As we reported in our previous alert, the Cabinet of Ministers of Ukraine has recently adopted Resolution No. 312 simplifying the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or Canada (the Strict Regulation Countries). Now, with the decision of the parliament on 31 May, even more drastic changes have been passed into law which is expected to come into force within the next few weeks.
Legislative developments are two-fold: those affecting medicinal products marketed in the Strict Regulation Countries, and those affecting all medicinal products.
The first group includes the following changes:
- The applicant should submit a limited number of documents if compared with the current standard application, namely: description of quality control methods, registration dossier, a mock-up of the outer packaging and package leaflet, and confirmation of paid registration fee.
- The law cancels mandatory expert examination of the registration materials, which currently is a pre-requisite for the state registration. Instead, the State Expert Center (the Center) will only review completeness and accuracy of the submitted information. However, the procedure for such review is yet to be developed and approved by the Ministry of Health of Ukraine (MoH).
- The maximum review period of the registration materials by the Center has been shortened to ten business days.
- The period for the adoption by MoH of its decision authorizing or refusing the registration of medicinal products has been shortened from one month to seven business days.
- Instead of the document evidencing the conformity of drug’s manufacturing conditions with those established in Ukraine, the applicant may choose to submit manufacturer’s written commitment to manufacture the medicinal product for Ukraine at the production facilities intended for manufacturing of the products to be used in the Strict Regulation Countries.
The second group includes inter alia the following changes that apply to all medicinal products:
- The period for adoption of the decision on state registration has been shortened from one month to ten business days.
- Information on submitted applications, their status and decisions taken shall be published on the website of the Center with free access.
Now, in order to ensure positive effect from the adopted law, it is essential that the respective bylaws reflecting outlined changes are developed and implemented without delay.