C A C U A TO R S
On Amendments to Certain Laws of Ukraine
in the area of health care for strengthening control
for the circulation of medicines, food products
for special dietary intake,
functional food products and dietary additives
(Information of the Verkhovna Rada of Ukraine (VR), 2012, N 30, pp. 348)
{With changes under the Act
N 222-VIII ( 222-19 ) 02.03.2015, AVR, 2015, N 23, pp. 158}

Verkhovna Rada of Ukraine Oh, I am. :
I. Amend the laws of Ukraine to be amended:
1. Part of Article 19 of the Constitution of Ukraine
Health care ( 2801-12 ) (Information of the Verkhovna Rada of Ukraine,
1993, N 4, pp. 19) after the word "State"
" provides compliance with the requirements of the law to limit advertising
Hospitals and the "
2. In the Law of Ukraine "On Medicines" ( 123 /96-PL )
(Information of the Verkhovna Rada of Ukraine, 1996, N 22, pp. 86; 1997,
N 15, st. 115; 2006, N 22, pp. 184):
(1) Part of the first Article 3 after the word "by" supplement
" The conduct of the State Register of Medicines of Ukraine with
Providing public access to the person ";
(2) In Article 10:
part of the first complement of the sentence of such content: " In the appendix to
licenses are noted for the list of drug forms permitted by the
to the production of the licensee, as well as the special conditions of failure
Activities ";
part of the second complement of the sentence of such content:
" compliance with the material and technical base, the qualifications of personnel,
as well as the conditions for controlling the quality of medicines that
to be produced, set requirements and stated in the
a statement of documents to obtain a license of characterization
is subject to mandatory verification of the issuance of licenses within
strings provided for the issuance of licenses, by the place of failure
of the licensing authority in the order defined by the central
The executive body in the field of health ";
(3) Part of the first article 17 shall complement the sentence of such content:
" Order of the use of medicines in the territory of Ukraine
is set by the Cabinet of Ministers of Ukraine ";
(4) In Article 19:
in part the first word "physical individuals-subjects"
Enterprise activities "replace the words" by individuals-
Entrepreneurs ";
after part of the first complement to a new part of this content:
" The basis for issuing licenses is the presence of
Material and technical framework, qualified personnel,
The consistency of which is set to the requirements set and stated in the
a statement of documents to obtain a license of characterization
will be subject to mandatory verification before issuing a license within
strings provided for the issuance of licenses, by the place of failure
the authority of the licensing authority or its territorial
units in the order established by the central authority
of the Executive Committee in the field of health care ".
In this regard, part of the second is considered part of the third;
(5) Article 21 after part of the second supplement
such content:
" Implementation (admission) to citizens of medicines for
A doctor ' s prescription is carried out in order established by the central
the authority of the executive branch in the field of health care. "
For this part, the third part is considered part of the fourth;
(6) In Article 26:
after part of the second complement of the new part of this content:
"Information on hospitals (including drugs)"
not registered or are in the development stage or
Adoption of the agenda,
medicinal properties, possible side action and published in
publications intended for medical and pharmaceutical workers,
as well as in materials distributed in specialized media.
workshops, conferences, symposia on medical topics. "
In this regard, parts of the third are sixth to be considered respectively
Quarter-seventh;
Part of the fourth edition:
" The advertising of medicines is allowed.
without a doctor ' s recipe and not made to the list of banned
Drug promotion. List of medicines,
prohibited from advertising, approved by the central authority
of the Executive Committee in the field of health care. Advertising requirements
of such medicines are established by the Law of Ukraine " On
advertising " ( 270 /96-PL ). Criteria to apply when defined
Drugs whose advertisements are prohibited
by the Central Authority of the Executive Power in the Field of Health
See the law. Decision on the abandonment of the hospital
A vehicle for which drugs are prohibited,
accepted during public registration (pereregistration)
Doctor of the United States of America
State Registry of Medicines of Ukraine. Advertising for hospitals
tools, applications and disallowed only for
a doctor ' s prescription, as well as those made to the list of banned
to advertise the medicines ";
7) in the text of the Law (art. 123 /96-PL ) " Ministry of Conservation
the health of Ukraine "in all differences, replace the words" central
the executive body in the field of health " in appropriate
Mark.

{Paragraph 3 of section I lost the validity of the Act
N 222-VIII ( 222-19 ) 02.03.2015}

4. In Article 21 of the Law of Ukraine "On Advertising" ( 270 /96-PL )
(Information of the Verkhovna Rada of Ukraine, 2004, N 8, pp. 62 of
The following changes):
1) in part one:
in a paragraph of the second word "medical technique" to replace the words
"Medical products and";
paragraph of the third set in this edition:
" only such medicines that are released without prescription.
a doctor and which is not made by the central body of the executive
Health care services to the list of medicines,
Banned from advertising ";
2) in the second word "which are used and disseminated"
only for the stop (recipe) doctor "replace the words"
" applications and disclosures are allowed only by prescription
a doctor, as well as on the list of banned advertising
Drugs ";
(3) Part of the fourth edition:
" 4. Advertising of medicines, medical products, methods
Prevention, diagnosis, treatment and rehabilitation
Contain:
Objective information on the drug, medical care,
prevention, diagnosis, treatment, rehabilitation and
make it clear that the message is
advertising, and the advertising product is a drug, medical and
A product, by prevention, diagnosis, treatment,
Rehabilitation;
Request the need for consultation with the doctor before
Application of a drug or medical device;
recommendation on compulsory familiarity with the
Hospital;
a warning text of such content: " Self-treatment may be
harmful to your health ", which takes at least 15 percent
the area (duration) of the entire advertising ";
4) in parts of the fifth, seventh and thirteenth words of " medical
The techniques "replace the words" of medical products and ";
5) in part six:
in the paragraph of the first word "medical technique" substitute
"Medical products and";
The second and third of the paragraphs in this edition are:
" information that can help the impression that the condition
application of drug or medical advice to
A specialist is not necessary;
information about the treatment effect from application
A drug or medical device is guaranteed ";
in the paragraphs of the fifth, seventh, eighth and ninth words
"medical equipment" in all differences to replace the words " medical
In the relevant case;
in the paragraph of the thirteenth word of the "medicinal" substitute
The words "the advertising";
(6) Part of the ninth meeting in such an editorial:
" 9. In advertising of goods and methods not belonging to
medicines, medical products, prevention techniques,
diagnosis, treatment and rehabilitation, as well as in food advertising
products for special dietary consumption, functional
Food and dietary supplements are prohibited to refer to
to the fact that they have medicinal properties. "
II. Final Position
1. This Act will take effect from the day, next in the day
Publication other than sub-paragraph 6 of paragraph 2 and paragraph 4 of section I
this Act, which takes effect six months from the day
The law is in force.
2. Set that the advertising of medicines registered
In Ukraine before the entry into force paragraph 6, paragraph (2) and paragraph 4
section I of this Act may only be carried out after
Relevant changes to the State Register of Medicines of Ukraine.
3. Cabinet of Ministers of Ukraine in a three-month period
The Act:
bring their legal and legal acts into compliance with this
By law and to ensure the development and adoption of new
Regulatory and legal acts that need to be derived from this
Law;
provide a view and cancellation of ministries and other
The central authorities of the executive branch of Ukraine
the legal and legal acts contrary to this Act, and
Adoption of new regulations, the need for
It follows from this Act.

President of Ukraine V. YASUKOVIC
Um ... Kiev, 20 December 2011
N 4196-VI