Edition 07: 1 October 2015
Editorial Team:
Dr. E. Seyfi Moroğlu, LL.M., Işık Özdoğan, LL.M. and Bora İkiler, LL.M.
Regulation Amending the Electricity Market Consumer Services Regulation Comes Into Effect

The Regulation Amending the Electricity Market Consumer Services Regulation was published in Official Gazette number 29477 on 16 September 2015 (“Regulation”). It amends application and termination procedures for electricity retail sales agreements, as well as various contract rights, obligations and procedures, among other changes.

Significant changes introduced by the Regulation include:

– The “Market Management System” is made available to market and system operators, market participants and legal entities which read electrometers. The system enables a compensation mechanism and gives access to reconciliation information.

– Commissioned supply companies cannot request a written notification from new consumers who intend to change their current suppliers, regardless of whether they have fulfilled their obligations towards their current suppliers.

– Electricity Distribution companies can no longer cut off a consumer’s electricity on the basis of a retail sales agreement being terminated during change of supplier.

– The Request for Termination of Retail Sales Agreement Form is added as an annex to the Electricity Market Consumer Services Regulation. The form must be used to terminate retail sales agreements, otherwise sanctions under Article 16 of the Electricity Market Law may apply.

– Debts arising from bilateral agreements are no longer a valid reason for cutting off electricity. However, electricity can still be cut off based on debts which arise from retail sale agreements, even if the supplier has changed.

– Previously, consumers were able to request a free, detailed 12 month detailed electricity consumption report from their commissioned supplier company once per year. Such requests should now be made to the electricity distribution company and can be made twice per year. The reports will cover the past 24 months’ electricity consumption in kWh.

– The right of eligible consumers to choose their suppliers can no longer be refused on the basis of improper electrometer usage. Following exercise of this right, the electricity distribution company must change any improper electrometers within the month.

– Records regarding eligible consumers must no longer be kept or published.

– Eligible consumers can change suppliers, even if they have not performed their obligations to their former supplier.

– Before signing an agreement with eligible consumers, suppliers must provide information about consumer rights, commercial options provided under bilateral agreements and possible risks. The consumer should either sign a document acknowledging they have been informed, or the supplier should send the information to the consumer’s registered electronic mail address. Upon request, such documentation will be submitted to the Energy Market Regulatory Authority.

The Regulation enters into force on 16 September 2015. However, Articles 5 and 6, relating to arrears, as well as electricity disconnection and reconnection, enter into force on 1 March 2016.

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

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Amendments Made to Regulation on Clinical Research of Pharmaceutical and Biological Products

The Regulation Amending the Regulation on Clinical Research of Pharmaceutical and Biological Products was published in Official Gazette number 29474 on 13 September 2015 (“Regulation”). Among other changes, the new Regulation removes permit requirements for clinical research centers, as well as changes requirements for ethics committee and education processes.

The Regulation makes changes to the Regulation on Clinical Research of Pharmaceutical and Biological Products (Official Gazette number 28617, 13 April 2013). Significant provisions include:

– Removing the obligation on clinical research centers to have a permit to carry out clinical research from the Turkish Drug and Medical Device Institution.

– For applications to conduct multicenter clinical research, ethics committee approval is required. Approval must be obtained from the committee located in the coordinating center’s region (or closest committee to the coordinating center, if none exists within the particular region). If the research is conducted by a single center, approval must be obtained from the ethics committee located in the research center’s region (or closest regional committee, if none exists within the particular region).

– Extending the deadline to 1 April 2016 for health professionals and ethics committee members to complete primary education about good clinical practice and clinical research. The ethics committees are established by the Regulation on Clinical Research of Pharmaceutical and Biological Products and approved by the Turkish Drug and Medical Device Institution.

The Regulation came into effect on 13 September 2015, when it was announced in the Official Gazette. It is enforced by the President of the Turkish Drug and Medical Device Institution.

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

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New Communiqué Issued For Manufacturing Sites of Dietary Foods For Special Medical Purposes

The Turkish Pharmaceuticals and Medical Devices Agency (“Agency”) published the Communiqué on Manufacturing Sites of Dietary Foods for Special Medical Purposes in Official Gazette number 29474 on 13 September 2015 (“Communiqué”). The Communiqué outlines principles and procedures for sites which manufacture dietary foods for special medical purposes, including processes for licensing and Agency supervision.

Significant provisions in the Communiqué include:

– Dietary foods for special medical purposes (including those intended for export) can only be manufactured at sites which hold a manufacturing site license from the Agency. Annex I of the Communiqué lists the information and documents required during license applications. The Agency will verify the application information’s accuracy and grant licenses to qualifying applicants within 90 days. Agency supervisors will later carry out site inspections to determine whether the applicant’s manufacturing site meets the necessary licensing conditions (Article 5).

– License holders for manufacturing sites must (Article 6):

– Employ appropriate personnel for production, quality control, storage and distribution operations.

– Dispose of unusable products in accordance with legislation.

– Inform the Agency beforehand if the information and documents change from those which were presented during the initial license application.

– Immediately appoint a new responsible manager and inform the Agency if the current responsible manager resigns or cannot carry out his/her duties.

– Allow Agency supervisors to enter the necessary parts of the premises to conduct examinations. Supervisors must present their certificates of authorization during examinations.

– Provide all necessary opportunities for the responsible manager to carry out his/her duties.

– The manufacturing site holder must permanently appoint a responsible manager who meets the criteria specified under Article 7.

– The Agency must supervise licensed manufacturing sites within a set supervision framework, as well as in any other situation it considers necessary (Article 8).

– Manufacturing sites must operate in accordance with the “Good Manufacturing Practice Principles”, outlined in the Communiqué. These address personnel, equipment, premises, manufacturing, quality control, documentation and toll manufacturing (Article 9 and cont’d).

The Communiqué enters into effect on 13 September 2015 and is overseen by the Head of the Agency. For applications made before the Communiqué’s effective date, the relevant legislation in force at the application date will be applied.

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

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Professional Competence Authority Issues Four Communiqués on National Occupational Standards

The Professional Competence Authority has published four communiqués regulating national occupational standards in Official Gazette number 29472 on 11 September 2015 (duplicated).

Communiqué 2015/14 on Amending the Communiqué on National Occupational Standards amends standards for five professions, previously regulated by a communiqué published in Official Gazette number 29472 on 11 March 2010. Accordingly, it amends standards for:

– Serviceman (Level 2).

– Serviceman (Level 3).

– Serviceman (Level 4).

– Barman (Level 4).

– Service Supervisor (Level 5).

Communiqué 2015/15 on Amending the Communiqué on National Occupational Standards amends standards for people working as a Central Control Operator (Furnace) (Level 5), previously regulated by a communiqué published in Official Gazette number 27446 on 28 December 2009.

Communiqué 2015/16 on Amending the Communiqué on National Occupational Standards amends standards for people working as a Travel Sales Officer (Level 4), previously regulated by a communiqué published in Official Gazette number 28020 on 9 August 2011 (duplicated).

Communiqué 2015/17 on Amending the Communiqué on National Occupational Standards amends standards for two professions, previously regulated by a communiqué published in Official Gazette number 27579 on 12 May 2010. Accordingly, it amends standards for:

– Port Crane Operator (RTG and SSG) (Level 3).

– Port Field Fork-Lift Truck Operator (CRS and ECS) (Level 3).

In general, National Occupational Standards are made up of three sections, contemplating the profile and definition of the profession as well as the method for assessment, evaluation and certification.

The Communiqués specify the working environment, equipment, and other occupational requirements such as necessary health checks and trainings (if any). The Communiqués also outline duties and obligations for members of these professions, as well as success criteria and other personal abilities, such as knowledge, skills and behavior.

You may access Communiqué 2015/14, Communiqué 2015/15, Communiqué 2015/16, Communiqué 2015/17 and their annexes through these links (only available in Turkish).

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2015-2018 SME Strategy and Action Plan Issued by Small and Medium Enterprise Development Organization

A Strategy and Action Plan for Small and Medium-sized Enterprises (“SME”) has been issued for the 2015-2018 period (“Action Plan”). It was prepared by the Small and Medium Enterprises Development Organization and announced in Official Gazette number 29466 on 5 September 2015. The Action Plan sets goals for the period to increase the contribution of SMEs to national economic growth and international competitiveness.

The first SME Strategy and Action Plan was issued in 2003 to meet commitments arising from the EU membership ascension process. Industry strategy and action plans ensure national development towards clearly identified goals, in a coordinated and consistent manner.

The Action Plan envisages five strategic objectives and 15 specific actions, taking into account the key problems currently facing SMEs in the industrial, services and commercial sectors. The strategic objectives are to:

  1. Enhance SMEs’ competitive capacity and support economic growth.
  2. Enhance SMEs’ import capacity to be more in line with market levels.
  3. Consider SMEs during improvement of the business and investment environment.
  4. Improve SMEs’ R&D and innovative capacity.
  5. Facilitate SMEs’ access to finance.

Examples of specific actions determined to support the strategic objectives include:

– Transforming unproductive electric motors used in industry.

– Encouraging the aggregation of SMEs to increase capacity for regional competitiveness.

– Preparing guides to support energy efficient technologies and good practice samples.

– Increasing the number of women employees in SMEs.

– Conducting a needs analysis study to protect the intellectual property rights of SME employees.

– Spreading innovation culture among college students.

– Supporting manufacturing industry SMEs through legislative arrangements.

Targets for the 2015-2018 period stated in the Action Plan include:

– Increasing SME exports to US $150 billion.

– Increasing the number of the exporter SMEs to 60,000.

– Maintaining SMEs’ commercial R&D expenses at 33%.

– Employing 3 million new people within SMEs.

You can access the full Action Plan through this link (only available in Turkish).

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Supreme Court Rules on Evidence Determination Procedure

The 4th Civil Chamber of the Supreme Court recently considered a case where the plaintiff claimed an unjust evidence determination had violated its personal rights and damaged his commercial standing. The court held the procedure was justified since it was conducted on the basis of a court decision, no objection had been raised during the determination, and unlawful use of the software by other companies justified the defendant’s request regarding the plaintiff’s specific workplace.

At the Court of First Instance, the plaintiff sought immaterial damages. It claimed an evidence determination procedure, conducted by an expert witness, had found no unlicensed software on his computers. The procedure was conducted without the defendant submitting any documents or evidence to support its claims about the plaintiff’s specific use of counterfeit software. The plaintiff argued that this constituted an abuse of the right to legal remedies and the procedure violated his personal rights, as well as damaged his commercial standing.

The defendant argued before the Court of First Instance that use of counterfeit software by other companies should be taken as an indication of the plaintiff’s unlicensed use. The defendant also argued that since no objections were raised during evidence recording, the process has been legally and duly conducted.

The Court of First Instance partially accepted the plaintiff’s claims, holding that the evidence recording was conducted based on an illegal complaint and this had damaged the plaintiff’s commercial standing. The court based its reasoning on the expert witness report which indicated that no counterfeit software was found during the recording. The defendant appealed the judgement to the Supreme Court.

The Supreme Court overturned the Court of First Instance’s judgment, holding that the defendant’s complaint (which triggered the evidence determination) was legitimate. The court held that the evidence determination procedure had been justified because it was conducted on the basis of a court decision, no objection had been raised during the determination, and unlawful use of the software by other companies justified the defendant’s request regarding the plaintiff’s workplace.

Case reference: Yarg. 4. HD. 28.01.2015, 2014/4987 E., 2015/1053 K.)

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