Legal & Regulatory > Slovakia > Localization

The legal framework for localization in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

There are generally not such rules. However, the handling with medicinal products (as defined by the Act on Medicinal Products), in particular the production of medicinal products and wholesale distribution of medicinal products and provision of pharmacy services, requires a special license for the respective activity issued under the Act on Medicinal Products e.g. the authorization for manufacturing of medicinal products issued by the State Institute for Drug Control is required for manufacturing of medicinal products. However, the State Institute for Drug Control recognizes the authorization for manufacturing of medicinal products issued by the respective authority of another EEA member state. The same applies to authorizations for wholesale of medicinal products issued by the respective authority of another EEA member state. The authorization for manufacturing of medicinal products issued by the State Institute for Drug Control is required also for import of medicinal products from non-EEA countries.

With respect to clinical trials, these also require the approval of the State Institute for Drug Control. Under the Act on Medicinal Products, the sponsor or its representative must have a residency (in case of an individual) or its registered seat (in case of a legal person) in an EU member state. Clinical trials can also be conducted abroad. If the clinical trial is performed outside the EEA, the applicant for the marketing approval must submit a declaration that the clinical trial performed outside the EEA meets the ethical requirements as required by the Act on Medicinal Products.

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

No.

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Foreign marketing authorizations are basically not valid in the Slovak Republic and authorization of local authorities (i.e., the State Institute for Drug Control) is required, except for the authorization issued by the European Commission through the centralized procedure which is then valid for all EEA member states.

Marketing authorization may be also received within the EEA following simplified procedures, i.e., the mutual recognition procedure (recognition of an existing national marketing authorization by one or more EEA member states) or the decentralized procedure (the application for marketing authorization is submitted simultaneously in several EEA member states). Still, a separate authorization issued by the State Institute for Drug Control is required. Further, the applicants for the marketing authorization must have their residency or registered seat in the Slovak Republic or in another EEA member state.

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the pricing process for pharmaceutical products in not impacted by localization policies in Slovakia.

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the reimbursement of pharmaceutical products in not impacted by localization policies in Slovakia.

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the access to public tenders in general is not impacted by localization policies in Slovakia.

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?

Import tariffs, importation and exportation permits are generally regulated on an EU level, without any complex local rules existing in Slovakia. The authorization for manufacturing of medicinal products issued by the State Institute for Drug Control is required for import of medicinal products from non-EEA countries. The State Institute for Drug Control is also involved in case of export of medicinal products (partially or fully) reimbursable from the public health insurance system from the Slovak Republic.

Slovakia offers certain attractive taxation schemes for companies involved in research and development. For example, Slovak tax law enables companies to apply for (an additional) tax base deduction of 200% of R&D costs incurred in the respective tax year. The tax base deduction may be further increased if the funding of R&D activities by the taxpayer intensifies over time.

Slovakia also offers a partial (50%) exemption on incomes from exploitation of IP/IT rights developed in the Slovak territory.

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

Slovakia in general offers investment incentives (through either direct subsidies or tax holidays), but without a specific focus on the pharmaceutical sector.

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

No such discussions are currently in place in Slovakia.