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The New Law Amending Certain Laws on Health in Turkey
The Law amending certain laws on health with the purpose to update regulations in accordance with practices concerning pharmaceutical industry, to preclude the violence against healthcare providers, to ensure the healthcare services are given better and more efficient, to regulate donating eggs and reproductive cells for protection of lineage, to prevent common usage of tobacco products, to regulate the rights and other matters of family practitioners and to enlarge the scope of general health insurance regarding test-tube baby practices has recently entered into force as of its publication in the Official Gazette dated December 5, 2018.
The essential amendments regarding the pharmaceutical industry are as below:
Amendments to the Law No. 984
concept of named patient supply system (NPS) had been previously provided by
the Guideline on Provision and Use of Pharmaceuticals from Abroad. However, it is the first time this concept is provided
under a law. The new provision defines the NPS system as same as the Guideline, but mandates to apply
for a license within a certain period of time.
According to the new provision, the pharmaceutical products which are
not licensed or licensed but not released for various reasons can be provided
from abroad with named patient basis in purpose of private usage by the
establishments which are approved by Ministry of Health (“MoH”) through the agency of Social Security Institution (SGK) and
Turkish Pharmacist’s Association (TEB).
Differently from the Guideline, as the product enters in the abroad
list, it is compulsory to apply for license in 3 years and get the license
within 2 years as of the application. The President will be entitled to decide to
continue to the provision of the respective product from abroad, if the
application is not made or the license is not obtained within the said
durations. For the products which has been already provided from abroad, the 3-year
duration of compulsory application, and for the products which has been applied
to obtain license, the 2-year duration of obligation to obtain license start as
of December 5, 2018.
The administrative fines to be applied to the owners or responsible managers of
pharmacy trading houses in case of breach of the law have been increased to the
range of 2.000 and 20.000 Turkish Liras. If the breach repeats in a year, the
administrative fine will be doubled. In addition the new provision differently
provides that if the selling of the respective substances creates any danger,
the activities of the respective business organization shall be suspended
temporarily until such danger is eliminated.
The respective provision further authorizes the Turkish Pharmaceuticals
and Medical Devices Agency as the applier of the sanctions, in addition to the
local administrations. With this amendment the legislator aims that the
penalties could be applied in time without any delay.
the amendment, at least one of the shareholders was required to be a pharmacist
and authorized as a responsible manager in pharmacy commerce houses i.e.
drugstores, pharmacy warehouses. Such requirement has been revoked with the
amendment and accordingly pharmacy commerce houses could be established without
any requirement of profession.
Amendments to the Law No: 1262
amendment with the aim of adjusting the regulations in accordance with practices
provides that the pharmaceutical manufacturing laboratories or factories must produce
products pursuant to “Good Manufacturing Practices” standards, which has been already
being required by the Turkish Pharmaceuticals and Medical Devices Agency.
and analysis which are required to get authorization to produce pharmaceuticals
can be made in authorized private laboratories in addition to laboratories of the
MoH. The respective amendment is a positive development for pharmaceutical
producers since the results of the tests and analyses were waited for a period
of time. With this amendment, it is expected that the waiting-period will be
shorter since the MoH will authorize private laboratories and distribute
Amendments to the Law No: 5996
Turkish Pharmaceuticals and Medical Devices Agency will be the only authority
which is able to allow the health claim usage in advertisement, promotion and
label of foods. Before this provision, it was not clear whether the MoH or the
Ministry of Agriculture and Forestry is the competent authority regarding the
health claims used in foods. The amendment seems to avoid this confusion.
Other Essential Amendments to Various Laws
The Amendment to the Law No. 2238 provides new provisions on organ
and tissue transplantation and assisted reproduction treatments and also
provides heavier judicial and administrative punishments for who is responsible
for transplanting, selling, buying, or donating of organ, reproductive sells,
eggs and embryos.
The Amendment to the Law No. 4207 foresees that an information regarding
tobacco’s harms and damages must be seen on (at least 85% of) the surface of
the packages and the brand must be standardized with its color, type size and type
font. Also the logo, icon or other symbols of the brand must not be placed on
the packages. Tobacco companies must comply with this amendment within 7 months
by changing product packages. However, the Ministry of Agriculture and Forestry
is entitled to extend such transition period for an additional 6 months. A
regulation which will guide regarding the details of these standardized
packages is expected to be published by the Ministry of Agriculture and
Forestry within the transition period.
The Amendment to the Law No. 6023 removes the provision which bans workplace
doctors or the doctors in a private health institution from working for more
than one place.