Open a Pharmaceutical Company in Slovakia

Updated on Tuesday 28th February 2017

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open-a-pharmaceutical-company-in-slovakia.jpgSlovakia has a market size similar to Hungary or Spain when it comes to per capita numbers. The country complies with the international approval requirements and has a tradition regarding the medical equipment manufacturing. This state is considered one of the most advanced health device and pharmaceutical markets in Central and Eastern Europe areas. Our company formation advisors can offer more details regarding the pharmaceutical industry in Slovakia
 
In order to open a pharmaceutical company in Slovakia, the business has to be authorized by the State Institute for Drug Control (SIDC), which is a state authority in the human pharmacy and drug precursors sectors. The SIDC in Slovakia is run by a director, who is named by the Minister of Health in Slovakia.
 

Registration of a human drug in Slovakia

 
When opening a pharmaceutical company in Slovakia with the intent of producing a human drug, the organization has to undergo an authorization procedure of the input to the market and its insertion to the list of authorized medical goods with the SIDC. 
 
This authorization procedure can be effectuated locally or internationally, and it is comprised of several activities. These activities may include profit and application assessment, etc.
 

Registering a Slovak pharma company with the SDIC

A Slovak pharmaceutical company must register (obtain the approval) with the SIDC, which will:
 
issue the marketing authorization and the obtainability of effective and safe medical products;
effectuate controls and standardized laboratory activities to assess the quality, effectiveness and safety of medicines;
prepare and makes public the Slovak Pharmaceutical Codex;
process the applications for clinical trials and approves them;
control and evaluat the quality, safety and efficacy of medical products;
gather, analyze and monitor possible adverse reactions;
other responsibilities. Our Slovak company formation professionals can provide further information on what these other responsibilities consist of.
 
If you need to know more about how to open a pharmaceutical company in Slovakia, please contact our Slovakia company formation specialists.

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