the whole procedure of examination your documents by state bodies.
Price for a drugstore license
We get a drugstore license for companies and entrepreneurs from all regions of Ukraine. It’s not even Kyiv but regional centers and other Ukrainian cities very often – Cherson, Kropivnitsky, Charkiv, Ternopil, Rivne. The price is the same for every Client. The reason of it is a procedure of getting a drugstore license – Clients don’t have to come to Kyiv and sending exes are included into the price. You can find out about our experience here.
The cost doesn’t include an official license fee (state tax). The size of it is equal to one minimal wage which is defined at the moment of issuance a license.
We provide services on getting other pharmaceuticals licenses. For example, you can get a license for wholesale of medicines for 10 000 UAH.
Cost of services is discussed before beginning of cooperation. It doesn’t increase during the procedure which allows our Clients to stay within agreed expenses.
Cost of getting a license for retail of medicines in drugstore or in another institutions begins from 4000 UAH. But in the most cases a real price of getting license increases to 6000 UAH. It includes a guarantee of getting license during the first Committee’s meeting.
Successfully rendered services
Drugstore license obtained in August of 2017
Provided a procedure of obtaining a drugstore license for our Client in August of 2017.
Drugstore license obtained in July of 2017
Our lawyers helped a client from Zakarpattya region to open his own drustore and license it.
Decision on issuance of drugstore license received in May of 2017
Our lawyers helped a client from Kyiv to open his own drustore and license it.
Decision on drugstore license extension obtained in March of 2017
Added new drugstore location into the official license register for a client of ours from Kharkiv.
Drugstore license obtained in December of 2016
During the last session of the licensing commission our lawyers helped a client from Kharkiv to get drugstore license.
Drugstore license received in October of 2016
The license was obtained for our client's drugstore in Kiev.
Drugstore license received in August of 2016
Drugstore license was received for a sole trader from Lviv region of Ukraine.
License for retail of drugs received in May of 2016
The drugstore license was received for a company located in Kiev.
License for retail of drugs received in April of 2016
Our lawyers helped a sole trader from Vinnytsya region to obtain license for his drugstore.
Drugstore licenses received in March of 2016
These drugstore license were obtained by our lawyers for sole traders and company from Zakarpattya, Kiev and Cherkasy regions of Ukraine.
The licenses were obtained in November of 2015
The drugstore licenses were obtained for LLC of client from Kiev and sole trader from Lviv region
The licenses were obtained in November of 2014
The licenses were obtained for Clients from Kiev and Kherson region.
The license was obtained in September of 2014
The licenses was obtained for Client from Kiev region.
The license was obtained in November of 2013
The license was obtained for Client from Lugansk region.
WHY CHOOSE US
Our cooperation is profitableA drugstore license is one of the documents which is issued only after examination premises, personnel and required equipment by state bodies. The longer procedure of getting license will be the bigger losses will get your company.
Provided a successful passing of examinationWe have got drugstore licenses since 2006. We know requirements for it perfectly. That's why we can guarantee you successful and quick passing of drugstore's examination if you choose our company.
ANY QUESTIONS LEFT?
Our lawyers will advise you!Ask a lawyer
- Documents which verify the right of lease or ownership of premises, where will located drugstore
- Scheme of premises in arbitrary form (Clients usually give a scheme of Technical Inventory Office or a sanitary and technical passport)
- Copies of diplomas about higher education, qualification certificates of head’s drugstore and authorized person)
Required documents for a drugstore license
If you take a decision to get our service then you have to send via e-mail or fax:
- documents which confirm the right of lease or ownership of premises, where will located drugstore
- scheme of premises in arbitrary form (Clients usually give a scheme of Technical Inventory Office or a sanitary and technical passport)
- copies of diplomas about higher education, qualification certificates of head’s drugstore and authorized person)
- information about company or entrepreneur which are put into application license form;
- other information about personnel and premises.
Confirmed document about absence of control over your company from countries which carry out armed aggression against Ukraine is prepared by our lawyers.
The drugstore’s passport had been cancelled since the first of August 2012.
You can download application form and other required documents for a drugstore license below.
REFERENCES FROM OUR CLIENTS
Savorona N., Sole trader Savorona N.
O. Reshytnyak, Sole trader O. Reshytnyak
L. Chervonyuk, LLC "Vitalux"
Important to know
License for retail of medicines is called a drugstore license usually. The reason for it is that drugstores are the main and only institution which can retail medicines. Pharmacy points are not so popular as drugstores. Moreover they are chapters of drugstores. It is impossible to open Pharmacy point without drugsore.
At the same time you don’t have to take for drugstore license for a pharmaceuticals license. Pharmaceuticals license can include not only retail of medicines but also wholesale of medicines. Also a pharmaceuticals license takes for a license for production medicines often.
Terms of getting a drugstore license
We elaborate documents which are required for getting a license during one day since we had got the whole list of documents from a Client. So it depends on communication between Client and a lawyer.
It takes 12 days for issuance a drugstore license since the moment of submitting documents till the moment when order will be published on website. This term is consisted of 10 working days when sate body examine premises and personnel and 2 days for publication of results.
Validity term of a pharmaceuticals license
Every lisence doesn’t have a validity. This rule applies across the whole territory of Ukraine.
You can read or hear sometimes that validity of license is 5 years. This is an old information, it was actual till the end of 2010.
How can I get a drugstore license by myself
If you want to try to get this license by yourself then information about when and how you can submit documents may be useful for you.
But we recommend to ask for professional help because it will save your time. You will have a drugstore license in two weeks with our lawyers’ help since the moment of signing an application form and other required documents. You can check out cost of our service.
AND BEST QUALITY PROVEN BY YEARS OF PRACTICE!
Volodymyr Gurlov, Managing partner
Procedure of getting a drugstore licenseProcedure of getting a drugstore license – Getting a license copy – Reissue of a drugstore license
Procedure of getting a drugstore license is regulated by the Law of Ukraine “On licensing some types of activities” and by the Licensing regulations. These acts define which types of activity must be licensed, requirements for premises and personnel of a drugstore, and also procedure of getting a license for opening drugstore.
General information about a drugstore licenseA drugstore license gives a right to retail medicines in some required premises. Outgoing retail and internet-retails are out of law. For getting a license you must have required rented or your own non-residential premises (drugstore, pharmacy point, pharmacy storage) where retail will be held.
A pharmacy point is a chapter of drugstore. That’s why you won’t have a right to sell medicines there if you hadn’t got a drugstore license. It is forbidden to transfer a license to other company by law. Such transfer is reason for license revocation. Validity term of license for wholesale or retail of medicines is unlimited.
Requirements for drugstore’s licensingThere are two main groups of requirements – requirements for premises and requirements for personnel. Main requirements for premises are:
- structures of all drugstore’s premises (trading room, storage, additional premises). The minimal square depends on location of drugstore – if drugstore is located in city then its size must be not less than 50 square meters; if drugstore is located in village then its size must be not less than 30 square meters;
- drugstore’s equipment. There must be protective glass shield against airborne diseases, strongbox, cupboards, racks, thermometer, hygrometer etc;
- observance of sanitary and hygienic rules. There must be sewerage, heating, opportunity for everyday wet cleaning;
- conditions for people with disabilities to get into a drugstore. In the most cases there are ramps;
- requirements for keeping medicaments. Minimal size of storage must be not less than 10 square meters (for cities) and not less than 6 square meters (for villages). It is forbidden to keep other goods with medicaments.
Premises must be isolated on the first floor and have separated entrance. But there are exceptions. If drugstore is located in medical institutions then it can hasn’t separated entrance and be on every floor.
Requirements for personnel are different for city and for village drugstores. For example, authorized person who examines medicaments’ quality in city drugstore must have higher pharmaceutical education. At the same time this person must have a certificate of pharmacist or must have pharmacist qualification. He also must work in this sphere not less than two years.
At the same time specialist who doesn’t have this experience can work in a village drugstore.
We need to admit that procedure on issuance licenses in this sphere is variable and company examines your documents every time before submitting them to state bodies.
Procedure of getting a drugstore licenseA drugstore license is issued by State Service of Ukraine on Medicines and Drugs Control which is located in Kyiv.
The main required documents for getting a license are an application form, document with information about material base and a power of attorney.
Documents are examined during 10 working days. There are also 1-2 days for publication results on the state body’s website. Paper license hadn’t been issued since 2017.
In spite of a simple list of required documents for wholesale or retail of medicines, a lot of drugstores can’t fill it correctly. So you have to submit documents a few times and wait for decisions nearly 2 weeks. This brings your company to losses and stopping activity of a drugstore. Our company can prevent it and here you can read about our services’ price.
There is an outgoing examination after submitting documents. As a rule, it is held by local charters of State Service of Ukraine on Medicines and Drugs Control. By the time of examination your premises had to be prepared, reconstruction must be finished and there must be required equipment. There is also must work a pharmacist. If you are an individual then you must sign labour agreement with him and register it in centers of employment.
The target of examination is checking conformity of real premises to submitted documents. Act is formed after the examination.
A drugstore license can be issued only after full preparing of premises. That’s why licensees won’t have to reconstruct something or buy additional equipment when they got licenses.
If there are no any remarks for your premises then you will get a license in 10 days. An official license fee is paid to state budget according to drugstore’s situation via local treasuries. The code of fee is 22011800.
If you are an individual then we can submit documents by the power of attorney which is confirmed with seal.
Getting a copy of drugstore licenseThere is no state body’s obligation to issue a copy of license according to the law.
If there is an additional point which must be registered then you submit an application on inclusion to the Register of additional information. This procedure doesn’t differ from the previous one.
Premises and personnel are examined by local state bodies during outgoing examination.
Reissue of a drugstore licenseA pharmaceutical license is reissued only if information, which was putted to documents, is changed. For example, if legal address or company’s name are changed. The change of drugstore’s location is not the reason for license’s reissue. You must submit just an application on inclusion to the Register of additional information.
This procedure is the same or even simplified than getting a new license. It depends on changes which were happened. Required documents which confirm changes are submitted to State Service of Ukraine on Medicines and Drugs Control.
You must submit these documents during a month from the moment when changes were happened or a license will be revoked. If it happened to you then call on to our lawyers.
How can you get a drugstore license in our company
As it was said, our company provides services on licensing of drugstores from all over Ukraine. You have to contact our office which is located in Kyiv via phone, email, fax etc.
After discussing terms, cost, procedure of payment and making a prepayment we launch the project.
After final edition of required documents and preparing a power of attorney Client sign and send to the company originals of documents:
- application form;
- document with information about material base;
- certificate about non-control;
- power of attorney.
Client must pay an official license fee and keep a bank receipt after publishing a positive decision on the website. You can find out information for making payment in local treasuries or state tax services (the code of fee- 22011800). Client can give money to our company and we will pay it and send receipt by ourselves.
Procedure of getting a drugstore license may be changed if you wish.
“Turnkey” license for wholesale or retail of medicines can be got for you by our company.
If you want us to provide you with this service then contact our specialists.