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Classification of medicinal products

The State Agency of Medicines classifies the medicinal products upon grant of or renewal of a marketing authorisation for a medicinal product or upon occurrence of circumstances prompting a change of classification of and grant of a permit of use of a proprietary medicinal product.

For the change in classification of the medicinal products the application has to be submitted according to the regulation of Ministry of Social Affairs.

The classification change is not considered as variation according to the EC Regulation No 1234/2008. However, in case the product information needs to be changed due to the change in classification (e.g. indication) these variations have to be submitted separately.

The application can be submitted electronically via CESP or e-mail/Eudralink to [email protected]

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Last updated: 25.11.2021