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Shortcomings of simplified registration lead to refusals of registration, exit from market of some registered medicines – EBA
KYIV. Feb 17 (Interfax-Ukraine) – Shortcomings of the simplified registration procedure lead to massive refusals in registration and withdrawal from the market of a number of previously registered medicines, according to the European Business Association (EBA).
“The simplified registration procedure, approved at one time by order No. 1245 of the Ministry of Health in pursuance of the relevant norm of the law, has certain procedural shortcomings, and was also not perfect before. These shortcomings could not be completely leveled when it was adopted in 2016. The main purpose of its implementation was to provide simplifications in drug registration for quick access of patients to treatment with drugs that are already approved for use in the EU and other countries with a strict regulatory system, but were not available in Ukraine. Unfortunately, now these shortcomings of the procedure lead to massive refusals not only in the new registration of these drugs, but also in the implementation of changes in the registration materials of existing registrations,” the EBA commented to Interfax-Ukraine.
The association noted that at the time of adoption, the corresponding simplifications were “progress for the pharmaceutical sector in Ukraine and new names of medicines needed by patients could enter its market.”
At the same time, the EBA emphasizes that the existing shortcomings of the procedure lead to the fact that “drugs that are already registered under this procedure may suddenly disappear from the market again.”
“We ask the Ministry of Health to prevent this and leave the possibility of updating the registration data of the drug that has already been registered under this procedure earlier in order to make it possible to make changes to the current registration certificates,” the EBA said.
The association recalled that the EBA Health Committee, when developing a new law of Ukraine on medicines, proposed a transition from this simplified procedure to more stable European accelerated registration mechanisms.
However, the new law on medicines has not yet entered into force in terms of these provisions, “therefore, today there is no other procedure that would provide simplified registration of medicines from the EU and countries with a strict regulatory system.”
