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Health Care

24/ 10/ 2016

On 20 October 2016 the Ministry of Health of Ukraine (MoH) published on its website the explanation as regards the free exchange of the registration certificates of medicines that were renewed in Ukraine for an unlimited period.

Several months have passed since companies started to get their unlimited registration certificates (albeit of the old format, i.e. valid for five years). In addition, the information indicated in the registration certificates often contained inconsistencies inside the same registration certificate. Also, the certificates didn’t coincide with the information in the State Register of Medicines. This happened because the new registration certificate format to demonstrate registration of a medicine for an unlimited period remained unapproved.

Several steps were implemented to get a full and lasting solution to the problem. First of all, due to the proactive actions of the management of the State Enterprise “The State Expert Center of the Ministry of Health of Ukraine” and the MoH, the temporary registration certificate format was adopted. Then MoH Order No.773, which adopted the new format for the unlimited term registration certificates, was adopted. Now the explanation has been published as regards the exchange of the old registration certificates with the new ones.

The European Bussiness Association welcomes the implemented steps and expresses its gratitude to MoH for the explanation of utmost importance and significance published for the pharmaceutical business community’s knowledge.We hope that there will be no technical problems faced by companies at starting to practice the exchange of their registration certificates.

Legal background:

On 30 October 2015 the MoH Order “On Amending the Procedure for Expert Evaluation of Drugs’ Registration Materials Submitted for State Registration (Renewal) and Variations” No.460 dated 23 July 2015 was adopted to allow applicants to submit applications for the unlimited renewal of drugs under the new procedure came into force.

On 16 September 2016 the MoH Order “On Amendments to the MoH Order No.358 dated 29 July 2003” No.773 dated 27 July 2016 (MoH Order No.773) came into force to start using the new form of the registration certificate for an unlimited period.

20 October 2016 the explanation on the free-of-charge exchange of registration certificates was published on the MoH’s website to start the procedure of exchanging old-format registration certificates with the new ones. The exchange is free-of-charge upon written request of an applicant within the period specified in the certificate (5 years).

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