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)?
Registration in a reference state will involve filing the registration dossier and samples of medicine, examination of documents, laboratory trials and, if necessary, inspection of manufacturing, pharmacovigilance, pre-clinical and clinical trials. Recognition in a recognition state will involve filing the registration dossier and studying the examination report prepared by the reference state.
- What will be the term of marketing authorization?
Marketing authorization will initially be issued for five years and then, after successful re-registration, for an indefinite period. The five-year term starts from registration in the reference state.
- How will EEU re-registration work?
Before expiry of the five-year registration term, the authorization holder applies for re-registration in all member states where the medicine is registered. Re-registration is based on risk-benefit assessment of the medicine by the reference state. If the outcome is positive, an indefinite marketing authorization is issued.
- Is there a transition period, ie, when old registration procedures still apply?
Yes. The applicant may choose which procedure to apply – EEU or national – within the next five years (until 31 December 2020). If the national procedure is chosen, the applicant must nevertheless ensure compliance of the medicine with EEU requirements within the next ten years (until 31 December 2025).
- What will happen to medicine already registered?
Within next ten years (until 31 December 2025) the authorization holder should adjust the registration dossier of medicine already registered. The adjustment procedure does not involve risk-benefit assessment unless the holder wishes to extend registration to member-state(s) where the medicine was not registered. Before the registration dossier is adjusted, re-registration is performed under the national procedure.