Important amendments to the EAEU legislative acts

Based on the results of the meeting of the EEC Working Group on Medicinal Products as of 05.10.2020 – 07.10.2020, the following important amendments to the EAEU legislative acts are planned to be introduced:

• extension of the transition period to allow manufacturing authorisation of medicinal products under the national legislation of the Member States until the 31st of December 2022;

• creation of a Union register for indicated groups of medicinal products, which mustn’t  be  updated according to EAEU requirements;

• allow QP to be located outside the Union.

Contact us for further information or if you are looking to develop regulatory strategy in this region:
info@smart-pharma.group