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Vereenvoudiging registratie van farmaceutische producten in Oekraïne

Hieronder vindt u meer informatie over het wetsvoorstel i.v.m. de vereenvoudiging van de registratie van farmaceutische producten in Oekraïne:

Policy Progress: State Registration of Medicinal Products - Simplified by Adopted Draft Law #4484

On May 31, Verkhovna Rada of Ukraine adopted Draft Law #4484 "On Amendments to Article 9 of the Law of Ukraine "On Medicinal Products" on Simplification of State Registration of Medicinal Products." To make it happen, the Chamber continuously supported and advocated the facilitation of registration of medicinal products as an effective tool for access to medicinal products and development of healthcare investment environment in general, in particular by exceptionally active engagement in law development process.

The simplification of state registration procedure from countries with strict regulatory policy is one of the important tasks of the healthcare system of Ukraine, effective implementation of which guarantees the early access of patients to vital treatment. These countries, in particular are the following: USA, Canada, Switzerland, Japan, Australia. Also simplified scheme will apply to medicinal products that are registered by the European Medicines Agency (EMA) under the centralized procedure - that is the strictest procedure of registration of medicinal products in the EU. Thus, medicinal products that authorized in all 28 states will find their way to the market of Ukraine.

Now are looking forward to signing of the respective Law by the President of Ukraine, and will take all necessary efforts to make it happen.

Contact person - Maxim Proskurov, Policy Officer (Healthcare Issues) mproskurov@chamber.ua

6 juni 2016