The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently published the Guideline on Cosmetic Product Information File, Responsible Technical Personnel, Product Safety Assessors and Training, and the Guideline on Conditions for Exports Except to Pharmacies. The TİTCK also amended: (i) the Decree on the Pricing of Pharmaceuticals; (ii) the Regulation on Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices; (iii) the Regulation on Variations in Pharmaceuticals with Marketing Authorization; (iv) the Regulation on the Marketing Authorization of Pharmaceuticals; and (v) the Regulation on Clinical Trials of Pharmaceuticals.

Guideline on the Cosmetic Product Information File, Responsible Technical Personnel, Product Safety Assessors and Training

On 12 December 2023, The TİTCK published the Guideline on the Cosmetic Product Information File, Responsible Technical Personnel, Product Safety Assessors and Training. The Guideline has been prepared to instruct the responsible person, responsible technical personnel and safety assessors about providing information on the requirements to be included in the cosmetic product information file and the training programs to be organized for the responsible persons who will carry out safety assessments. The main amendments introduced by the Guideline are as follows:

  • A cosmetic product on the market shall be considered safe for human health when used under normal or reasonably foreseeable conditions of use, taking into account the presentation, labeling, instructions and disposal of the product in accordance with consumer legislation and any other data or information provided by the responsible person.
  • Cosmetic products can only be placed on the market if a natural or legal person resident in Türkiye is appointed as the responsible person.
  • The responsible person is the manufacturer for products manufactured in Türkiye and the importer for imported cosmetic products. The distributor is considered to be the responsible person if it places a product on the market under its own brand or makes a meaningful change (excluding translation) to a product already placed on the market.
  • The manufacturer and importer can appoint another natural or legal person as the responsible person with a written agreement. In this case, this person shall be criminally liable and the information of this person shall be included in the company title and address that must be indicated on the packaging.
  • Responsible persons must take all necessary measures to ensure that the cosmetic product to be placed on the market is safe. In this regard, in case of a product assessment that does not comply with the legislation, they must immediately take the necessary corrective measures to bring the product into compliance, withdraw it from the market or recall it, and in cases where the cosmetic product poses a risk to human health, they must immediately notify the TİTCK about any action they have taken.
  • The responsible person must employ and register a responsible technical person ("RTP") with the appropriate level of professional competence and the necessary experience in the product tracking system. The company must continue to employ an RTP throughout the duration of its cosmetic product activities.
  • Chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists and pharmacists can be designated as STEs.
  • A Product Information File ("PIF") must be kept at an address in Türkiye specified on the label of the cosmetic product. The PIF must contain information on the cosmetic product, its characteristics, and the Product Safety Assessment Report.
  • Cosmetic product safety assessment should be carried out by a person who has a diploma or other official proof of competence showing that they have completed a theoretical and practical university education in pharmacy, toxicology, medicine or a similar discipline or another education program whose equivalence is accepted by the TİTCK. Persons with diplomas in pharmacy, toxicology and medicine must attach their diploma samples; other professional groups must attach documents proving that they are competent to prepare a product safety assessment report to the end of this report.

The Guideline is available here (in Turkish).

Decree on the Pricing of Pharmaceuticals

The TİTCK published the Decree Amending the Decree on the Pricing of Pharmaceuticals. The main amendments introduced by the Decree are as follows:

  • The following warehouse profit rates will apply when determining the retail prices of products other than pharmaceuticals:
    • 8% for amounts up to TRY 100 (including TRY 100),
    • 6% for amounts between TRY 100-200 (including TRY 200)
    • 3% for amounts above TRY 200
  • The value of EUR 1 in TRY to be used in the pricing of pharmaceuticals was increased by 25% to TRY 17.5483.
  • The thresholds have been set at TRY 60.51 for the price-protected products and TRY 31.62 for other products in proportion to the change in the value of EUR.
  • When applying the increase, except for non-refundable products, the remaining increases of up to TRY 4 for products in the Detailed Drug Price List with a Sale Price to Warehouse above TRY 55.90 (including TRY 55.90) will be exempt from offsetting during the EUR value update. A periodic EUR value update will be made excluding the remaining increases. In this context, the selling prices of the products to the warehouse will be added to the selling prices of the products without any change in the TRY value.
  • To ensure sustainable health service delivery, the Price Valuation Commission will be able to take ex officio decisions upon the invitation of the TİTCK in case of supply problems that affect or are foreseen to affect the normal life activities of the whole or certain segments of society.

The Decree is available here  (in Turkish), and our legal alert on the pricing of pharmaceuticals is available here for details.

Regulation on the Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices

On 20 December 2023, the TİTCK published the Regulation Amending the Regulation on Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices. The main amendments introduced by the Regulation are as follows:

  • The obligation of health service providers to have the quality control tests of devices performed by medical physicists and quality conformity tests performed by quality conformity organizations may be temporarily suspended by the TİTCK as needed, and the devices for which the obligation is suspended will be announced by the TİTCK.
  • In case the obligation is temporary suspended, the quality control and quality conformity procedures for these devices will be carried out in accordance with national and international protocols, guidelines and standards, and manufacturer criteria.
  • Quality conformity bodies shall not provide services to those who are not included in the authorization certificate of devices that are obliged to have quality conformity tests performed by the quality conformity body.
  • The authorization certificate of the quality conformity body, which is found to have performed quality conformity tests on the devices that are obliged to have quality conformity tests performed by the quality conformity body, outside the scope of the authorization certificate or while the authorization certificate is suspended, and the work certificates of the persons working within its body, will be canceled.
  • The working certificate of the medical physicist who is found to have performed quality control tests on devices that are obliged to have quality control tests performed by a medical physicist, and quality conformity tests on devices that are obliged to have quality conformity tests performed by a quality conformity body, while outside the scope of the working certificate or while the working certificate is suspended, will be canceled.

The Regulation is available here  (in Turkish).

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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.