New requirements have been introduced in Turkey establishing
tobacco manufacturing facilities, as well as related permits for
establishment and operation. The Regulation Amending the Procedures
and Principles of Production and Trade of Tobacco Products
("Amendment Regulation") was published
in Official Gazette number 29572 on 24 December 2015, entering into
effect on the same date.
Significant amendments made to the Regulation on Principles and
Procedures of Manufacturing and Trade of Tobacco Products by the
Amendment Regulation include:
Establishing Tobacco Manufacturing Facilities
The Amendment Regulation introduces
extensive changes for the authorizations and precautions related to
preventing environmental pollution.
Under the Amendment Regulation, to
obtain an establishment permit for manufacturing facilities of
tobacco products for cigarettes and chopped tobacco products for
rolling, the Ministry of Environment and Urbanization
("Ministry") must first give a Positive
Environmental Impact Assessment, or a decision that an
Environmental Impact Assessment is not required.
Manufacturing facilities must be
located in a detached or dedicated building with closed area. In
organized industrial zones or industrial areas, such facilities
must be at least 10,000 m2, or at least 1,000 m2 for facilities
located in other places.
A Manufacturing Establishment permit from the Tobacco and
Alcohol Market Regulatory Authority
("Authority") is required to establish
manufacturing facilities for tobacco products. The Amendment
Regulation introduces a Certificate of Compliance for Establishing
Facility, which is valid for three years. If an applicant fulfills
the requirements, the Authority issues a Certificate of Compliance
for Establishing Facility. The Authority receives the discretion to
grant an extra year after the document's validity period
expires. If a project is not completed within the given time, a
Certificate of Compliance for Establishing Facility will be deemed
The Amendment Regulation introduces
new requirements for Operation Permits. Accordingly, it is now
obligatory to display an easily readable signboard at least three
meters above the ground, including the company name and logo,
production category, as well as the warehouse name. It should be
placed at the main entrance of the facility, as well as the main
entrance for the warehouses holding raw material and finished
Manufacturers must obtain a separate
Operation Permit from the Authority for each category of tobacco
products produced by the same facility. The Amendment Regulation
introduces a requirement that a 500m2 covered area must be added at
the facility for each category of tobacco.
Alteration of Projects
The Amendment Regulation makes significant amendments for
alteration of projects, including introducing two categories for
machines, with separate requirements for each category:
Category one: Includes
vascular slaughter machines directly used in tobacco manufacture,
machines used for production and packaging, as well as filter rod
manufacturing machine. Authority permission is required to make an
addition to these machines, transport them, transfer to another
company, as well as to export or destroy them.
Category two: For machines
not included in Category one, it is sufficient to notify the
Authority about additions, transportation, transfers, exports or
destroying such machines.
Facilities with Existing Operation Permits
Facilities which obtained an Operation Permit before 24 December
2015 are subject to an inspection within 90 days of that date, to
determine compliance with the Amendment Regulation's
The Authority has discretion to grant extensions until 31
December 2016 for facilities to become compliant with requirements
under the Amendment Regulation.
Please see this link for full text of the Amendment
Regulation (only available in Turkish).
Information first published in the MA | Gazette, a fortnightly legal
update newsletter produced by Moroğlu Arseven.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Inquests are something which affect a vast range of NHS and private organisations, as well as individual clinicians, and so we provide a brief overview of recent developments as well as a couple of key potential changes to come.
Le 28 janvier dernier, le Président du Tribunal de grande instance de Nanterre, statuant en référé, a accordé des dommages et intérêts au titre du préjudice d'anxiété à certaines victimes du Mediator dans trois jugements.
The Turkish Competition Board has launched an investigation into the alleged blocking by the Turkish Pharmacists Union of "named patient sales" by pharmaceutical warehouses.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).