Drugs may be imported and administered for medical purposes in Ukraine upon their public registration only. After a successful registration procedure, a Registration Certificate is issued and remains valid and effective for five (5) years.
Public registration (re-registration) is performed by the Ministry of Health of Ukraine based on the results of drug expertise (expert examination) by the Public Pharmacological Centre under the Ministry of Health of Ukraine.
A drug public registration (re-registration) procedure begins with submission of the relevant Application to the Public Pharmacological Centre under the Ministry of Health of Ukraine by the applicant being a legal entity responsible for production, quality, safety and efficiency of a drug in question.
The Public Pharmacological Centre under the Ministry of Health of Ukraine performs the expert examination (expertise) of the relevant Registration File (Dossier), based on the results whereof the applicant is given remarks as to the contents and completeness of Registration File materials. Depending on the Registration File contents, remarks, promptness of responses to experts’ requests, and promptness of documents handling, processing and approval, the registration procedure may last from 7 months up to 2 years, until a Registration Certificate is obtained.
Official payments related to drug registration are paid by an applicant to the competent organizations based on bills received. Besides, additional costs and expenses appertaining to making necessary copies of documents, notarization of required Certificates, translation of documents into Russian and Ukrainian may arise. An applicant shall independently appear before competent expertise organizations, track registration related documents at every stage of expert examination (expertise), timely satisfy requests of such organizations in charge of expertise, and file documents in compliance with the currently effective applicable norms, rules and regulations. It should be noted that official documents and instruments governing the registration procedure are frequently changed, altered and amended, thus resulting in changed requirements of competent bodies and authorities.
Matrix employs highly qualified professionals willing to help you and skillfully consult you on the issues related to the drug public registration (re-registration) procedure.