The Council of the Eurasian Economic Commission (EEC) has amended the rules for registration and expert examination of medicinal products for human use in the Eurasian Economic Union.
In particular, it adopted common approaches to the procedure for changing the registration documents for flu prevention vaccines.
“This is a special group of medicinal products, which is modified once a year due to the changes of disease virus. The decision established common requirements to the structure, content, format, and volume of registration dossier, procedures for making changes to the dossier, its expert examination, as well as the period of reviewing the applications for registration. Current requirements to the development of vaccines and public vaccination to prevent flu epidemics and pandemics do not allow to apply the standard procedure period of 210 days to the registration of these drugs and introduction of changes. This is why it was decided to introduce an expedited procedure for assessing this group of vaccines when making changes to the registration dossier related to the changes in the flu strain. The duration of the procedure for introducing changes to the registration dossier should not exceed 40 calendar days. This will allow to implement annual vaccination in a timely manner and preserve the health of millions of people,” announced the press service of EEC.
In addition, the deadline for submission of documents confirming the compliance of manufacture with the requirements of good manufacturing practice and issued to the manufacturers of medicinal product by the relevant authorities of EAEU member states was extended for two years until December 31, 2020.
“The decision was caused by peculiarities of emerging common market of medicines and will allow pharmaceutical manufacturers to use national certificates until they expire without the need for early re-registration,” said the press service. “This will ensure a smooth transition from national documents confirming the compliance of manufacturing with the requirements of good manufacturing practice issued before 2017 and valid up to 2020 to the unified documents of the Union. The adopted decision will help drug manufacturers to adapt to new requirements as comfortably as possible.”