EBA is glad to inform that the amendments made by the MOH Order 773 dated 27 July 2016 which finally adopted the new registration certificate format for medicines are supposed to be soon published in an official bulletin to come into force. Natalia Serhienko, EBA Health Care Committee Executive Director commented the situation as follows:
“The MOH Order wasn’t adopted timely but it is good anyway, that it is finally adopted. The companies which passed through the new renewal procedure started to get the unlimited registration certificates for their medicines as far back as June-July 2016. At the same time, they were confused to get them with inconsistencies of information both inside and in comparison with the information indicated in the State Register of Medicines. At that point of time there were no public information to clarify the situation for the professional community, nor as regards the prospects of the necessary MOH Order adoption.
However, it should be admitted that the current management of the Ministry of Health of Ukraine and the State Expert Center did its best to avoid possible problems due to the delay with the MOH Order adoption. The temporary registration certificate format was adopted and this information was reported to the knowledge of the EBA Health Care Committee members, specifically.
Simultaneously, the amended registration certificate format contains new lines. It is not entirely clear what was the goal for inclusion of certain lines to the registration certificate because the registration certificates of the EU format (marketing authorizations) doesn’t contain such information. Surely, we’ll ask for explanations.
Currently, we expect that the official publication of the MOH Order will not be delayed anymore.”
More details you may find here: http://www.apteka.ua/article/384661