Ukraine - Proposed Draft Law of Ukraine "On Amendments to the Law of Ukraine "On Medical Products "Regarding a Holder of the Registration Certificate"
Business description
Ministry of Health of Ukraine proposed Draft Law of Ukraine "On Amendments to the Law of Ukraine "On Medical Products "Regarding a Holder of the Registration Certificate":
- establishes clear requirements for a holder of the registration certificate in terms of ensuring the quality, safety and efficacy of a medical product registered in Ukraine;
- elimination of legal conflicts between normative-legal acts of the legislation of Ukraine in the sphere of circulation of medicines;
- creation of a legislative field adapted to the legislation of the European Union, which regulates the legal status of a holder of the registration certificate for a medicinal product registered in Ukraine, including one imported into the territory of Ukraine;
- prevention of unjustified shortage of medicines on the territory of Ukraine.
After the adoption of the draft Law and its entry into force, the holders of valid registration certificates for medicinal products must make appropriate changes to the materials of registration dossiers by January 1, 2022.
Proposed date of adoption : To be determined
Proposed date of entry into force : The day following the day of its publication
Final date for comments : Apr. 13, 2021
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