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28.01.2025
THE EAEU HAS INTRODUCED A NEW PROCEDURE FOR REGISTERING MEDICINES AT THE INITIATIVE OF THE RESPONSIBLE AUTHORITY
A new option is provided for the registering of a drug at the initiative of the authorised agency of a EAEU member state.
The authorised agency will be entitled to register a drug if it and its analogues are not registered in this EAEU state, the state does not have an established procedure for registering such drug, and it is registered in a reference state. Written consent of the holder of the registration certificate will be required.
Recognition at the initiative of the authorised agency of the results of registration of a drug registered in the reference state will be carried out on the basis of the registration dossier data, the current version of the expert assessment report in the reference state, and also taking into account open publicly available information in the drug.
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