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  • Regulatory House

Submission of documents verified abroad for the purpose of reporting reimbursements for med. devices

Within the unification of the practice of the State Institute for Drug Control (SÚKL), there is a change in the requirements for the submitted Powers of Attorney for the needs of reimbursements reporting for medical devices.

From 1st August 2021 the procedure will be implemented in accordance with the Convention on Abolishing of the Requirement of Legalisation for Foreign Public Documents (Hague Apostille Convention). According to this Convention, it was stipulated that public documents issued in the territory of one state and which are to be presented in the territory of another state must be provided for these purposes with either apostille or superlegalization. Exceptions are countries that have concluded a bilateral agreement with the Czech Republic on exemption from verification.

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U kterých výrobků nelze žádat o registraci?

SÚKL na svých webových stránkách zveřejnil několik typů výrobků, u nichž již nelze žádat o registraci jakožto léčivého přípravku, jelikož nenaplňují definici dle §2 zákona č. 378/2007 Sb. o léčivech.


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