Snapshot

The Authenticity Procedure pathway has been developed by the State Service of Ukraine on Medicines and Drugs Control (SMDC) of Ukraine.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The duration of the procedure for registration under "authenticity" procedure is 5 working days. This period does not include: the period of consideration of the Application and the registration form; payment of the government levy and receiving the payment confirmation; final actions after expert evaluation (verification/proofreading of drafts of the registration certificate and its addenda); the period of signing the Order of the MOH on the registration of the medicinal product. The above actions take an average of 1 to 2 months, and accordingly extend the resulting period for registration.