Upharmacia January 2017 (Special Edition) | Page 14

Upharmacia January 2017
pharmacovigilance system,
without which circulation of
medicinal products, vaccines
and tuberculin is not permitted
in Ukraine.
Thus, the applicant must
establish and manage at least
one pharmacovigilance system,
which consists of elements
allowing for the monitoring of
safety of medicinal products,
vaccines and tuberculin and
determining any changes in
benefit / risk ratio, namely:
i. that the applicant
(permanently and continuously)
has at least one qualified
authorized person responsible
for pharmacovigilance.
Depending on whether the
applicant is in Ukraine or not,
the authorized person must
be either an employee of the
applicant (for applicants who
are residents), or a contact
person should be designated
on the territory of Ukraine
and be subordinated to the
applicant’s authorized person
(for non-resident applicants).
These persons must have higher
medical or pharmaceutical
education (pharmacist, clinical
pharmacist);
into pharmacovigilance by
entering into contractual
relationships;
vi. providing training of
personnel of the applicant to
carry out activities related to
pharmacovigilance;
vii. creation of pharmacovigi-
lance quality system;
viii. pharmacovigilance
documentation processing,
including its storage and
archiving;
ix. creation and support of the
risk management system.
ii. a structured system of
organization of pharmacovigi-
lance, its update and support;
iii. documentation of all
procedure processes;
iv. creation and maintenance of
databases used by the applicant
for pharmacovigilance;
v. involvement (if needed) of
other legal and / or natural
persons and enterprises,
institutions and organizations
14
www.upharma-c.com