Online Service For Issuing Pharmacy Licences: How Does It Work And What To Expect?

Since December 12, 2019 the State Service of Ukraine on Medicines and Drugs Control has introduced the test online service for obtaining several types of permit documents, namely:

  • Licenses to manufacture and import medicines;
  • Licenses for retail trade in medicines;
  • Licenses for wholesale trade in medicines.

This service can be used only by the applicants that have an electronic digital signature.

Will it be easier to obtain a Pharmacy License online? What can you expect from the new online service?

We have been providing legal support and assistance in obtaining Pharmacy Licenses for many years, so we can analyze any developments and help you make head of the situation.

Related article: Wholesale Trade In Pharmaceutical Products 

How can the new online service facilitate the process of obtaining a Pharmacy License?

This service is expected to help achieve the following objectives:

  • Reduce communication between business entities and employees of the State Service of Ukraine on Medicines and Drugs Control in order to level out the risks of corruption;
  • Save the license applicants’ time when submitting documents, including time spent for a trip to Kyiv;
  • Reduce the number of technical errors when filling out application forms and statements.

Let’s see how such service and system work in practice.

Related article: Call Button In Pharmacies

Legal analysis of potential problems that may arise when obtaining a Pharmacy License through the online service of the State Service of Ukraine on Medicines and Drugs Control

Analyzing the work of similar online services and software features of a particular service of the State Service of Ukraine on Medicines and Drugs Control, we can say that it really may save the applicants’ time.

And now let’s see what qualitative tips the system can offer, whether the risk of corruption really decreases and how it can affect your business. Let’s consider on an example of obtaining a license for retail trade in medicines.

Reduced communication with public officials

Let’s say a person intending to start a pharmacy has applied online. The inspection consisting of alive people - employees of the regional State Service of Ukraine on Medicines and Drugs Control, will visit the applicant not later than on the tenth business day (in practice - on the fourth-fifth day) following submission of documents.

Thus, communication with representatives of the state authorities is reduced by one person - the recipient of documents. But the decision depends on the inspectors - they decide where to “tick”.

Thus, the license applicant, as it has been so far, remains dependent on the results of the on-site inspection.

Of course, properly prepared documents by a lawyer, correctly designed premises and properly executed documents for them will help to ensure the success of the inspection. If you use services of a specialized lawyer for legal support of the inspection and assistance in the primary execution of documents, this will increase your chances for obtaining the license.

Related article: Examples Of License Inspections

Reduced number of technical errors

Online tips will help you to exactly know what information shall be indicated in this or that column. However, when obtaining the license, the applicants usually have a lot of questions not only of a technical nature:

  • How to properly employ a pharmacy director?
  • Do the documents of this or that candidate meet the requirements so that he/she can be appointed as an authorized person?
  • Do the premises fit for purpose of opening a pharmacy?

Unfortunately, this online service can’t analyze all these issues and do not provide any advices to the applicants. Only a lawyer can provide you with necessary recommendations based on your specific case and premises.

Related article: Pharmacy License Revocation

If your key objective is to achieve a positive result, to save your time and efforts, you should get a  qualified lawyer to run your case. A real business needs a real evaluation and experience in such cases.

Publication date: 03/02/2020

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Name: Marina Losenko

Position: Associate

Education: National Aviation University

Knowledge of languages: Russian, Ukrainian

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