Promotion of Medicinal Products for Human Use

Contents:

• Scope and Basic Principles of Promotion
• Scientific Meetings
• Satellite Symposium
• Free Samples
• Promotion-Related Responsibilities of Marketing Authorisation or License Holders
• Administrative Sanctions

Promotional activities for medicinal products for human use in Turkey are primarily governed by the Law on Pharmaceutical and Medical Preparations No. 1262, the Regulation on Promotion Activities for Medicinal Products for Human Use, the Application Guide for Scientific Meetings and Product Promotion Meetings within the Scope of the Regulation on Promotion Activities for Medicinal Products for Human Use, and various professional rules.

Scope and Basic Principles of Promotion. Promotion of medicinal products for human use may only be carried out for products for which a license or marketing authorisation has been obtained, vis-à-vis healthcare professionals (“HCP”), including physicians, dentists, and pharmacists. In this context, the following rules should be observed in the promotion of medicinal products for human use:

• Promotion may only be carried out by (i) using promotional materials, (ii) organizing or supporting scientific meetings and product promotion meetings, or (iii) visits by product promotion representatives to HCPs.
• The content of the promotion should be limited to the approved indications of the relevant medicinal product for human use. Furthermore, the content must be current, scientifically verifiable, balanced, and clear, and must not be misleading.
• Promotion shall not be conducted by providing misleading, exaggerated, or unsubstantiated information that may unnecessarily encourage product use or lead to unexpected risky situations or by using images that are attention-grabbing but not directly related to the product itself.
• Promotional activities shall be designed to assist HCPs in forming their own opinions regarding the therapeutic value of the product, and shall include informative and evidence-based medical information about the product’s characteristics.
• It is not permitted to promote products to the public, directly or indirectly, through any type of media or communication channel accessible to the public, including the internet.
• Hospitality and reception events held as part of the promotion of medicinal products for human use should not overshadow the purpose of the event.
• In the scope of the promotion of medicinal products for human use, personal donations to HCPs, whether directly or indirectly, are not allowed. No financial or in-kind advantages may be offered or provided to HCPs.

Scientific Meetings. The purpose of scientific meetings is to provide the participating HCPs with scientific information relevant to their field of expertise or area of responsibility. The following rules apply to scientific meetings:

• The meeting place and time shall not be set in a way that could lead to deviations from the purpose, such as during summer months in vacation areas or New Year’s season.
• Except for international scientific meetings held in a different country each time; it is not appropriate to organize and support conferences (i) in ski resort holiday destinations between 1 December and 1 March, and (ii) in seaside holiday destinations between 15 June and 15 September.
• Except for protocol invitees, individuals other than HCPs may not be invited to scientific meetings, and their expenses may not be covered.
• Expenses related to scientific meetings, such as transportation, accommodation, and registration fees, may be covered only for participating HCPs and only upon obtaining their written consent. In any case, such value transfers must be reported to the Turkish Medicines and Medical Devices Agency (“Agency”).
• Except for meetings attended by a HCP as a speaker or as a researcher presenting an oral or written paper, an HCP may benefit from the support of marketing authorisation or license holders no more than four times in total within the same year. Only two of these four instances of support may be provided by the same marketing authorisation or license holder, and again, only two may be used for meetings held abroad. Expenses of accompanying persons or guests of the participating HCP are not covered within this scope. Participation in scientific meetings organized or supported by the Ministry of Health (“Ministry”) is not considered when calculating the number of participations.
• Marketing authorisation or license holders may provide support for scientific meetings directly to the organization(s) organizing the meeting, not directly to the individuals.
• In support applications, it is mandatory to notify the Agency of the general sponsorship cost and satellite symposium cost (including details of the program, the name of the product to be promoted, the speaker, and any fees paid to the speaker, if applicable).

Satellite Symposium. A satellite symposium is an exceptional session at scientific meetings where product promotion is permitted. The following points should be considered regarding satellite symposiums:

• Organizers of the meeting cannot cover the registration, accommodation, and transportation expenses of the participants from the support provided for holding the symposium.
• Only licensed products may be presented during these sessions.
• The total duration of the satellite symposium should not exceed 25% of the meeting program and each session should be limited to a minimum of thirty minutes.
• For scientific meetings organized with the support of at least two marketing authorisation or license holders, the general sponsorship support provided by each marketing authorisation or license holder may not exceed seven times the gross minimum wage. For scientific meetings organized with the support of a single sponsor, the general sponsorship support provided by the marketing authorisation or license holder may not exceed fifteen times the gross minimum wage. For electronic scientific meetings, sponsorship support for satellite symposium may not exceed ten times the gross minimum wage, while general sponsorship support may not exceed seven times the gross minimum wage.
• The marketing authorisation or license holder may only pay honoraria to speakers at their own satellite symposium; no payments shall be made for other sessions.
• For applications to the Agency for meeting support, applications must be submitted at least fifteen business days in advance for domestic and thirty business days in advance for international meetings; and the list of participants and expenses must be reported within thirty days following the conclusion of the meeting.

Free Samples. The distribution of free samples for promotional purposes shall be carried out in accordance with the following rules:

• The marketing authorisation or license holder may distribute samples free of charge only within the scope of the approved indication, for promotional purposes, in limited quantities, and labelled with the statement “promotional sample, not for sale.”
• Each sample must be at least the size of the minimum packaging unit.
• Samples of products containing narcotics and psychotropic substances cannot be distributed.
• All sample distributions must be recorded and reported to the Agency annually.
• Following the launch of any product, free product samples may be distributed in quantities not exceeding 5% of the total sales volume in the first calendar year; 5% of the previous year’s sales volume in the second calendar year; 3% of the previous year’s sales volume in the third, fourth, and fifth calendar years; and 1% of the previous year’s sales volume after the fifth calendar year.
• A sample of a medicinal product for human use may be provided to the same physician for promotional purposes in a quantity not exceeding four units per year and only for a period of two years.

Promotion-Related Responsibilities of Marketing Authorisation or License Holders. The main responsibilities of marketing authorisation or license holders regarding promotion are as follows:

• For applications to be submitted to the Agency regarding scientific meetings and product promotion meetings, submissions must be made at least fifteen business days prior to the relevant meeting for domestic meetings and at least thirty business days prior to the meeting for international meetings, providing information on the content of the meeting, the list of potential participants, the items of expenditure to be incurred, and the activities to be carried out.
• Promotional activities may be carried out through contracted companies. However, in this case, there would be joint and several liability in respect of the promotional activities performed by the contracted company. All promotional activities carried out through a contracted company must be reported to the Agency.
• Any transfer of value exceeding 10% of the monthly gross minimum wage must be reported to the Agency in detail, in the format specified by the Agency, within the first six months of the following year. For such transfers of value, written approval must be obtained from the relevant HCP or, in other institutions and organizations, from the authorized supervisor.
• The marketing authorisation or license holder company must respond fully to the Agency requests and fulfil its notification obligations electronically.

Administrative Sanctions. If the marketing authorisation or license holder acts in violation of its obligations in relation to promotional activities, the following sanctions may apply as per the relevant legislation:

• If promotional or scientific meeting activities are found to have been conducted in violation of the provisions of the Regulation on the Promotional Activities of Medicinal Products for Human Use:
  1. The Agency issues a warning to the marketing authorisation or license holder.
  2. If the violation is repeated after the warning date, promotional activities for the relevant product may be suspended for up to three months.
  3. If any violation occurs within one year after the date on which the three-month ban on promotional activities is imposed, promotional activities shall be prohibited for one year.
  4. If the non-compliance stems from the product promotion representative, the marketing authorisation or license holder who is generally responsible for promotional activities shall also be held liable. In this case, the marketing authorisation or license holder may be warned by the Authority, or promotional activities for the relevant product may be suspended for up to three months.
• In relation to promotion of medicinal products for human use conducted by the marketing authorisation or license holder, in case of:
  1. promotion of a product through movies, announcements, radio, or any other medium by attributing therapeutic properties that it does not possess or by exaggerating its actual therapeutic effects, or promotion of a product not authorized for over-the-counter sale outside of medical journals, or failing to obtain the Ministry’s prior approval for advertising materials; or,
  2. conduct of promotion online,

the Ministry shall immediately decide to block access. This decision shall be notified to the Information and Communication Technologies Agency.

• Those who promote and sell products using health claims without obtaining permission from the competent authority or in violation of the permission granted shall be subject to administrative fines ranging from approximately TRY 320,000 to TRY 4,750,249 for the year 2025. In case of repetition of the offense, the administrative fine shall be imposed at twice the amount of the previously imposed fine.