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How To Start A Pharmacy In Ukraine: The Most Frequently Asked Questions And Their Practical Solutions

We are often contacted with requests, “How to set up a pharmacy in Ukraine?” But this is only the first issue that interests those who are going to start a pharmacy business.

Today we will talk about the most interesting situations that arise in the process of starting a pharmacy in Ukraine. We will elaborate on practical problem issues and their practical solution.

What to do if the actual area of the pharmacy is slightly different from that declared in the room data sheet?

Of course, the information in the room data sheet must be up to date. If the premises have been redesigned, the room data sheet must also be reissued before submitting the documents to the licensing authority. But sometime the the walls become thicker as a result of their inside insulation. Accordingly, the area is slightly reduced.

There are several scenarios for this case:

  • To specify the real size of the room;
  • To specify the size of the room indicated in the room data sheet, although in fact it is already different.

In both cases, the on-site inspection will determine if there is a discrepancy. But if in the first case it is just a mismatch, then in the second case it is the submission of inaccurate information, which may be the reason why the license is rejected without the right to apply for a license within the next three months.

Practical decision or human factor. The State Service of Ukraine on Medicines and Drugs Control often takes the side of the applicant / licensee and if the inspection reveals no more violations and the total area of the premises, as well as the area of individual rooms of the pharmacy meet the licensing requirements, it decides the applicant / licensee fulfilled the requirements to the pharmacy premises in Ukraine. Thus, it makes a positive decision on the application.

In this case it is better to consult on how to act further and how to explain the situation to the licensing authority.

Related article: Do You Need A Pharmacy Passport?

The pharmacy is not located in the building of the healthcare facility, but within its territory: is this option possible?

At first glance, licensing regulations allow this option, because the requirement for a pharmacy to function in a treatment and prevention facility sounds somewhat blurred.

A treatment and prevention facility may be considered as the whole complex, which is included in it. But if we try to thoroughly analyze the legislation, it becomes obvious that the pharmacy must be located in the building of the healthcare facility.

The licensing authority also insists on this point of view.

Who should apply for a conclusion on the compliance of the ramp with the building standards: a landlord or a tenant who applies for a license?

According to the licensing regulations, the licensee shall ensure easy access to the pharmacy for persons with low mobility. This shall be confirmed by the expert’s conclusion on the compliance of the ramp with the state building standards.

In this view, this is the license applicant who needs this conclusion. But if the landlord knows that his/her premises can be used as a pharmacy, he/she can apply for such a conclusion to rent out the premises in full tenant-ready condition.

Please note! These conclusions are personalized. That is, they shall specify the client: the name of the individual entrepreneur or the name of the company. It often happens that the premises have been already used for a pharmacy, which left it for one reason or another. And such a conclusion has been already issued. But if the conclusion was ordered by the previous owner of the pharmacy, who was also a tenant, the conclusion shall be re-issued.

Related article: A Call Button In A Pharmacy

What are the requirements for the pharmacy premises in Ukraine?

The licensing regulations describe in sufficient detail the requirements for the pharmacy premises, including the area of individual rooms and wall coverings. You can learn more about the requirements for the pharmacy during the pre-licensing review from this material.

We prepared a separate publication about the requirements for pharmacy staff here.

If you want to know more about the peculiarities of starting a pharmacy in a village, read this publication.

How scary is the conclusion of the on-site pre-licensing inspection?

The conclusion is drawn up based on the results of the inspection. Its form is, in fact, identical to the form of statements submitted when applying for the license. Therefore, the information specified in the conclusion must coincide with the information in the statements. Otherwise, the license will be rejected.

Here the key role is played by the ground for refusal: the applicant does not meet the requirements or has submitted false information. In the latter case, the applicant cannot re-apply for a license within the next three months. Even a mechanical error can be considered a false information.

Please note! Under no circumstances should you refuse a pre-licensing inspection!

Sometimes inspectors of the local agency of the State Service of Ukraine on Medicines and Drugs Control may call the license applicant and ask questions about the presence of a certain list of documents. And if a person could not answer clearly, he/she may be recommended to refuse the inspection, saying, they will anyway come and make an unfavourable certificate, so why should they go for nothing?

If a person has applied for a licence and has been notified of the inspection scheduled, he/she must undergo it. If the license applicant refuses the pre-licensing inspection, the central body of the State Service of Ukraine on Medicines and Drugs Control will decide that the applicant has provided an unreliable information with all the ensuing consequences.

You may refuse the inspection only for good reasons. For example, due to health reasons. If the applicant refuses the inspection without good cause, it means that he/she is not ready for it. Consequently, the information that was declared in the statements was false.

Related article: Undergoing The Licensing Inspection

What to do in case of a negative result of the on-site pre-licensing inspection?

The final decision is made by the central body of the State Service of Ukraine on Medicines and Drugs Control. Of course, they make their decision based on the conclusion drawn up by local inspectors.

However, in certain cases, the commission may take the side of the license applicant, if it sees that the applicant generally meets the licensing requirements.

Related article: What To Do If The Pharmacy License Has Been Revoked?

If you want to start a pharmacy in Ukraine - we will help you make sure that your documents and premises fully meet the requirements and will get a license for you.

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