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Slovakia

European Bolar Provisions in Slovakia

Table of contents
  1.  How is Bolar implemented?
  2.  How does the Bolar provision work?
  3.  Is Bolar restricted to exempting studies for generic marketing authorisations?
  4.  Has Bolar been litigated in your jurisdiction?
  5.  Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 
  6.  Does Bolar extend to a third party who assists the MAH in carrying out the activities? 
Slovakia
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1. How is Bolar implemented?

Bolar exemption is implemented in Article 49 of Act No. 362/2011 Coll. on Medicines and Medical Devices and on Amendments to Certain Acts as amended (hereinafter as “Act”).

2. How does the Bolar provision work?

According to Article 49 par. 8 of the Act conducting of toxicological-pharmacological testing and clinical testing  and replacement of results of the testing with results of the testing of a reference medicinal product is not regarded as violation of patent rights or supplementary protection certificates.

3. Is Bolar restricted to exempting studies for generic marketing authorisations?

In Slovakia, Bolar is implemented as a broader exemption not only for acts required for marketing approval but also for acts relating to innovative medicines.

4. Has Bolar been litigated in your jurisdiction?

We are not aware about any significant litigation related to Bolar exemption.

5. Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 

For Bolar to apply the Act presumes that regulatory approval will be sought in Slovakia.

6. Does Bolar extend to a third party who assists the MAH in carrying out the activities? 

Slovak Act does not expressly mention the right to extend Bolar to a third party who is assisting the MAH.