Upharmacia July 2017
has signed a contract with Farmak
for 2.5 years. His primary aims on
his new role are to gain 15% of
the total market share of the local
market and to increase Farmak's
export by +54%.
Mr. Dubnicka has been working as
the CEO of Star Pharma Ltd and
divisional CEO/ Member of Board of
Sanofi S.A. broken cartridge holder may
result in the device delivering a
reduced dose of insulin which could
potentially lead to high blood sugar.
Novo Nordisk believes the risk of
experiencing high blood sugar when
using a device with an affected
cartridge holder is low.
N ovo N ordisk recalls B upivacaine -3N of Z dorovje
N arodu is
B anned to U se
D ue to a L ethal
C ase
cartridge holders in
certain I nsulin
P ens
Novo Nordisk is
initiating a recall of
insulin cartridge holders used in a
small number of NovoPen Echo ®
and NovoPen 5 ® batches because
they may crack or break if exposed
to certain chemicals, like certain
cleaning agents.
NovoPen Echo ® is used for insulin
treatment by people with diabetes.
Using a device with a cracked/
The recall is announced globally
including Ukraine.
The State Services of Ukraine on
Medicines and Drugs Control has
banned a series of Bupivacaine-3N
produced by Zdorovje Narodu due
to an officially recorded lethal case
after the usage of the product.
Zdorovje FF, Farmex Group, GNCLS
Pilot Plant, is a part of the Zdorovje
Group holding.
A rterium R ecalls a B atch of
C orvazan ®
The State
Service of Ukraine on Medicines and
Drugs Control published an official
ban on circulation and usage of
Corvazan ® produced by Arterium
due to the error on the package.
The whole batch of the series
No. 156226 has a discrepancy on
packages.
Corvazan ® is used in hypertension,
chronic angina, and as adjunctive
therapy in chronic heart failure
treatment.
Bupivacaine is used as a local
anaesthetic.
Zdorovje Narody, together with
REGULATORY UPDATES
T he M inistry of H ealth W ill
R egister the F irst D rug U nder
a S implified P rocedure
On July 20, 2017, the State Expert
Center of the Ministry of Health
of Ukraine presented a report on
approval of registration materials
for a medicinal product within
the framework of a simplified
procedure for registration of
innovative medicines from
countries with a severe regulatory
system, which has been posted
on the official website. Since the
introduction of this procedure (Dec
30, 2016), three applications for
registration have been submitted,
but only the latter has passed the
www.upharma-c.com
expertise of the State Expert Center.
Let us remind you that within
the shortened procedure, the
innovative drugs that have already
been registered by the competent
authority of the United States,
Switzerland, Japan, Australia,
Canada, as well as medicines that
are registered in a centralized
procedure by the competent EU
authority, can be registered for use
on territories of these countries or
EU member states within 17 days.
Now, most of the problems
that arise when assessing the
registration materials of the State
Expert Center, which are the basis
for registration rejection, are
Provided by
related to the following factors:
• The lack of an opportunity to
obtain clarification from the
applicant for particular data from
the registration materials and, as
a consequence, the need for the
SEC to reject applications in the
event of any material mismatch;
• The difficulty in verifying the
medicinal product registration
fact on the official websites of
regulatory authorities due to the
search difficulty on the sites of
different countries;
• Difficulty in confirming the
7