Upharmacia April 2017
skin under a diaper. The drug
is currently in the registration
process.
“Our company enters the new
segment – pediatrics, which we
see as prospective for further
development,” the Director of
Pharma Start stated. “In future,
we plan to expand our product
portfolio through cooperation
with Laboratoires Gilbert and
other companies”.
Acino-Pharma Start was 20th
company on the Ukrainian retail
drug market in 2016, climbing 2
positions vs 2015.
B iofarma is to
invest USD
55 mio in
development and production
The President of Ukrainian
company Biofarma Konstantin
Efimenko stated that in the
next 5 years, the company
will invest USD 40 mio in
the construction of the new
workshop for the production of
blood preparations. Moreover,
USD 5 mio will be invested
in development of new
preparations. Biofarma also
plans to spend USD 10 mio in
the construction of stations for
collecting blood plasma.
Implementation of the projects
will allow the company to cover
100% of Ukraine’s needs in
Coagulation factors VIII and IX.
The rest will be exported.
Biofarma is the only producer
of blood preparations in
the CIS, which produces
above 20 immunobiologi-
cal preparations from donor
blood. In 2016, the company
exported its production in
Belarus, Azerbaijan, Mongolia,
Kazakhstan and Vietnam.
Currently, the company plans
to enter the markets of
Philippines, Bolivia, Indonesia
and India.
REGULATORY UPDATES
T he N ew D raft of the
P rocedure for S tate C ontrol
O ver Q uality of M edicinal
P roducts I mported to U kraine
P roposed
On Mar 30, 2017, the State
Administration on Medicines
and Drugs Control of Ukraine
on its official website posted the
Draft Resolution of the Cabinet
of Ministers of Ukraine “On
Amendments to the Procedure
for State Control over Quality
of Medicinal Products Imported
to Ukraine” (hereinafter - the
“Draft”). The Draft proposed a
new wording of the Procedure
for State Control over Quality of
Medicinal Products Imported to
Ukraine approved by Resolution
of the Cabinet of Ministers
of Ukraine No. 902 as of Mar
www.upharma-c.com
14th, 2005 (hereafter – the
“Procedure”).
The following are significant
differences between the Draft
and still effective Procedure:
1. The Procedure will govern
relations in the area of state
quality control of medical im-
munobiological drugs used,
produced or offered for use in
medical practice in Ukraine.
2. The MOH was proposed
to decide on forms of
application for granting
conclusions on the quality of
a medicinal product imported
to Ukraine, as well as the list
of the imported medicinal
products.
3. The application for granting
a conclusion on the quality
of a medicinal product
Provided by
imported to Ukraine should
be accompanied by copies
of the documents, certified
by the applicant, confirming
compliance with the
conditions of storage at all
stages of distribution from
a producer to an importer
(device print outs).
4. It provides for expansion
of the list of medicinal
products that should
undergo laboratory analysis.
In particular, in addition to a
series of medicinal products
imported into Ukraine for
the first time, vaccines,
toxoids, tuberculosis allergen,
tetanus toxoid and rabies
7