License for the production of medicinal products

A license for the production of medicinal products is one of the most important documents for pharmaceutical enterprises. It ensures that the company complies with all regulatory requirements and standards established by law. For drug manufacturers, this is not only a question of responsibility to patients, but also a necessary condition for legal activity on the market.

The legal company "Prykhodko and Partners" specializes in legal support for obtaining licenses, helping clients to successfully go through all stages of this complex process, from the preparation of documentation to interaction with licensing authorities.

What are the types of production of medicinal products and what documents are required?

Industrial production of medicines

Documents for obtaining a license:

1. Application for the issuance of a license;
2. Extract from EDRPOU/ Certificate of State Registration;
3. Documents confirming the right to use the premises;
4. Technical passport of the premises;
5. Bank details;
6. Scheme of the premises that will be used for the industrial production of medicines;
7. Information on responsible persons, laboratories and manufacturers of medicinal products;
8. Materials of the production site, which are approved by the manager of the legal entity;
9. Documents on the appointment of a pharmacy manager;
10. Description of documents in 2 copies.

Consult a lawyer

Production of medicines through a pharmacy

Documents for obtaining a license:

1. Application for the issuance of a license;
2. Extract from EDRPOU / Certificate of State Registration;
3. Documents confirming the right to use the premises;
4. Technical passport of the premises;
5. Documentation confirming the establishment of the pharmacy, work schedule, and number of employees;
   TIN;
6. Documents on the education of the pharmacy manager;
7. Documents on the appointment of a pharmacy manager;
8. Technical documentation for ventilation;
9. Passport documents for hydrometer and thermometer;
10. Description of documents in 2 copies.

Conditions for issuing a license for the manufacture of medicines

The recipient of a license for the manufacture of medicinal products can be:

• виробництво в умовах аптеки – юридична особа або ФОП.
• промислове виробництво – тільки юридична особа.

Submission of documents for obtaining a license for the manufacture of medicines is carried out:

• personally or through an authorized person;
• sending a package of documents by mail;
• sending a package of documents by e-mail.

The body that issues licenses for the production of medicinal products is the State Service of Ukraine for medicinal products and Drug Control. It takes ten working days to review documents and make a decision on issuing a license. The validity period of the license is unlimited.

Importantly! The grounds for refusal to issue a license may be the absence of an application in the prescribed format, an incomplete package of documents or the specified false information.

Consult a lawyer

Legal assistance in obtaining a license for the production of medicinal products

The legal company "Prykhodko and partners" provides comprehensive legal assistance in obtaining a license for the manufacture of medicinal products:

1. Professional consultation of a lawyer and legal analysis of documents.
2. Preparation of a package of documents for obtaining a license for the production of medicinal products with the resolution of problematic issues.
3. Submission and legal support at the State Medical Service.
4. Obtaining a license document.
5. Appealing the refusal to issue a license through the Expert Licensing Appeal Board or through a court.

The preparation of documents and the process of obtaining a license requires a lot of time and specialized knowledge, so it can be quite complicated and confusing. In order to do everything right and issue license documents the first time, we advise you to contact the medical lawyers of the company "Prykhodko and Partners". To calculate the cost of services for obtaining a license for the production of medicinal products, leave an application below.