February 2016 is expected to see the launch of a single market of medicines in the framework of the Eurasian Economic Union, which may be a game changer in the industry. Currently over 30 draft acts have been adopted, establishing EEU rules and principles for movement of medicines and covering such issues as registration, clinical trials, inspections, pharmacovigilance, and information exchange.
One of the key features of the single market will be EEU registration procedure, envisaging validity of marketing authorization throughout the EEU. Below is a brief Q&A overview of the EEU registration procedure, based on available draft acts.
Will a supranational registration authority be created, like the FDA or EC?
No, at least for now creation of a supranational registration authority is not envisaged. Registration will remain the domain of the national registration authorities.
How will EEU registration work?
The applicant may choose between two EEU registration procedures – the consecutive procedure and the simultaneous procedure. Under both procedures the applicant chooses a reference state, where registration activities will mostly be performed, and a recognition state(s), where registration activities will be rather limited.
What is the difference between consecutive and simultaneous procedures?
Under the consecutive procedure, registration is performed in a reference state and then recognition of registration is performed in other member-state(s). Under the simultaneous procedure, registration in a reference state and recognition in other member-state(s) are performed simultaneously.
- What will happen in reference state and recognition state(s)?
- What will be the term of marketing authorization?
- How will EEU re-registration work?
- Is there a transition period, ie, when old registration procedures still apply?
- What will happen to medicine already registered?