Edition 61: 22 February 2018
Editorial Team:
Orçun Çetinkaya, LL.M., Ezgi Baklacı, LL.M., and Pelin Oğuzer, LL.M.
Turkey Updates Rules for Electricity Licenses, Along with Data and Share Transfer Provisions

Turkey has updated electricity legislation relating to calculation of guarantee amounts, reporting obligations, prohibition of share transfers, as well as notification obligations during share transfers. The requirement to hold data processing centres within Turkey has now also been removed.

The Regulation on Amendment of the Electricity Market Licencing Regulation (“Amendment Regulation”) was published in Official Gazette number 30271 on 15 December 2017.

Notable changes include:

– The pre-license guarantee amount will no longer be deducted from the guarantee required for electricity production license applications.

– License holders must now take all necessary technical and administrative measures to:

– Prevent illegal access and processing of data.

– Ensure data confidentiality, integrity and accessibility at in-house data processing centres and/or centres they receive services from.

– Data processing or storage centres are no longer required to be located in Turkey.

– The prohibition on pre-license holders changing their shareholding structure during the application process, as well as share transfers and equivalent transactions during this time, will no longer applied for:

– Share transfers between real persons who are:

– The pre-license holder’s direct or indirect shareholders, and

– Spouses or first-degree blood relatives.

– Direct or indirect change of shareholding structures in pre-licence holders which the Saving Deposit Insurance Fund has taken control of.

– The licensee must request the license be amended if:

– 10% or more privately held shares are transferred

– 5% or more publicly held shares are transferred.

– The Energy Market Regulatory Authority (“Authority”) must now be notified within one year about changes to the shareholding structure, changes to control, or equivalent transactions for foreign shareholders. A further request to amend the license should be made within six months of notifying the Authority, if necessary.

– Distribution companies are no longer required to report each year by the end of November. Rather, such companies must now report when the Authority requests.

 Please see this link for full text of the Amendment Regulation (only available in Turkish).

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Turkey Overhauls Natural Gas Certification Regime

Turkey’s Energy Market Regulatory Authority (“Authority”) has overhauled rules for natural gas certificates and related processes. Changes apply to rules for authorisation certificates, as well as processes for amending, renewing and cancelling certificates.

The Regulation Amending the Natural Gas Market Certification Regulation (“Amendment Regulation”) was published in Official Gazette number 24887 on 22 September 2002. It makes changes to the Natural Gas Market Certification Regulation (“Regulation”).

Notable changes include:

– From July 2018, certified identity cards will be introduced for employees working at companies which hold authorization certificates.

– Authorization certificate applications must now include an undertaking letter stating the applicant’s activities comply with the Regulation.

– If the Authority identifies any deficiency or mistake in an application, it will now contact the applicant and invite a representative to come discuss this. Applicants must submit any missing documents or information within 60 days, otherwise the application will be deemed as invalid.

– The Agency will now refund the application fee if it rejects an application for a production or service certificate.

– Certificate holders which do not obtain a visa, must now cease business activities and will not be able to conclude new contracts with customers.

– Sanctions will apply to certificate holders operating without a visa.

– Production and service certificates will now be valid for two years from the effective date, or from the visa’s commencement date.

– Domestic installation and service lines certificates will now be valid for one year from the effective date, or from the visa’s commencement date.

– Applications to renew production and service certificates must now made between 45 and 180 days before expiry. The Department of Natural Gas Market must respond to applications within 45 days.

– Applications to renew domestic installation and service lines certificates must now be made between 10 and 20 days before expiry. The relevant company must complete its evaluation within 30 days.

– For visa applications, contradictions with the Regulation must be rectified within 30 days of the notification date, or else the application will be deemed invalid and the application fee refunded.

Please see this link for the full text of the Amendment Regulation (only available in Turkish).

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Turkey Increases Administrative Fines for 2018 for Energy Sector

Turkey’s Energy Market Regulatory Authority (“Authority”) has increased administrative fines related to electricity, natural gas, oil and LPG by 14.47% from 1 January 2018, based on the Treasury’s annual revaluation rate, determined for 2017.

The Treasury announced the 2017 revaluation rate under the General Communiqué on Tax Procedural Law number 484, published in Official Gazette number 30237 on 11 November 2017.

Accordingly, the Authority announced the energy sector increases via separate communiqués published in Official Gazette number 30227 on 21 December 2017. The respective communiqués for each market can be found at the following links (only available in Turkish):

– Liquified Petroleum Gas (LPG) Law number 5307 at this link.

– Petroleum Market Law number 5015 at this link.

– Natural Gas Law number 4646 at this link.

– Electricity Market Law number 6446 at this link.

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Turkish Medicine and Medical Device Agency: 28% of Cosmetic Products Inspected in Q4 2017 were Either Technically Deficient or Unsafe

The Turkish Medicine and Medical Device Agency (“Agency”) has announced inspection figures for cosmetic products during the fourth quarter of 2017. The Agency’s inspections found 111 of 398 cosmetic products (28%) inspected during this period to be either technically deficient (105 products) or unsafe (6 products). The majority of these were skin care products. As a result, the Agency issued a total of 444,727 Turkish Liras worth of administrative fines during Q4 of 2017.

The Agency’s announcement includes figures along with details about the products such as:

– Product owners.

– Trademarks.

–  Serial numbers.

– Barcode numbers.

– Origins.

– Reasons for deficiency.

The source countries for deficient and unsafe cosmetic products included France and Turkey.

Please see this link for full text of the Agency’s announcement (only available in Turkish).

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Turkish Medicine and Medical Device Agency Announces New Rules for Using the Phrase “Apyrogenic” on Pharmaceuticals

The Turkish Medicines and Medical Devices Agency (“Agency”) has announced new conditions for using the phrase “apyrogenic” on pharmaceuticals, along with transitional procedures (“Announcement”). The transitional procedures must be completed by 30 June 2018, or else pharmaceutical companies must remove the phrase “apyrogenic” from product packaging and patient leaflets manufactured after this date.

The Agency published the Guideline Regarding Pharmaceuticals’ Packaging Information and Patient Leaflets, based on the Regulation for Pharmaceuticals’ Packaging Information, Patient Leaflet and Tracking of These published in Official Gazette number 30048 on 25 April 2017.

According to the Guideline, apyrogenic products must have the phrase “apyrogenic” on the inner and outer packaging, as well as patient leaflets. However, as per the Agency’s recent Announcement, the “rabbit pyrogen test” becomes to only acceptable registered testing method within finalized product specifications for pharmaceutical preparations to qualify to use the phrase “apyrogenic”.

Pharmaceutical companies which wish to use the phrase “apyrogen” on pharmaceutical preparations, but do not use the “rabbit pyrogen test” as the registered testing method in finalized product specifications, must apply to either of the following bodies (depending on the pharmaceutical’s type), submitting up-to-date information and data:

– Licensed Medicine Technological Evaluation Unit for Type IA or Type IB

– Biologic and Biotechnological Products Unit for Type II variations.

The application requirement above includes companies which already have Agency approval to use the phrase “apyrogen”.

For pharmaceutical companies to continue to use the phrase “apyrogen” on products which adopt the “rabbit pyrogen test” as the registered testing method in the finalized product specifications, these companies must apply to the Licensed Medicine Technological Evaluation Unit for authorized pharmaceuticals or the Biologic and Biotechnological Products Unit depending on the pharmaceutical, with up-to-date information and data.

Please see this link for full text of the Guideline (only available in Turkish).

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Turkey Updates Rules for Road Transport

Turkey had made a range of changes to streamline transport-related applications and improve road safety. These changes introduce online applications, as well as reduce the fees and document requirements for obtaining authorization certificates.

The Road Transport Regulation (“Regulation”) was published in Official Gazette number 30295 on 5 January 2018, entering into effect on the same date.

The Regulation removes the prior requirement to make physical applications, while simultaneously introducing an online application system for this purpose. Applications will now be made electronically via the e-Government system.

The e-Government system will now be used to:

– Conclude transportation and agency agreements.

– Establish vehicle cards.

– Organize timetables, rates and routes.

– Compile branch and agency lists.

The Regulation makes many amendments to authorization certificates, which generally reduce the required documents, as well as the fees for some certificates and renewals. Authorization certificates will now be requested via e-Government.

Legal persons are now required to have an e-mail address in order to obtain an authorization certificate and notifications will be made electronically.

Driving trainings will now be obligatory for drivers. Institutions under the Ministry of National Education will offer trainings of at least seven hours of practical and theoretical lectures per year.

The Transportation Electronic Monitoring and Control System has also been established, to monitor passengers, goods and shipments. Authority-holders must record the following information in this system:

– Trips.

– License plates.

– Passenger information.

– Delivery descriptions

– Status of trips and deliveries.

Please see this link for the full text of the Regulation (only available in Turkish).

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