Authorisation for the production of medicinal products

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Authorisation for the production of medicinal products

Any natural person or legal entity may handle medicinal products and medical devices only on the basis of a permit issued pursuant to Act No. 362/2011 Coll. on Medicinal Products and Medical Devices and on Amendment and Supplementation of Certain Acts (hereinafter referred to as the “Act on Medicinal Products and Medical Devices”).

Under the Act on Medicinal Products and Medical Devices, it is possible to obtain a permit for the handling of medicinal products on the basis of an applicant's application to the State Institute for Drug Control for the following types of activities:

  1. production of human medicinal products
  2. production of tested human products and tested human medicinal products
  3. wholesale distribution of human medicinal products
€1,100.00
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The price is stated without VAT and may be increased depending on the scope of the work performed and the type of permit.

Initial consultation

  • Initial consultation and advice regarding the assessment of the possibilities of operating a healthcare facility, the assessment of the performance of the medical profession, the assessment of the need to obtain a license for the operation of an independent medical practice for a healthcare facility professional representative.
  • Legal assessment of the material and spatial equipment and staffing of a healthcare facility and the preparation of the relevant documentation.
  • Legal assessment of the correctness of existing papers and documents.

Conception and submission of an application for the issuance of a permit

  • Preparation and submission of a written application for the issuance of a specific permit to the competent authority.
  • Preparation and provision of all mandatory and optional attachments and requirements of the application for the issuance of a permit.
  • Providing comprehensive legal advice on all attachments and requirements of the application for the issuance of a permit (e.g., relating to the real estate in which the activity is to be carried out or relating to the area of labour law in relation to a professional representative or other persons).
  • Representation in all legal actions and communication in relation to the competent authorities (Ministry of Health of the Slovak Republic, Healthcare Surveillance Authority, competent self-governing region, municipality, competent regional public health authority, etc.).

Legal actions in the process of deciding on an application for the issuance of a permit

  • Supplementing the required supporting documents and supplementing the application, removal of deficiencies.
  • Demanding the decision on the issuance of a permit.
  • Subsequent provision of a notification of changes in the permit or the issuance of a new permit.

Our goal is to benefit the client

Choosing the right and reliable advisor is always a great help in improving yourself. Above all, consulting in the field of law is extremely broad-spectrum and affects almost all areas of the life of entrepreneurs and individuals, therefore the choice of a legal advisor is extremely important. In the law office Hronček & Partners, s. r. o. we pay attention to professionalism and high quality legal services with an individual approach. Our main goal is to provide legal services of the highest quality and to bring innovative and professional solutions for the client so that we become their trusted partner.

Hronček & Partners, s. r. o.
Smart legal services

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More services in the field of healthcare (permits / licences)

Authorisation for wholesale distribution of medicinal products

€1,100.00
The price is stated without VAT and may be increased depending on the scope of the work performed and the type of permit.
More information

An application for the issuance of a permit for wholesale distribution of human medicinal products is submitted by the applicant to the State Institute for Drug Control

Permit for the provision of pharmacy care in a public pharmacy

€1,100.00
The price is stated without VAT and may be increased depending on the scope of the work performed and the type of permit.
More information

Permits for the provision of pharmacy care in a public pharmacy are submitted by the applicant to the relevant self-governing region.

Other types of permits in the field of handling medicines and medical devices

On demand
The price depends on the scope of work performed and the type of permit.
More information

A permit to operate an outpatient healthcare facility

€1,100.00
The price is stated without VAT and may be increased depending on the scope of the work performed and the type of permit.
More information

The permit to operate an outpatient healthcare facility is issued by the relevant self-governing region.

Permits to operate a general hospital

€2,000.00
The price is stated without VAT and may be increased depending on the scope of the work performed and the type of permit.
More information

The permit to operate a general hospital is issued by the relevant self-governing region.

Permits to operate a mobile collection point

€1,100.00
The price is stated without VAT and may be increased depending on the scope of the work performed and the type of permit.
More information

An application for the issuance of a permit to operate a mobile collection point is submitted by the applicant for the operation of a mobile collection point to the Regional Public Health Authority.

A permit to operate another healthcare facility

On demand
The price depends on the scope of work performed and the type of permit.
More information

Permits for the operation of various types of medical facilities are issued by the Ministry of Health of the Slovak Republic, the relevant self-governing region or the Health Care Supervision Office according to the type of permit.

We would like to express our satisfaction and gratitude for the excellent cooperation with the Hronček & Partners law firm in connection with the preparation of the contract for Všeobecná zdravotná poisťovňa, a.s. Cooperation with their team of lawyers was not only professional, but also pleasant. We were impressed with their expertise, thoroughness and commitment at every step of the process. Their ability to analyze and interpret complex legal issues gave us confidence that we were in good hands. In addition to being professional, they were also very approachable and willing to answer our questions and provide us with explanations. The result of their work was an exceptional contract that exactly fit our needs and helped us achieve our goals.

We recommend the law firm Hronček & Partners with 100% confidence in the field of legal services in the health sector. With their help, we obtained quality legal support. We thank the entire Hronček & Partners team for their excellent work and highly recommend their services to anyone looking for professional and reliable legal assistance.

Ing. Jiří Pecina, MBA
CEO, MEDDI hub s. r. o.
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