C A C U A TO R S
On Amendments to Certain Legislative Acts of Ukraine
concerning the prevention of drug falsification
(Information of the Verkhovna Rada of Ukraine (VR), 2012, N 19-20,
(c)
{With changes made according to the Code
N 4651-VI ( 4651-17 ) from 13.04.2012, VR, 2013, N 9-10,
N 11-12, N 13, pp. 88}

Verkhovna Rada of Ukraine Oh, I am. :
I. Amend the following legislative acts of Ukraine:

{Paragraph 1 I lost the validity of the Code
N 4651-VI ( 4651-17 ) From 13.04.2012}

2. In the Code of Ukraine on administrative offences
( 80731-10 , 80732-10 ) (Information Of The Supreme Council Of The Ukrainian SSR,
1984, addition to N 51, pp. 1122):
1) complement the article 44-2 of this content:
" Article 44-2. Falsification of medicines or circulation
Falsified Medicines
Intent to manufacture, purchase, transport, transport and
storage for the purpose of excitation or excitation is known to falsified
hospitals, committed in small size,-
Pull the penalty from twenty to fifty.
The non-tax income of the citizens.
A note. The small size of the medicines is determined
Specially authorized body of the executive branch in the field of
Health ";
2) in the title and paragraph of the first part of the first article 188-10
"Public Quality Control of the Medicines"
replace the words " state control bodies for the quality of the
the terms and conditions of their production ";
(3) Article 244-8 in this edition:
" Article 244-8. State of State Control of Quality
Medicines and the conditions of their production
State of the State Control for the Quality of Medicines and
the conditions of their production are considering cases of administrative
Offences related to illicit production,
fabrication, acquisition, moving, storage with intent
or illegal information of medicines (Article 44-2), with
violation of the established order of capture, processing, storage,
the implementation and application of donor blood and (or) its components
and drugs (Article 45-1), with understate requirements of standards,
rules, regulations and technical conditions during production, storage,
transport, implementation or use of medicines
(Article 167-170) as well as with the failure of the legal requirements of the officials
of the executive branch of the executive branch in the field of quality control and safety
Drugs (article 188-10).
On behalf of the State Control Authorities
the terms and conditions of their production to consider cases of
administrative offenses and overlay administrative
The charge is entitled: State Inspector of State of Ukraine
Hospitals and its deputies, chief public inspectors
from medicines in the Autonomous Republic of Crimea, areas of
cities of Kiev and Sevastopol and their deputies, state inspectors
"Hospital".
3. In the Criminal Code of Ukraine ( 2341-14 ) (Information
The Verkhovna Rada of Ukraine, 2001, N 25-26, pp. 131):
(1) Article 305 of the Board of Editors:
" Article 305. Drug smuggling, psychotropic drugs
substances, their counterparts or precursors or
Falsified Medicines
1. The smuggling of drugs, psychotropic substances, their
analogues or precursors or falsified medicines,
" I mean, they move through the customs border of Ukraine outside of customs
control or with hiding from customs control,-
Punishable by imprisonment from three to eight
years with the confiscation of drugs, psychotropic substances, their
analogues or precursors or falsified medicines that
were subject to smuggling.
2. Same actions, re-committed or in previous language
a group of persons, and if the subject of these actions were particularly
dangerous drugs or psychotropic substances or
drug, psychotropic substances, their counterparts or precursors
or falsified medicines in large sizes,-
Punishable by imprisonment of five to ten
years with the confiscation of drugs, psychotropic substances, their
analogues or precursors or falsified medicines that
were subject to smuggling, and with confiscation of property.
3. Drug contracts, psychotropic substances, their
analogues or precursors or falsified medicines,
committed by an organized group and also if the subject of smuggling
were drug, psychotropic substances, their counterparts, or
precursors or falsified medicines in particularly large areas
size,-
punishable by imprisonment from eight to twelve.
Years with the confiscation of narcotic drugs, psychotropic substances,
their counterparts or precursors or falsified medicines,
What were the subject of contraband and the confiscation of property.
A note. The concept is large and especially large.
drug, psychotropic substances, their counterparts, or
Precursors as well as poisonous or highly toxic substances or poisonous substances
or falsified medicines, or falsified medicines
the means used in this section is determined by
Specially authorized body of the executive branch in the field of
Health ";
2) complement the article 321-1 this content:
" Article 321-1. Falsification of medicines or circulation
Falsified Medicines
1. Intentional fabrication of falsified medicines, and
the same acquisition, transportation, transfer or storage for the purpose of
The excitation is known to falsified medications if
such actions have created a threat to the life or health of the person, or committed
in large sizes,-
are punishable by a fine of thousands to two thousand intaxable.
minimumms of income citizens or limiting the will to three
years, or devoid of will on the same lines, with confiscation
falsified medicines, raw materials and equipment for their
fabrication.
2. The same actions if they are committed again or by
in the previous language of a group of persons, or in particularly large sizes,
or if they caused a lasting health disorder, and so
The same production of falsified medicines,
Punishable by imprisonment for three to five years
with the confiscation of falsified medicines, raw materials and
equipment for their fabrication.
3. Actions provided by parts of the first or second of this article,
if they caused a person's death or other serious consequences,
Punishable by imprisonment of five to ten
years with the confiscation of falsified medicines, raw materials,
equipment for their manufacture and property.
4. The person who voluntarily surrendered falsified to hospitals
the means and indicated the source of their acquisition or contributed to the revelation
crimes related to their circulation are exempt from criminal charges
responsibility for making, acquisition, shipping,
forwarding or storage to the intent, the excitation is known
Falsified medicines, their import into the territory
Ukraine, coming from Ukraine, transit through its territory
(part one of this article if such actions did not create threats to
life or health of people) ".
4. In the Law of Ukraine "On Medicines" ( 123 /96-PL )
(Information of the Verkhovna Rada of Ukraine, 1996, N 22, pp. 86; 2007,
N 3, st. 30, N 34, st. 446):
(1) Part of the first article 2 to complement the paragraph of this content:
" falsified by the drug-the hospital, which
Deliberately promarvated unidentically (non-respectively) information (one of
or a few of them) about the hospital with the appropriate name, which
made up to the State Register of Medicines of Ukraine, and so
the same hospital, deliberately forgery in a different way, and not
matches the information (one or more of them), including
composition, about the hospital with the appropriate name made to
"State Register of Medicines of Ukraine";
2) in part 3 of the third article 4 words " State Committee of Ukraine
from the medical and microbiology industry " to replace the words
"the Central Authority of the Executive Power on Medicines";
3) in Article 9:
Part three after the words "manufacturer's address" to complement the words
"addresses of its location and production facilities";
Part of this:
" To the State Register of Medicines of Ukraine
Information about the hospital: the name of the hospital
(trade name, international non-proprietary name); manufacturer
(name, location of the legal person and its production facilities)
capacities); synonyms, chemical name, full of medicinal
a means; pharmacological action, pharmacotherapeutic group of the hospital
a means; showing, countering, precautions, interaction with
other medications; methods of application, dose of the acting
material in each unit and the number of units in the package; side
action, release form, storage conditions, validity period, conditions
leave; manual for medical application of a hospital
a means; a pharmacotry article or methods of control of the quality of a hospital
Means ";
(4) Part of the third article of the 10 is set out in this edition:
" General requirements for a material and technical framework for
the production of medicines, conducting production control of their
quality as well as technological regulations
The central authority of the executive branch of medicines ";
(5) Article 14 of the Board of Editors:
" Article 14. State of the State Control for the Quality of Hospital
and conditions of production
Control of the quality of medicines and conditions of their
the production is carried out by the central body of the executive branch
Medicines and subjugation
of the executive authorities on medicines according to
Right.
Central Agency for the Executive Power of the
is headed by a supervisor who is in office as the Main State Inspector
Ukraine in Medicare. Head of Central Authority
The executive branch of medicines has two deputies, including
including one of the first to be held by the deputies of the Main
The State Inspector of Ukraine on Medicare.
Governing bodies of the executive branch of the executive branch
The office of medicines by office is the main public inspectors
of the medicines in the respective territories, and their deputies
Under the Deputy Chief Public Inspector of
Hospitals in the respective territories.
Other specialists of the central authority of the executive branch
medicines and specialists of its territorial organs, on
The State of the Republic of the United States of America
are under the position of public inspectors from the hospital
";
6) in part of the second article 17 words " State Inspection of
controlling the quality of medicines "replacing the words" central
the authority of the executive branch of medicines. "
II. Final Position
1. This Act will take effect from 1 November 2011, except
Chapter II, paragraph 2, which will take effect from the day of publication
of this Act.
2. Cabinet of Ministers of Ukraine until 1 November 2011:
bring their legal and legal acts into compliance with this
By law;
Provide guidance to ministries and other central
the executive branch of its regulations in the
A compliance with this Act.

President of Ukraine V. YASUKOVIC
Um ... Kiev, 8 September 2011
N 3718-VI