License for general trade in medicinal products

Obtaining a drug retail license is a key step for any entrepreneur who wants to open a pharmacy or medical facility. This license is not only a mandatory requirement of the legislation but is also of great importance for ensuring the safety and efficiency of medical care for citizens.

If you want to obtain a license for the sale of medicinal products, contact the medical lawyers of the company “Prykhodko and Partners”, who will be able to provide you with legal support, regardless of the level of complexity of the situation.

What documents are required for the issuance of a license for the sale of medicines?

• Application for the issuance of a license;
• Reference from EDRPOU;
• A document that gives the right to use the premises where trade will be carried out;
• Technical documentation of the premises where trade will be carried out;
• A document certifying the manager’s specialization;
• A document on the existence of an employment relationship with the manager;
• A copy of the agreement with the postal operator regarding the delivery of medicines;
• Information about the availability of material and technical base;
• Information on the availability of specialized personnel;
• Copy of passport and TIN;
• 2 copies of the description of documents according to a special form.

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What is the procedure for obtaining a license for the sale of medicinal products?

You can apply for a license in 3 ways:

• online (through the electronic cabinet of the State Medical Service);
• in person (by submitting relevant documents to the SSU for medicinal products and drug control);
• through postal means (by submitting relevant documents to the official address of the State Medical Service).

It should be noted that if the documents are not prepared correctly, the application will not be considered. Also, if false information is found in the submitted documents, the license will be refused, and a new application can be submitted only after 3 months.

Importantly! A positive decision on the issuance of a license enters into force and is published on the website of the State Service of Ukraine for Medicinal Products and Drug Control. The licensee can carry out retail trade of medicines on the next working day after the adoption of a positive decision by the civil service.

What is the term of consideration of documents for the issuance of a license?

The review of the application and documents is carried out within ten working days from the moment of submission to the licensing authority.

The license for the retail trade of medicinal products has no limitation on the period of validity.

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How can we help?

The lawyer of the company “Prykhodko and partners” can provide comprehensive legal assistance in obtaining a license for the retail trade of medicinal products. Here are the main aspects in which a lawyer can be helpful:

• Consultations and analysis of license requirements, analysis of documents required to obtain a license.
• Preparation of a package of documents that must be submitted to the relevant authorities.
• Representation of the client’s interests in licensing bodies, and interaction with state bodies at all stages of the licensing process.
• Appealing the decisions of the Ministry of Health in case of refusal to issue a license or other unfavorable decisions.

Contacting the lawyers of the company “Prykhodko and partners” will provide legal support at all stages of obtaining a license for the sale of medicinal products, which will significantly reduce risks and simplify the process. For consultation, fill out the form below.