How To Start A Pharmacy In Ukraine: The Most Frequently Asked Questions And Their Practical Solutions
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We are often addressed with queries, “How to start a pharmacy in Ukraine?”. But this is only one of the questions that interest those who are going to set up a pharmacy business. It’s worth mentioning that the process of starting a pharmacy involves many nuances:
finding suitable premises for the pharmacy;
correct employment of the pharmacy staff;
the need to equip access to the pharmacy for people with disabilities.
There are more complicated questions, such as what to do if you want to set up a specialized pharmacy and sell precursors there as well? Or is it possible to replan the premises after all the documents for the pharmacy license have been submitted?
Today we will talk about the most interesting situations that arise in the process of starting a pharmacy in Ukraine. We will talk about the problematic issues and their practical solutions.
What to do if the actual area of the pharmacy is slightly different from that stated in the specifications sheet?
Of course, the information in the specifications sheet must be up to date. If there has been a redevelopment of the premises, then before submitting documents for a license, you need to reissue the specifications sheet. But it happens that as a result of insulating the walls from the inside, their thickness increases. Accordingly, this somewhat reduces area.
In this case, there are several scenarios:
the information may specify the real area of the room;
the information may specify the area from the specifications sheet, although in fact it is already different.
In both cases, an on-site inspection establishes the fact of a mismatch. But if in the first case it is just a mismatch, in the second case it is the filing of false information, which can be the reason for the rejection of a license without the right to re-apply in the next three months.
Our lawyers analyze each specific situation. With many years of practical experience, we know, for example, that often the State Service of Ukraine on Medicines and Drugs Control takes the side of the applicant / licensee and proceeds from the fact that if during the inspection there were no more violations, and the total area of the premises, as well as the area of separate rooms of the pharmacy, meet the licensing regulations, then the applicant / licensee meets the requirements for the premises of a pharmacy in Ukraine. That is why we take care that there are no remarks to our Clients’ pharmacies. This is a guarantee of a positive decision of the State Service of Ukraine on Medicines and Drugs Control.
Please note! There are cases when discrepancies are significant. Then our specialists will advise you to reissue the specifications sheet, analyze other documents for inconsistency with the licensing regulations, and make proposals for their correction.
Related article: Do I Need a Specifications Sheet for a Fharmacy
Can a pharmacy be located in the premises of a healthcare facility?
At first glance, the licensing regulations allow for this option, because the requirement to function in a prevention and treatment facility sounds somewhat vague.
A prevention and treatment facility can be considered the entire complex, which is part of it. But if you go deeper into the analysis of the legislation, it is obvious that the pharmacy must be located in the building of the health care institution.
The licensing authority also insists on this point of view.
Related article: A Wheelchair Ramp in the Pharmacy
Who shall order a conclusion on the compliance of the wheelchair ramp with building standards: The landlord or the tenant licensee?
The licensing regulations require the applicant to ensure that the pharmacy is accessible to people with limited mobility. This shall be evidenced by an expert opinion on the compliance of the wheelchair ramp with state building standards.
It follows that it is the licensee who needs this conclusion. But if the landlord knows that its premises can be used as a pharmacy, then the landlord himself can order such a conclusion, in order to lease the premises in full readiness for use.
Attention! These conclusions are registered. That is, they indicate the customer, the name of the sole proprietor or the name of the company. It often happens that the premises have already been used for a pharmacy, which for some reason is closed. And the conclusion has already been obtained for it. But if the holder of the conclusion - the previous owner of the pharmacy, which was the tenant as you, then the conclusion needs to be re-issued.
Within the framework of pharmacy license services, we provide all the information to Clients about the conclusion, where and how to obtain it. We provide templates, explanations, and, if necessary, advice on independent experts.
How to pass a pharmacy inspection before getting a license?
You will get a Certificate based on the results of the inspection. Its form, in fact, is identical to the form of the information that was submitted when applying for a license. Therefore, the information in the Certificate must coincide with the information in the statements. Otherwise, you will be refused a license.
The key role here is played by the basis for the refusal: the applicant does not meet the requirements or has submitted unreliable information. In the second case, the applicant can not re-apply for a license within the next three months. Even a mechanical error can be considered misrepresentation.
Warning! Never refuse a pre-license audit!
There were cases when inspectors of the local State Service of Ukraine on Medicines and Drugs Control called the license applicant and asked him if he had a certain list of documents. And if a person could not answer clearly, then he was advised to refuse the inspection, they say, anyway we will come and make an unsatisfactory Certificate, so why go in vain?
If a person applied for a license and an inspection was sent to the premises, then it must take place. If the applicant refuses the pre-license inspection, the central State Service of Ukraine on Medicines and Drugs Control considers it unreliable information provided with all the consequences that come with it.
You can refuse an inspection only for good reasons. For example, for health reasons. If the applicant refuses the inspection without a valid reason, it means that he is not ready for it. Consequently, the information declared in the information was false.
Our lawyers will not only help you prepare the documents to obtain a Pharmacy License, but also advise on the pre-licensing inspection of the pharmacy: what to say, what to expect, how to react.
With our help, you will obtain a pharmacy license simply and on the first try.
Related article: Tips for Passing a Licensing Inspection
What to do if the pharmacy failed the inspection and the license was denied?
The final decision is made by the central State Service of Ukraine on Medicines and Drugs Control on the basis of the Certificate drawn up by the local inspectors.
However, in certain cases, the commission may take the side of the license applicant, if it sees that it generally meets the requirements of the licensing regulations.
Our lawyers will make sure that you don’t face such a situation at all. But if you are refused a Pharmacy License, don’t hesitate to contact us and we will find the best solution for you.
Legal services for obtaining a Pharmacy License in Kyiv and Ukraine
Our lawyers offer you a full range of services for obtaining a Pharmacy License in Ukraine:
Consultation on starting a pharmacy in Kyiv or any other town/city of Ukraine;
Analysis of your situation and existing material and technical basis;
Preparation of documents for applying for a Pharmacy License;
Submission of documents and monitoring their consideration by the licensing authority;
Guaranteed receipt of a Pharmacy License.
When you contact us, we will analyze your documents and help you decide whether:
you have premises suitable for a pharmacy, and how best to replan the rooms;
you have created adequate conditions for people with disabilities;
your staff meets the qualification requirements.
Answers to these and many other questions will help you save money and, most importantly, time. Often license applicants, without realizing it, mislead the licensing authority. For example, when answering “yes” to the question “Have you created adequate conditions for people with disabilities?”. But it turns out that the wheelchair ramp or the documents for it have certain shortfalls.
The licensing authority qualifies this as deliberate misrepresentation, and rejects the license without the right to re-apply within three months. We will help you to avoid such mistakes, taking full care of the preparation of documents and the licensing procedure.
Do you want to get a Pharmacy License? Don’t hesitate to contact us. We will definitely help you!
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