Upharmacia October 2017
of subjects responsible for the
introduction of medical products in
circulation. This register indicates
the location of the manufacturers
or their authorized representatives
and a list and description of the
relevant medical products.
However, despite the validity of
technical regulations, the draft does
not contain conditions for taking
into account their peculiarities
when issuing the corresponding
licenses for medical products, but
only references to the Law “On
Medicines”, which, obviously, should
be taken only in the context of
medicinal products.
We draw your attention to the fact
that today medical products are
sold by a wide range of subjects
on the market, including selling
through supermarkets, shops and
refuelling stations. Accordingly,
given the complexity of the licensing
process and the requirement,
for example, to entities to
provide special conditions for
the transportation or storage of
licensed products in special licensed
warehouses, it is possible to predict
a narrowing of the range of entities
that will be engaged in the relevant
economic activity.
C hanges in the P rocedure
for S electing D rugs to the
N ational L ist A pproved
The MOH adopted the Order “On
Amendments to Orders of the
Ministry of Health of Ukraine No. 84
as of Feb 11, 2016 and No. 1050 as
of Oct 7, 2016” No. 885 as of Aug 1,
2017, which amends the Regulation
on the National List of Essential
Medicines and the Regulation
on the Expert Committee on the
Selection and Use of Essential
Medicines.
The purpose of this regulatory
act is to bring the algorithm for
introducing changes into the
National List in line with the needs
of the healthcare system and the
calendar plan, which delays the
application of the National List.
Now the Expert Committee on
the Selection and Use of Essential
Medicines is developing a list of
drugs to include in the National List
by the end of 2017. In accordance
with Order of the Ministry of Health
of Ukraine No. 558, such selection
is carried out taking into account
the 20th version of the WHO Model
List, the nomenclature of medicines
procured for budgetary funds and
industry standards. Procurements
in 2018 will take place based on
such supplemented National List.
In the future, the National List will
be supplemented regularly once
a year. By Jul 1st of each year, the
advisory body will form the next
edition of the National List, submit
it to the Ministry of Health of
Ukraine, which in turn will submit
the draft resolution of the Cabinet
of Ministers on introducing the
changes to the Government.
Read more on Legal Alliance website
HEALTHCARE NEWS
N ational H ealthcare S ervice to
be C reated in early 2018
The government expects to create
the National Healthcare Service of
Ukraine (NHSU) – an independent
customer of services responsible
for financing the health system
– at the beginning of 2018, the
Deputy Head of the MOH Pavlo
Kovtonyuk stated. According to him
the Ministry has already developed
a lot of legislative acts for the
implementation of the Law on state
financial guarantees approved by
the Parliament on Oct 19.
The NHSU should become the key
8
authority within the reformation of
the Ukrainian healthcare system.
Until it is created, the functions of
funding the health care services will
be carried by the MOH. Co-author
of the reform MP Serhiy Berezenko
stated that the functioning of the
NHSU would be controlled by audit
service, Chamber of Accounts,
National Agency on Corruption
Prevention and National Anti-Cor-
ruption Bureau of Ukraine.
P harma C ompanies C onsidering
I ntroduction of QR- coding
Ukrainian producers of phar-
maceuticals are considering the
possibilities of introduction of
QR-coding of drugs packs, the
Director of Professional Pharmacy
Association of Ukraine Volodymyr
Rudenko stated.
“Such labeling of imported and
local drugs in Ukraine is only at
planning stage,” Mr. Rudenko
stated. “Currently, the labeling
with QR-codes is almost not
implemented”.
A number of experts thank that the
implementation of QR-coding of
medicinal products could take 2-3
years due to the shortage of the
appropriate equipment.
www.upharma-c.com