State Institute for Drug Control

No, but they must be documented for all batches of medicinal products intended for distribution in the Czech Republic or other EU and EEA countries which were delivered to the Czech Republic from another Member State. Before the commencement of distribution of such medicines the distributor must verify that a certificate or another document declaring the release of a batch by a medicinal product manufacturer signed by a qualified person in accordance with Art. 51 of Directive 2001/83 / EC was issued and have the relevant document or its copy at disposal.