Prospects of establishment simplified registration of medicinal products

On 12.22.14 in the Verkhovna Rada was registered the draft # 1579 "On Amendments to Article 9 of the Law of Ukraine "On Medicinal Products" concerning simplification of state registration of medicinal products", which provides registration within 5 working days of medicinal products, registered and manufactured in Australia, Canada, USA, Switzerland, Japan, or produced in the state-members of the EU and registered by European Medicines Agency.

As of 26.12.14, the Healthcare Committee has sent a draft for improvement.

As noted by the Healthcare Committee of the Verkhovna Rada and the Main Scientific-and-expert office of the Verkhovna Rada, disadvantages of the document are as follows:

• The draft does not provide verification such medicinal products on compliance with GMP.
• The draft does not take into account the fact that in Australia, Canada, USA, Switzerland, Japan, the state-members of the European Union made a large number of medicinal products intended exclusively for export are produced. These products are not available for domestic markets and are not used in medical practice. Simplifying the registration procedure for all, without exception, medicinal products registered and produced in these countries Ukraine will create a legal basis for the import of medicinal products of dubious quality and security.
• The draft contains discriminatory provisions for products from various foreign countries: on what basis were chosen these very states and why other countries of the EU are not included to this list? The vast majority of state-members of the EU also apply high quality standards (e.g. Germany, France, etc.) and decentralized registration procedure in these state-members of the EU is not inferior to the procedures that exist in Australia, Canada, USA, Switzerland, Japan.
• The draft is flawed in legal technic, in particular inconsistency with the other provisions of the Law "On Medicinal Products", the draft does not conform to rule-making technology.

An alternative to this draft, discussed now by the participants of the pharmaceutical market, is the introduction of a simplified registration according the proposed model, however, for products from Australia, Canada, USA, Switzerland and Japan - only for original medicinal products.