You're reading: Health ministry to amend rules for registration of medicines registered in countries with tough regulatory policies

Ukraine’s Health Ministry initiates amendments to the rules of registration of medicines registered in countries with tough regulatory policies.

The draft ministry order has been posted on its website for public discussion.

The ministry seeks to remove the classification of changes from annex 5, as each country has own classification, which makes impossible changing the registration materials of medicines registered in some of the relevant countries.

According to the draft amendments, a legal entity or an individual that initiated the registration in countries with tough regulatory policies must not be an applicant.

The ministry wants to oblige applicants to present the endorsed copies of applications that were submitted in countries with tough regulatory policies. The guidelines for application of medicines submitted by the applicants must be signed by a translator.