Draft Procedure For Conducting Expert Examination of the Scope of Registration Materials Elaborated by the Ministry of Health of Ukraine Has Been Made Available For Public Discussion

Pharmaceutical and medical law

The Ministry of Health of Ukraine has made available for public discussion the Procedure on expert evaluation in respect of the scope of materials attached to the application for state registration of certain medicines (hereinafter - "the Procedure").

As stipulated in the General Provisions of the aforementioned Procedure, it shall apply only to medicines used for treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncological and rare (orphan diseases) which are registered with the competent authorities of the USA, Switzerland, Japan, Australia, Canada or the EU.

Respectively, the Procedure provides for conducting the examination as follows. For the purposes of examining materials on medicines submitted for state registration the applicant shall furnish to the Ministry of Health of Ukraine the documents listed below (single-copy):

application for state registration of medicine intended exclusively for treatment of a certain disease;
materials, the scope of which shall be examined based on the list (as defined in the Addendum No.1 to the Procedure).

The Ministry of Health of Ukraine shall forward the copy of application along with all submitted materials to the State Enterprise "Expert Centre of the Ministry of Health of Ukraine" within one working day.

Upon receipt of documents the State Enterprise shall issue the invoice for payment for examination services as per the agreement concluded between the applicant and the SE "Expert Centre of the Ministry of Health of Ukraine". After that, within 4 working days the materials shall be examined as to their completeness and absence of discrepancies between information indicated in the application form and the scope of materials furnished for examination.

Based on the results of examination the SE "Expert Centre of the Ministry of Health" shall prepare conclusions which shall further be sent to the Ministry of Health within one working day since the date of issuance. The Ministry of Health of Ukraine shall, in turn, take a decision to grant state registration to the medicine subject to approval by the Order of the Ministry of Health of Ukraine or deny such request.

The Ministry of Health of Ukraine may deny state registration of the medicine on the following grounds:

submitting incomplete package of documents;
determining discrepancies between application and the scope of materials furnished for examination;
determining inaccuracy or incompleteness of information;
determining non-compliance of the medicine manufacturer's name, place of business and location of production facilities indicated in the application with the information relying on which such medicine was registered with the competent authority in the state of its origin.

The total period of examination carried out by the SE "Expert Centre of the Ministry of Health of Ukraine and registration of the medicine with the Ministry of Health of Ukraine shall constitute 8 working days.

Adoption of the Draft Law which was previously made available to the public shall facilitate provision of essential medicines to patients suffering from tuberculosis, HIV/AIDS, viral hepatitis, oncological and rare (orphan diseases).