On June 16, 2016, the President of Ukraine signed the Amendments to the Medicines Act, which are intended to simplify the procedure of state registration of medicines coming from countries with strong established regulatory requirements, institutions, and procedures. The changes will become effective starting from their official publication day and responsible government agencies must still adjust certain bylaws to implement them.
Extended list of medicines subject to the simplified procedure
Now all medicines (drugs) registered by a competent authority of the USA (i.e., FDA), Switzerland, Canada, Australia, Japan, and the EU are now subject to the simplified registration procedure. Whereas the previous version of the Medicines Act allowed such simplified procedures only for medicines that treat tuberculosis, HIV/AIDS, viral hepatitis, oncological, and rare (orphan) illnesses.
At the same time, medicines registered in other countries remain subject to the ordinary registration procedure.
Who may apply for registration under simplified procedure?
An applicant and registration holder of the medicines may be a legal entity or individual responsible for the effectiveness, safety, quality of a medicine, as well as for the reliability of information indicated in the application materials, and who ensures pharmacy supervision in Ukraine.
Pharma companies may now get a quick access to the Ukrainian market if they have their medicines properly registered in the USA, Switzerland, Canada, Australia, Japan, and the EU
Shortened list of documents
Under the simplified procedure, the applicant shall submit to the Ministry of Health Protection of Ukraine (the “Ministry”) only the following documents:
materials on quality control methods;
registration dossier materials;
package samples with marking;
application instructions;
payment receipt regarding the processing fee;
a copy of the document certifying manufacturing conditions correspond to those applicable in Ukraine or a manufacturer’s written guarantee that the medicine to be supplied to Ukraine is manufactured on the same facilities that are used to manufacture medicines supplied to the USA, Switzerland, Canada, Australia, Japan, and the EU.
Clinical trials and examination of documents no longer required
The most significant change is that new products registered in those developed countries and intended to be launched on the Ukrainian market will not be subject to pre-clinical and clinical trials in Ukraine prior to their registration.
In addition, the Ministry will no longer examine documents submitted for registration of the above medicines. In order to take a decision on registration (refusal), the Ministry will only review such documents (with regard to their adequacy, completeness, and formal requirements).
Shortened term of registration
The Ministry must take a decision to register a medicine or to refuse the application within 10 business days, instead of one month under the previous legislation. As regards medicines registered in above countries, the processing time shall not exceed seven business days.
More transparency
Finally, information on registration applications, current stage of processing and consideration results shall be published free of charge on the website of the State Expect Center of the Ministry (http://www.dec.gov.ua/).
Implications
Undoubtedly, the changes will have a strong positive impact on the local pharmaceutical market in Ukraine. They abolish the excessive clinical trial procedures for medicines which safety and effectiveness is attested by recognized international laboratories and controlling agencies of the leading industrial countries.
Pharmaceutical companies around the world may now get a quick access to the Ukrainian market if they have their medicines properly registered in the USA, Switzerland, Canada, Australia, Japan, and the EU. This is expected to facilitate import of high-quality medicines, increase competition and lower the price for consumers.