Upharmacia August 2017
markets of Europe and the US,
we will organize inspection of the
FDA and the European Directorate
for the Quality of Medicines &
HealthCare (EDQM)”.
At the same time Farmak is testing
the possibility of producing own
products at pharmaceutical plants
in Ukraine and Europe. This may
apply to solid forms of drugs
(granules and tablets).
According to Mr. Dubnicka, in 2017
Farmak plans to invest UAH 230 mio
in development of its projects.
Augustin Dubnicka replaced Filia
Zhebrivska at the position of
Farmak’s CEO in Jul. The company
plans to increase its presence on
European market to reach USD 1
bln sales in 2020. In 2016, Farmak
increased its income by 67% y-o-y to
UAH 677 mio.
REGULATORY UPDATES
A C hange in the P rocurement
of M edicines H as B een
A pproved
The Cabinet of Ministers of Ukraine
has again reinstated the deadlines
for mandatory observance by
healthcare institutions and facilities,
fully or partially financed from
the state and local budgets, of the
requirements of Resolution “Some
Issues of State Regulation of Prices
for Medicinal Products and Medical
Devices” No. 333 as of March 25 th ,
2009.
Thus, on August 23 rd , 2017, the
Cabinet of Ministers adopted
a decision according to which
institutions and health care
institutions, fully or partially
financed from state and local
budgets, may procure medicinal
products legitimately registered in
Ukraine and included in the State
Register of Medicinal Products
of Ukraine. Therefore, these
healthcare institutions and facilities
are not required to follow the
National List of Essential Medicines
while procuring medicines in 2017.
T he L ist of R are D iseases H as
B een S upplemented
The Ministry of Health has approved
changes to the List of Rare (Orphan)
Diseases which Shorten Life of
www.upharma-c.com
Patients or Lead to Disability and
for Which There Are Recognized
Methods of Treatment (hereinafter
- the List). The corresponding Order
of the Ministry of Health of Ukraine
No. 731 as of June 29, 2017 has
been registered with the Ministry of
Justice.
Rare endocrine diseases, digestive
disorders and metabolic disorders,
as defined in Section I, have been
supplemented with following 7
new positions: impaired ornithine
metabolism, argininemia, ornithine
carbamoyltransferase deficiency;
impaired glycine metabolism; other
disorders of lipid accumulation,
Wolman's disease; hereditary
erythropoietic porphyria; late
cutaneous horphyria; other
porphyrias; lipomatosis which was
not classified elsewhere.
Section IV list “Rare Diseases of
the Nervous System” has been
supplemented with 10 positions,
which include the following:
Provided by
— — other forms of secondary
parkinsonism;
— — dystonia;
— — craniocervical dystonia spreading
to the larynx and upper limbs;
— — blepharospasm;
— — other dystonia;
— — unspecified dystonia;
— — specific epileptic syndromes;
— — hereditary motor and sensory
neuropathy.
Also, the List has been amended
with Section XI “Rare Diseases
of Sclera, Cornea, Iris and Ciliary
Body”, containing 2 points:
interstitial (stromal) and deep
keratitis (Kogan syndrome), and
iridocyclitis.
— — encephalitis, myelitis and en-
cephalomyelitis; encephalitis,
myelitis and encephalomyelitis
together with diseases classified
in other sections; progressive en-
cephalomyelitis with rigidity and
myoclonus;
— — secondary parkinsonism caused
by other external factors;
7