Life Sciences 2024 Comparisons

In Turkey, pharmaceuticals and medical devices are regulated separately under specific legislation and regulations.

Pharmaceuticals

The main legislation regulating various aspects of pharmaceuticals products is the Law No 1262 on Pharmaceuticals and Medical Preparations. Based on this law, various regulations and guidelines have been specifically and separately governing many issues such as the clinical trials, manufacturing, marketing authorisation, promotion, sale, supply, distribution, packaging and labelling, and safety of pharmaceutical products. The following regulations and guidelines can be given as standard examples of the main legislation:

• Regulation on the Marketing Authorisation of Medicinal Products for Human Use;
• Regulation on Manufacturing Plants of Medicinal Products for Human Use;
• Regulation on Promotional Activities of Medicinal Products for Human Use;
• Regulation on Pharmaceutical Trade Houses and Products Located in Pharmaceutical Trade Houses;
• Good Distribution Practices (GDP) Guideline for Medicinal Products for Human Use;
• Regulation and Guideline on Packaging, Manuals and Tracking of Medicinal Products for Human Use;
• Regulation on Classification of Medicinal Products for Human Use;
• Regulation on the Safety of Pharmaceuticals; and
• Regulation on Clinical Trials of Medicinal Products for Human Use.

Medical Devices

The main legislation regulating medical devices in Turkey includes the Medical Devices Regulation, the In-Vitro Medical Diagnosis Devices Regulation, and the Medical Diagnostic Devices Used Outside the Body (In Vitro) Regulation, which align with similar EU Directives. Additionally, various regulations and guidelines govern specific issues such as sales, advertisement, promotion and clinical trials of medical devices, including the Medical Devices Clinical Trial Regulation and the Regulation on Sales, Advertisement, and Promotion of Medical Devices.

All legislation and regulations regarding pharmaceuticals and medical devices are issued and enforced by the Ministry of Health (MoH), the Turkish Medicines and Medical Devices Agency (TMMDA) affiliated to the MoH, which are the main regulatory bodies for applying and enforcing pharmaceuticals and medical devices regulations in Turkey.

In practice, decisions of the regulatory bodies can be challenged in the following ways: (i) directly challenge the decision before administrative courts, or (ii) apply to the higher authority, or if there is no higher authority, to the authority that issued the decision. If the second option is preferred and the authority rejects the application, it is still possible to challenge such decision before the administrative courts. There is a 60-day period for filing a lawsuit before administrative courts. In case of an application to the authority that issued the decision or a higher authority, this 60-day period stops, and if no response is given to the application within 30 days, it is deemed to be implicitly rejected by the authority. These challenge procedures also apply to pharmaceuticals and medical devices, including cosmetics, biocidal, traditional herbal medicinal products and homeopathic products. However, although the procedure is the same, the competent authority for food products is the Ministry of Agriculture and Forestry and the challenge procedure must be carried out by applying to the Ministry of Agriculture and Forestry.

According to the Regulation on the Classification of Medicinal Products for Human Use, pharmaceuticals are categorised as (i) prescription products, and (ii) non-prescription products (over-the-counter). Prescription products are also categorised according to the following sub-classes:

• products with replicable and non-replicable prescription;
• products with special prescription; and
• products with restricted prescription.

In addition to this classification, other categories of pharmaceuticals such as original, generic, biosimilar, orphan, allergen and immunological, as well as traditional herbal medicinal products, homeopathic medicinal products and advanced treatment medical products are also defined under other related legislation.

However, medical devices are only divided into four classes, namely Class I, Class IIa, Class IIb and III according to the risk class.

Clinical trials for pharmaceuticals are regulated in the Regulation on Clinical Trials of Medicinal Products for Human Use and clinical trials for medical devices are regulated in the Regulation on Clinical Trials of Medical Devices. There are also guidelines issued on good clinical practices, applications to ethics committees, insurance coverage, safety notifications, archiving principles, import of investigational products, labelling of investigational products and auxiliary human medicinal products. Please note these regulations and guidelines are mostly aligned with similar EU Directives.

To undertake a clinical trial involving pharmaceuticals and medical devices, it is necessary to first secure approval from an ethics committee and authorisation from the MoH. The application for ethics committee approval must be submitted either by the sponsor or a locally based contract research organisation authorised by the sponsor. If the committee determines that the trial’s potential benefits outweigh its risks, approval from the ethics committee is granted. Applications for clinical trials related to pharmaceuticals can be submitted simultaneously to both the ethics committee and the MoH. The MoH reviews the provided documents and issues its decision regarding the trial’s authorisation.

Pursuant to the Regulation on Clinical Trials of Medicinal Products for Human Use and the Regulation on Clinical Trials of Medical Devices, clinical trials are required to be registered in a public database for transparent public disclosure, provided that the confidentiality of personal data is respected. A website has been created by the MoH to fulfil this registration obligation. This database, which is publicly available for clinical trials on pharmaceuticals and medical devices, contains information on the status (approved, finalised or completed), number, type, name and result of the clinical trial in addition to the names of the coordinator centre and physician.

There is no specific restriction against using online tools to support clinical trials. The processing of personal data connected with clinical trial by using online tools is subject to the general provisions of the Turkish Data Protection Law and secondary legislation. A draft Guideline on Digitalisation in Clinical Trials was prepared by the TMMDA on 2 January 2024 to determine the procedure and principles regarding the digitalisation practices used in clinical trials of medicinal products, however, it has not yet come into force.

Personal data and sensitive data obtained from clinical trials is considered as personal data or sensitive data within the scope of the Turkish Data Protection Law and is subject to the restrictions in the law, except in case of processing for research purposes by anonymisation.

Pursuant to the Turkish Data Protection Law and secondary legislation, personal data resulting from clinical trials can only be transferred to a third party or an affiliated organisation where the conditions for transfer and transfer abroad in the law can be provided.

The creation of a database containing personal or sensitive data is subject to the Turkish Data Protection Law. Accordingly, before the personal data or sensitive data is entered into the database and processing is started, informed explicit consent of the patients will be necessary to be obtained.

According to the Regulation on the Marketing Authorisation of Medicinal Products for Human Use, a medicinal product (pharmaceutical) is defined as a product that:

• is presented as having properties to treat or prevent disease in humans; or
• consists of a substance or combination of substances used in or administered to humans for the purpose of correcting, improving or modifying physiological functions or medical diagnoses by exerting pharmacological, immunological or metabolic effects.

Under the Medical Device Regulation, a medical device is defined as any device, apparatus, equipment, software, implant, reagent, material or similar item designed by its manufacturer to be used, alone or in combination, on humans for one or more of the following purposes.

• It does not achieve its primary intended function through pharmacological, immunological or metabolic effects in or on the human body but may be supported by such effects while performing its function. It is specifically intended for:
1. diagnosis, prevention, monitoring, prediction, prognosis, treatment, or mitigation of disease;
2. diagnosis, monitoring, treatment, mitigation, or compensation for injury or disability; or
3. examination, substitution or modification of anatomy or a physiological or pathological process or condition.
• Providing information via in vitro examination of samples from the human body (eg, organ, blood or tissue donations).
• Devices intended for pregnancy prevention or support.
• Products specifically designed for the cleaning, disinfection or sterilisation of medical devices.

Based on these definitions, the entity holding rights to the product or intending to market it must first determine whether the product qualifies as a pharmaceutical or a medical device. In cases where classification is unclear, the marketing party may request scientific advice from the TMMDA to resolve the classification dilemma.

The requirements for granting marketing authorisation (MA) for pharmaceuticals also apply to biological medicinal products. A natural person or legal entity in Turkey must submit an application to the MoH, including a common technical document and relevant information based on the product’s nature. There are no additional specific obligations for granting MA for biological medicinal products beyond this procedure.

Under the Regulation on Marketing Authorisation, the TMMDA assesses MA renewal five years after authorisation, considering the benefit/risk balance. As per the Guideline on Marketing Authorisation Renewal for Medicinal Products, the MA holder must submit a dossier nine months before the five-year expiry, including updated information on efficacy, safety, quality, suspected adverse events, benefit/risk assessments and any variations made. Once renewed, the MA remains valid indefinitely unless the TMMDA requires a further five-year renewal for pharmacovigilance reasons, such as insufficient patient exposure.

Pursuant to the Regulation on the Marketing Authorisation, the authorisation obtained by the TMMDA shall be revoked in the presence of one of the following conditions:

• failure of the MA holder to submit the documents proving the alternative to the reason for the suspension to the TMMDA within six months at the latest from the date of suspension of the MA, or the documents explaining the situation are deemed inappropriate by the TMMDA for the products whose MA has been suspended;
• provided that there is no attachment order or injunction notified to the TMMDA on the MA, upon the request of the MA holder and the approval of the TMMDA;
• in the event that the MA for certain products has been suspended for the following reasons (i) at least one commercial series of a product has not been placed on the market within the first 30 months from the date of MA, (ii) at least one commercial series of a product manufactured in Turkey and previously placed on the market has not been placed on the domestic or foreign markets for at least 30 consecutive months; and for products imported to Turkey, at least one commercial series has not been placed on the domestic market, and they are intended to be placed on the market again, an application is made to the TMMDA for the suspension of the MA with the commitment to place the product on the market within six months at the latest, and the products are not placed on the market within the commitment period.

Pursuant to the Regulation on the Marketing Authorisation, the authorisation obtained by the TMMDA shall be suspended in the presence of one of the following conditions, including but not limited to:

• occurrence of detrimental effects under normal conditions of use;
• determination that the therapeutic effect is absent or insufficient;
• manufacturing with a formula different from the formula which is the basis of the MA;
• change in the formula, dosage, pharmaceutical form, pharmaceutical shape, package and summary of product characteristics based on the MA without the knowledge or approval of the TMMDA;
• failure by the MA holder to take into account scientific and technical advances in terms of production and control methods, and failure to make the necessary changes to ensure that the product is produced and controlled by generally accepted scientific methods, or failure to submit such changes to the TMMDA for approval;
• failure to comply with the provisions of the legislation on packaging information and instructions for use;
• failure to update or notify the short product information and instructions for use;
• failure by the MA holder to respond to the TMMDA’s instructions regarding the product within the period determined by the TMMDA;
• determination that the documents submitted in the application for a product in accordance with the provisions of the Regulation are inaccurate in terms of quality, efficacy or safety of the product, or losing the validity of submitted documents;
• at least one commercial series of a product has not been placed on the market within the first 30 months from the date of MA;
• at least one commercial series of a product manufactured in Turkey and previously placed on the market has not been placed on the domestic or foreign markets for at least 30 consecutive months; and for products imported to Turkey, at least one commercial series has not been placed on the domestic market;
• decision to suspend the MA as a result of the benefit/risk assessment made by the TMMDA for notifications received within the framework of pharmacovigilance practices;
• detection of circumstances requiring suspension of the licence in accordance with the provisions of the Regulation on the Safety of Medicinal Products;
• failure of the MA holder to fulfil its obligations; and
• failure by the MA holder to submit the document showing that the production site(s) based on the authorisation is/are in compliance with the Good Manufacturing Practice Guideline and the Production Site Authorisation Certificate for the active substance production site(s) operating in Turkey in the MA transfer applications.

Medicinal Products

To obtain an MA for a pharmaceutical, a natural person or legal entity residing in Turkey must apply to the MoH with a common technical document and product-specific information. The MoH reviews the application dossier, requests additional data if needed, and must finalise the application within 210 days. Key conditions for granting an MA include product efficacy, safety and compliance with technical and pharmaceutical standards. The issuance of a GMP certificate for the manufacturing site by the MoH is critical, as physical inspections are conducted for both domestic and foreign facilities. GMP certificates issued by EU authorities alone are insufficient for imported products.

Per the Regulation and Guideline on Variations in Marketing Authorised Medicinal Products, packaging or usage information changes linked to MA conditions are classified as Type IA (minor), Type IB (minor) and Type II (major) variations. For Type IA and IB changes, the TMMDA must be notified with required documentation. Type II changes require a formal application to the TMMDA, as detailed in the Variation Regulation annex.

An MA or pending MA application may be transferred to another entity under the Regulation on the Marketing Authorisation. This requires MoH approval and submission of documents such as a court/enforcement decision or a notarised transfer agreement, along with details of the new MA holder, proof of their compliance capabilities, and updated product summaries, instructions and labelling.

Medical Devices

For medical devices, no procedures for the transfer of MA are specifically set forth. Therefore, in case that the MA holder changes, the new holder is required to carry out the procedure for obtaining MA from the very beginning.

Medicinal Products

Pharmaceuticals that are not subject to an MA by the TMMDA cannot be placed on the market. However, there are specific scenarios where pharmaceuticals without an MA can be provided to patients. One notable exception is the named patient sales system, where the MoH might permit the import of unapproved products on an individual basis if prescribed by a physician for patients who cannot be treated with available pharmaceuticals in Turkey, as per the Regulation on Supply of Pharmaceuticals from Abroad and Guideline on Supply Pharmaceuticals from Abroad. Another exception is compassionate use, which allows patients to access pharmaceuticals not yet approved, free of charge, for humanitarian reasons, also on an individual basis.

Medical Devices

There are no exceptions to access the medical devices that are not subject to an MA. Therefore, the procedures required to be followed to place a device on the Turkish market, should be followed, such as conformity assessment procedures, EU declaration of conformity, affixing the CE marking of conformity, and obtaining a certificate of conformity issued by a Notified Body, EUDAMED. In addition, the device must also be registered in the National Product Tracking System (ÜTS), which is an online platform, by the manufacturer/importer/distributor before placing it on the Turkish market.

Medicinal Products

There are numerous ongoing obligations for an MA holder, governed by various regulations. Key obligations of an MA holder to the MoH concerning their MA include:

• manufacturing the product according to the MoH specifications and the scope of the approved MA;
• submitting approvals to the MoH for any changes that reflect scientific advancements, manufacturing and control processes using recognised methods;
• updating the summary of product characteristics and instructions for use, when necessary;
• adhering to critical pharmacovigilance practices obligations (even though pharmacovigilance services may be outsourced, the MA holder is still responsible);
• ensuring product availability on the market; and
• observing all relevant laws and regulations, including those related to promotional activities.

According to the Regulation on Marketing Authorisation, an MA might be granted conditionally, requiring further studies after its issuance, under certain circumstances:

• if the product has limited indications, making it difficult for the MA holder to provide comprehensive evidence;
• if complete information cannot be obtained under the existing scientific data; or
• if gathering such information would violate established ethical principles.

While conditional MAs are rarely issued in Turkey, the MoH may enforce post-marketing commitments, such as mandating Phase IV trials or setting up a controlled distribution system, particularly if the product is of significant importance or poses a safety risk.

Medical Devices

There are several obligations associated with an MA holder which are regulated under the Medical Device Regulation for medical devices. The main obligations of an MA holder before the MoH regarding the possessed MA include:

• establishing, documenting, implementing and maintaining a risk-management system;
• ensuring post-market clinical follow-up;
• keeping technical documentation up to date;
• following the device registration process;
• establishing, documenting, implementing and maintaining a quality management system;
• establishing, implementing, documenting, maintaining and keeping up to date a post-market surveillance system; and
• establishing a system for recording and reporting adverse events and site safety corrective actions.

Medicinal Products

According to the Regulation on Marketing Authorisation, MA applications and the information submitted to the MoH are confidential, and the MoH is obliged to protect this information. However, the MoH periodically publishes a list of MA applications by molecule name. While the applicant’s details are not disclosed, third parties can access information on new applications by molecule name if the list is updated.

Once an MA is granted, the TMMDA publishes a monthly list of authorised products on its website and an annual update in the Official Gazette. This list includes the product name, active substance, MA holder, MA number and MA date. Additionally, the MoH publishes approved product specifications and a product information brochure online. If an application is rejected, the applicant is notified or, if unreachable, an announcement is made on the TMMDA’s website.

The MoH strictly enforces confidentiality regarding information submitted in MA applications. Third-party requests for information, typically from MA holders monitoring potential infringement of their dossiers, were generally denied. However, following a Council of State decision, the MoH is legally required to provide limited information on abbreviated applications based on the requesting party’s MA. This includes the applicant’s name, application number, application date and active substance.

Medical Devices

The confidentiality rule is similarly regulated for medical devices in the Medical Device Regulation and the In-Vitro Medical Diagnosis Devices Regulation. Therefore, the information described above also applies to medical devices.

In Turkey, it is mandatory to have a QR code on pharmaceutical packages in order to ensure that medicines reach the end-user effectively and safely. The Pharmaceutical Tracking System (ITS) was developed to ensure effectiveness in the fight against counterfeit and smuggled medicines by monitoring and tracking medicines through the use of QR codes. Every movement and location of each medicine box marked with a QR code can be tracked from production or importation to sale.

A Product Tracking System (UTS) has also been developed for medical devices to ensure effectiveness in the fight against counterfeit and smuggled devices. Thus, every movement of medical devices can be monitored from production or importation to sale.

The MoH issued a Guideline on Counterfeit, Smuggled or Illegal Medicines to combat the production, import, storage, distribution and sale of counterfeit, smuggled or illegal medicines. In this Guideline, the actions to be taken by the TMMDA, the MA holder company, the pharmaceutical warehouse responsible manager, the pharmacy responsible manager, hospital authorities, pharmaceutical manufacturing sites, physicians and other healthcare personnel, provincial health directorates, the ministry and patients about products suspected to be counterfeit/illegal are regulated separately.

As per the Pharmaceuticals and Medical Preparations Law, if it is determined that the substances used in preparations are not pure or they do not match with the formula given during the MA application, administrative monetary fines shall be imposed. In case the actions may also constitute a crime within the scope of the Turkish Criminal Code, then relevant provisions of specific crimes such as manufacturing or sale of the pharmaceuticals endangering an individual’s health, merchandising of damaged or altered food or pharmaceuticals and manufacturing and merchandising of toxic substances may also be applied.

Within the scope of the Law No 1262 on Pharmaceuticals and Medical Preparations and the Turkish Criminal Code, administrative fines, imprisonment and judicial fines shall be imposed where the counterfeit products and criminal acts are determined to have occurred.

Additionally, customs administrations may take detention, suspension or destruction measures in relation to counterfeit goods subject to customs-approved process or use in the Customs Territory of Turkey, which are suspected of infringing intellectual and industrial rights or which violate these rights.

Medicinal Products

Pursuant to the Regulation on Manufacturing for Medicinal Products for Human Use, a manufacturing plant authorisation certificate is required for medicinal products. To obtain this certificate, an application must be made to the TMMDA with the information and documents specified in the annex of the Regulation. The TMMDA evaluates the application and conducts an inspection to determine whether the requirements of Good Manufacturing Practices are met at the manufacturing plant. The TMMDA finalises the application within 90 days at the latest and decides whether to issue a manufacturing plant authorisation certificate.

A manufacturing plant authorisation certificate must be obtained for activities such as weighing, division, processing, packaging, converting into finished products, related controls and serial release activities of the starting materials used in the manufacturing of medicinal products and/or active substances, including clinical trial products.

The manufacturing plant authorisation certificate is issued for an indefinite period, unless it is revoked by the TMMDA.

Medical Devices

Obtaining a marketing plant authorisation certificate is not required for the medical devices. Conformity Certificates issued by Notified Bodies for manufacturers reflect whether medical devices are manufactured in accordance with the legislation. The Conformity Certificate shall be valid for a period not exceeding five years.

Medicinal Products

Under the Regulation on Pharmaceutical Warehouses and Products in Pharmaceutical Warehouses, pharmaceutical wholesale requires authorisation from the MoH. Entities wishing to operate as pharmaceutical trading houses for activities such as purchase, sale, storage, brokerage, distribution, export and transportation must apply to the provincial or district health directorate. They must provide documentation confirming they meet general conditions, such as employing a responsible manager with a pharmacy degree, hiring required personnel and ensuring the facility meets technical standards. The MoH evaluates applications within 15 days, with a maximum evaluation period of 90 days.

The authorisation certificate is issued for an indefinite period, unless it is revoked by the MoH.

Medical Devices

Pursuant to the Regulation on the Sales, Advertising and Promotion of Medical Devices; natural or legal persons who wish to sell medical devices and be authorised as a sales centre must apply to the Provincial Health Directorate. The Provincial Health Directorate examines the documents within 15 working days, and if there is no deficiency in the application, the directorate conducts an on-site inspection within 45 working days from the date of application. If the sales centre meets the conditions defined in the Regulation, an authorisation certificate is issued by the directorate. The authorisation certificate is issued for an indefinite period, unless it is revoked by the Provincial Health Directorate.

Please see 1.3 Different Categories of Pharmaceuticals and Medical Devices.

Medicinal Products

Several regulations, guidelines and communiqués are enacted for importation and exportation pharmaceuticals. These are:

• Regulation on the Supply of Pharmaceuticals from Abroad;
• Guideline on Import Applications and Marketing Authorisation;
• Application Guideline for Products subject to Prior Authorisation for Exportation and Importation;
• Guideline on Exportation Conditions to be made Except for Pharmaceutical Warehouses;
• Communiqué on Import Control of Certain Products Controlled by the Ministry of Health; and
• Import Control of Substances Subject to Special Permission of the Ministry of Health.

The implementation and enforcement of these regulations are monitored by the MoH, while the Ministry of Customs acts as an inspection mechanism at the point of entry.

Medical Devices

The MoH is the institution applying and enforcing the regulations on the importation and exportation of medical devices, and these activities of medical devices are subject to the Medical Devices Regulation, the In-Vitro Medical Diagnosis Devices Regulation and the Regulation on the Sales, Advertising and Promotion of Medical Devices.

Medicinal Products

Any natural or legal person can be an importer of pharmaceuticals if they are authorised by the MoH. Generally, the compliance with authorisation requirements and obligations similar to those envisaged for the manufacturing activity is required for subjects importing pharmaceuticals (eg, good manufacturing practices certificate and/or manufacturing site authorisation certificate).

Medical Devices

The importer, who is a natural or legal person resident in Turkey, who desires to place a medical device from a third country on the market in Turkey, needs to register as an importer into UTS before placing medical devices, except for custom-made devices, on the market.

However, there are no specific requirements for subjects importing medical devices. Only the importers of medical devices have been required to comply with the obligations regulated in the Medical Device Regulation and the In-Vitro Medical Diagnosis Devices Regulation.

Medicinal Products

In Turkey, only the medicinal products that have been granted a marketing authorisation by the MoH can be imported and placed on the market, upon approval of a permit application made in accordance with the Guideline on Import Applications and Authorisation for Placing on the Market.

Under the Regulation on the Procurement of Medicinal Products from Abroad, the import of medicinal products not authorised in Turkey or authorised but unavailable on the market is allowed for personal use by public institutions approved by the MoH, the Social Security Institution, and the Turkish Pharmacists’ Association. Additionally, in emergency situations, conditional authorisation applications can be made for the import of unauthorised products, provided the requirements outlined in the Regulation on the Marketing Authorisation of Medicinal Products for Human Use are met.

Medical Devices

The importation of medical devices does not require any specific licence or authorisation. However, before being imported and placed on market, medical devices must undergo a conformity assessment demonstrating that general safety and performance requirements are met and must have EU conformity certificates/declarations.

Non-tariff regulations and restrictions for the importation of products are imposed based on the regulatory category of the product, and on their technical descriptions. These are not solely tied to HTS Codes but rather involve compliance with national and EU-harmonised standards. Such as the requirements of batch-specific import permits being issued based on the safety, quality, and efficacy of the product for drugs; and requirements of registry under UTS prior to importation, compliance with CE marking for conformity assessment and additional technical standards set by the Turkish Standards Institution (TSE) that may apply, for medical devices.

The Import Communiqués published annually by the Ministry of Trade outline the product groups and sub-categories subject to non-tariff measures. The TMMDA Guidelines also specify the procedural and documentation requirements for each regulatory category, ensuring public health and safety.

Turkey signed a Free Trade Agreement that covers trade in goods (industrial products as well as fish and marine products and processed agricultural products), trade in services, the protection of intellectual property rights, government procurement, competition and trade and sustainable development with the EFTA States.

Turkey is also a member of the World Trade Organization (WTO) and the Organisation for Economic Co-Operation and Development (OECD).

Under the Decree on Pricing of Pharmaceuticals (the “Decree”) and the Pricing Communiqué (the “Communiqué”), all pharmaceuticals must obtain a price through submission to the MoH. Re-enacted in 2015, the Decree and Communiqué mandate a reference pricing system based on prices in five countries (France, Spain, Italy, Portugal and Greece). Applicants must notify the MoH of any price changes within specified periods. The MoH may also revise prices independently if pricing conditions change.

In practice, applicants evaluate their products based on the relevant rules and submit a price determination request to the MoH under the framework of the Decree and Communiqué. The MoH reviews the application and either approves the requested price or determines a different price if other rules apply. A key issue in the past has been the euro-to-lira exchange rate used for reference pricing, as the MoH had been using the outdated 2009 rate. This was resolved in the 2015 amendments, which now require the MoH to annually revise the euro value based on specific criteria. The approval process is generally consistent, whether the product is a new active substance or a previously approved generic, although various conditions may affect the approved price. Turkey’s reference pricing system is complex, with specific rules and exceptions for different product types, including original products with generics, generics, 20-year products, orphan drugs, allergy products and hospital products. Prices may also be influenced by the prices of other products locally or internationally. For instance, when a generic product enters the market, the price of the original product is reduced to 60%.

Medical devices are not subject to pricing regulation and can be freely priced in Turkey.

Please see 7.1 Price Control for Pharmaceuticals and Medical Devices.

Following the granting of the MA and the price and sales permit by the MoH, the MA holder can sell their pharmaceutical product in the Turkish market. Should the MA holder receive reimbursement approval from the Social Security Institution (SSI), the SSI may also become a buyer, purchasing the product at a discounted reimbursement price rather than the MoH-approved price. Due to public healthcare budget concerns, the SSI has stringent reimbursement rules, resulting in a significantly lower reimbursement price compared to the original price approved by the MoH. Despite this lower price, because the SSI is a major buyer in the healthcare system, MA holders typically choose not to enter the market unless they secure reimbursement approval from the SSI.

The MoH determines the price for products based on reference pricing rules. The SSI considers these parameters when reviewing reimbursement applications and deciding on the reimbursed price of the product. Consequently, pharmaco-economic evaluations, which reflect cost-benefit analyses, are mandatory documents that must be included in the reimbursement application. Occasionally, applicants also present these evaluations to the SSI to provide further details.

In Turkey, physicians have the liberty to prescribe any medication they consider suitable for their patients. However, especially those working in state hospitals and institutions might face political pressure to prescribe lower-priced generics instead of original drugs to reduce public healthcare costs. SSI has set reimbursement rules that impose certain restrictions on physicians’ prescription decisions for patients covered by public social security.

In Turkey, payment for pharmaceutical products can be made by (i) the patient without insurance, (ii) the patient’s private insurer with possible patient contributions, or (iii) the SSI (public insurer) with potential patient contributions. Turkish regulations allow for automatic substitution at the pharmacy level, enabling pharmacists to offer a generic product as a cheaper alternative to a physician-prescribed original product. The MoH and SSI regulate substitution due to its financial impact on the state budget and reimbursement. Pharmacies have discretion to implement substitutions, regardless of whether the prescription is by brand name or International Nonproprietary Name (INN).

Medical apps may be considered as medical devices if the relevant app meets the conditions set forth under the definition of a medical device (please see 3.1 Product Classification: Pharmaceuticals or Medical Devices). In this case, all provisions applicable to medical devices shall also apply to medical apps. Apart from this, there are no special regulations for medical apps.

With the COVID-19 pandemic, the Regulation on the Provision of Remote Healthcare Services has been published. The healthcare facility that desires to provide remote healthcare services must obtain a permit from the MoH. Accordingly, in the healthcare facilities that have obtained an activity permit, healthcare professionals may provide healthcare services through the telemedicine information system produced or approved by the MoH.

Under the Regulation on Promotional Activities for Medicinal Products for Human Use, promoting medicinal products to the public through any media, including the internet, is prohibited. However, advertisements in newspapers or magazines authorised by the TMMDA, announcing that a product has been placed on the market for healthcare professionals, are exempt. Effective measures (eg, disclaimer, password protection or approval mechanisms) should be implemented to prevent the public from accessing any pages meant for promotion to the HCPs.

Similarly, pursuant to the Regulation on Sales, Advertising and Promotion of Medical Devices, it is prohibited to advertise and promote medical devices:

• sold, adapted or applied only in hearing aid centres, custom-made prosthesis and orthosis centres or optician establishments or dental prosthesis laboratories; and
• intended to be used or applied exclusively by healthcare professionals or devices requiring application in medical device sales centres, in any environment including the internet.

Newspaper/magazine advertisements made with the authorisation of the TMMDA, announcements to HCPs that the device has been placed on the market, device notifications made by sales centres on their official websites and advertisements of the types of medical devices given under the annex of the Regulation are outside the scope of this prohibition.

Since 2018, e-prescription practices have been applicable in Turkey. The TMMDA regularly publishes the E-Prescription Drug List showing the products that can be e-prescribed.

Under Law No 1262 on Pharmaceuticals and Medicinal Preparations, those promoting or selling products in violation of the law, or marketing them outside approved indications to encourage improper prescriptions, may face an administrative fine up to five times the total sales of the product in the past year, with a minimum fine of TRY100,000, which will be re-evaluated every year. If the violation occurs online, the Ministry may block access and notify the Information and Communication Technologies Authority for enforcement. Additionally, medicinal products can only be sold through pharmacies, making online sales of medicines prohibited.

While the online sale of medical devices falling within the scope of those referenced in the second paragraph of 8.3 Promoting and/or Advertising on an Online Platform is prohibited, the online sale of medical devices not falling within these categories can only be made by sales centres duly authorised in accordance with the Regulation.

Pursuant to the Basic Law on Healthcare Services, the necessary registration and notification system has been established by the MoH and its affiliated institutions in order to monitor the health status of everyone and to carry out healthcare services more effectively and quickly. Regulations on electronic healthcare records are set out in the Regulation on Personal Health Data.

Health-related data is considered sensitive data in accordance with the Law on the Protection of Personal Data and the Regulation on Personal Health Data, if it consists of any information related to the physical and mental health of an identified or identifiable natural person and information related to the health service provided to the person. Accordingly, for sensitive data, more stringent requirements apply, while the general provisions of the Law on the Protection of Personal Data must also be complied with.

There is no specific regulation in the relevant legislation regarding the transfer and storage of patients’ sensitive data on cloud platforms, but this does not mean that it is not permitted. However, it should be noted that if these cloud platforms are located abroad, the provisions regarding the overseas data transfer will be applied.

In Turkey, patents are primarily regulated by the Industrial Property Law No 6769 (the “IP Law”) and the Regulation on its Implementation. Turkey is a signatory of the Patent Cooperation Treaty (PCT) and the European Patent Convention (EPC). The Turkish Patent and Trademark Office (TURKPATENT) is responsible for granting patents. Key issues in the pharmaceutical and medical device sectors include patent infringement, challenges to patent validity, regulatory approval delays, compulsory licensing and data exclusivity. Patentability requires novelty, inventive step and industrial applicability, but excludes discoveries, scientific theories and certain medical methods. Specific issues include second medical use claims, biotechnology guidelines, regulatory data protection and potential Supplementary Protection Certificates (SPCs).

The patentability of second medical use claims has been debated in Turkey for years, culminating in a significant Supreme Court decision. Turkey, a party to TRIPS and the EPC, follows the principles allowing for the patentability of second medical use claims, especially after the introduction of Article 54(4) and (5) in the EPC 2000. Although the Turkish IP Code is silent on second medical use claims, these patents are recognised and enforced under Turkish law. Prior to the EPC (2000) being implemented in Turkey on 12 December 2007, Turkish courts invalidated second medical use patents based on Article 52/4 of the EPC 1973. However, the 2021 Supreme Court decision affirmed that second medical use claims could be patentable if drafted in Swiss-type claim format, provided they meet novelty, inventive step and industrial applicability criteria. European patents granted by the EPO for second medical uses are validated in Turkey, and the TURKPATENT grants these patents without interruption.

New dosage regimes can also be patentable, if a known pharmaceutical compound is administered in a new, non-obvious dosage regimen that provides a new therapeutic benefit or improved efficacy. Likewise, patents can be granted for new therapeutic applications that target specific patient populations if this new use is novel and involves an inventive step.

Enforcing second medical use patents remains challenging, as unauthorised actions such as production, sale, distribution, import, storage and use of a patented second medical use constitute infringement. The “skinny label” practice, where generic companies exclude patented uses from product labels, complicates proving infringement. European courts emphasise factors like the extent of use for the patented application and measures taken by generics to avoid infringement. Direct infringement occurs if the generic allows use for the patented indication, while indirect infringement involves providing means essential for the patented use. Although second medical use patents are enforceable in Turkey, the lack of case law on specific issues highlights the need for further legal development.

A patent in Turkey is valid for 20 years from the filing date of the application, and this duration cannot be extended. This means that the term of a granted patent in Turkey cannot be lengthened to account for the time spent obtaining pre-marketing regulatory approval.

In Turkey, pharmaceutical or medical device patent infringement encompasses unauthorised activities such as selling, distributing, importing or otherwise commercialising the patented products. It also includes possessing the products for commercial purposes, using them in a way that falls within the scope of the patent claims, or making proposals for contracts related to these patented products. Applying for marketing authorisation itself does not constitute patent infringement. Indeed, pursuant to the Article 85/3 (c), “Acts related to experimental use of the patented invention, including obtaining regulatory approval for pharmaceuticals and the necessary tests and trials”, remain outside the scope. This is called the Turkish Bolar provision, and MA applications are not accepted as an act of patent infringement. Moreover, some courts even consider applications for price approval and the stage where the product is placed on the reimbursement list, made after the completion of the marketing authorisation application, as falling under the Bolar Exemption. However, Article 149/1-b of the Industrial Property Law (effective from 10 January 2017) includes a provision allowing patent holders to request the prevention of potential infringements. This may suggest that “sales permits” might not be covered by the Bolar Exemption. Anyway, once authorisation is granted and the product is launched, any unauthorised activity related to the patented invention could infringe the patent. The threat of patent infringement is also actionable under Turkish law if there is a credible and imminent risk of infringement. To address imminent infringement, the patent holder can seek a preliminary injunction by demonstrating concrete evidence that the infringement is likely to occur, thereby preventing the infringer from proceeding with activities that would result in patent infringement until a final decision is made.

Article 85(3)(c) of the IP Law regulates the Bolar Exemption, which excludes experimental acts involving the patented invention, including pharmaceutical licensing and necessary tests, from patent infringement. The Bolar Exemption aims to ensure that generic drugs can enter the market promptly after patent expiration, preventing an extension of the patent’s protection period. Although the article’s wording limits the exemption to pharmaceutical licensing and related tests, some specialised IP courts and appeal courts have interpreted it broadly. Some courts have rejected requests for evidence determination and preliminary injunctions based on the Bolar Exemption, even when generic products have sales permission, price approval, or inclusion in the SSI’s reimbursement list. Additionally, the exemption covers (i) the preparation of medicines in pharmacies without mass production, solely for fulfilling a prescription, and activities related to such medicines, as well as (ii) actions lacking any industrial or commercial purpose and limited to private objectives.

Compulsory licences can be issued for all patents, including those related to pharmaceutical products, in cases where no licence offer is made and one of the following conditions is met: (i) the failure to utilise a patented invention, (ii) the dependence of a patent’s subject matter on another patent, or (iii) a public interest as determined by a decision of the Council of Ministers. When a compulsory licence is granted, the patent holder is entitled to a reasonable financial fee, which is determined based on the importance of the invention and the specifics of the situation.

Patent infringement proceedings can be initiated by the patentee or the holder of an exclusive patent licence. If the lawsuit seeks damage compensation, the company marketing the patented product in Turkey must also be involved.

Remedies for patent infringement typically include: (i) halting infringing activities, (ii) compensating for damages, (iii) seizing infringing products and related production means, (iv) recognising ownership or destroying confiscated products, and (v) publishing the court’s decision. Preliminary injunctions may also be sought.

A typical infringement lawsuit involves petition exchanges, a preliminary hearing to discuss claims and settlements, case examination if no settlement is reached, expert opinions, hearings and a judgment. First instance court decisions can be appealed to the Regional Court of Justice.

Invalidity can be used as a defence in an infringement action, typically raised as a counterclaim. Courts now often handle both infringement and invalidity claims in parallel, deciding on preliminary injunctions after receiving expert opinions on both.

There is not a patent linkage system, which simply refers to a practice by some national regularity authorities of denying approval of generic drugs that are linked to an existing patent, in Turkey. Thus, the generic companies in Turkey mostly apply for an MA before the expiration of patent in order to enter the market as soon as possible after patent expiration to get more market share and to exploit the first mover advantage. MA is within the scope of Bolar Exemption according to the Turkish Patent Law. Generics push hard to include sale permit and reimbursement stages to Bolar Exemption too, but despite controversies in judgments, courts are inclined to not to include the reimbursement stage in Bolar provision.

For a generic market entrant, clearing the way is not obligatory, though some procedures are available if preferred – eg, one may seek a negative clearance decision from the courts to establish that the generic company’s market entry does not infringe on existing patents.

Under the IP Law, several provisions are in place to combat counterfeiting, including counterfeit pharmaceutical products. Initially, civil remedies similar to those in patent infringement cases are available. These include seeking a court order for (i) obtaining a PI decision and seizing the counterfeits based on the PI decision, (ii) cessation of trade mark-infringing activities, (iii) compensation for damages, (iv) confiscation of the infringing manufactured or imported products and the means used for their production, (v) recognition of ownership or destruction of confiscated products and means, and (vi) publication of the court’s decision against the infringer and notification to the public and relevant parties. Beyond these civil remedies, the right-holder can file a criminal complaint, obtain a search warrant and perform a raid at the counterfeiters’ addresses. This is the fastest and most cost-effective way to stop the counterfeit products; however, it requires a registered trade mark right in Turkey. In the end, an infringer may face imprisonment for a period of one to three years and variable judicial fines. Additionally, trade mark owners can register their trade marks in a customs database, facilitating the identification and seizure of counterfeit pharmaceutical products at customs.

IP Law regulates trade marks in Turkey and does not impose specific restrictions on trade marks for pharmaceutical products. Nonetheless, TURKPATENT tends to apply stringent criteria when assessing similarity and potential confusion between trade marks for pharmaceuticals.

Under Turkish trade mark law, parallel imports are generally permitted. However, for genuine pharmaceuticals, parallel imports are restricted by marketing authorisation regulations. To import pharmaceuticals, obtaining marketing authorisation from the MoH is required, and only the authorisation holder can import the products into Turkey. This excludes other parties who may have legally purchased genuine products from other markets, regions or countries.

Products or their packaging can receive IP protection for trade dress if they exhibit a distinctive character or for design. Such products often achieve acquired distinctiveness over time, as consumers begin to recognise a unique trade dress, design or packaging through extensive usage. TURKPATENT generally requires inherent distinctiveness or clear evidence of acquired distinctiveness, like comprehensive surveys, to grant recognition. As a trade mark, especially in 3D trade mark applications for product shape, TURKPATENT looks for acquired distinctiveness, and they are stricter in these cases. However, they are not very strict in trade mark registration for product packaging; the restriction is seen on product shape, etc. In addition to registering before the TURKPATENT, protection can be pursued under the unfair competition provisions of the Turkish Commercial Code.

In Turkey, under the Regulation on Marketing Authorisation of Medicinal Products for Human Use and subject to IP Law, toxicological, pharmacological and clinical trial data is not required for generic medicinal products if it is fundamentally similar to a reference product already authorised under current legislation, with its data exclusivity period expired. Data exclusivity applies to reference products first licensed after 1 January 2005 in a Customs Union Area country and lasts six years from the initial registration date. For products with patent protection in Turkey, data exclusivity is limited to the patent’s duration.

The data exclusivity provisions apply uniformly to all medicinal products for human use, without distinction between chemical drugs and biologics.

In order for a medicinal product to be commercialised and distributed in Turkey, a marketing authorisation application must be submitted first. During the COVID-19 period, the Guideline on the Application and Evaluation of Conditional Marketing Authorisation (Emergency Use Approval), which regulates the provisions on conditional marketing authorisation, which envisages a shorter marketing authorisation process that can be concluded in a shorter period of time compared to the normal and longer marketing authorisation process, was published and entered into force. Thus, conditional marketing authorisation can be applied for medicinal products to be used in emergencies against public health threats recognised by the World Health Organization or the European Union and accepted by the Ministry of Health. Thus, with conditional marketing authorisation, which envisages a process other than the normal marketing authorisation process, products can be commercialised and distributed rapidly.

The TMMDA published an announcement on the measures to be taken in clinical trials in order to reduce the burden on research centres and ensure the safety of volunteers due to COVID-19. According to the announcement, the following measures have been taken:

• suspension or early termination of the trial when necessary and notification of the situation to the ethics committee;
• identifying the person responsible for the implementation of emergency safety measures;
• notifying the ethics committee of protocol violations due to COVID-19;
• taking measures to keep product stocks higher than usual in case of possible customs barriers or quarantine; and
• limiting visits to clinical trial centres.

In addition, in accordance with the announcement, it was announced that the documents regarding the applications related to clinical trials do not need to be physically submitted to the TMMDA and that these documents can be submitted electronically.

With COVID-19, the Guideline on Application and Evaluation of Conditional Authorisation (Emergency Use Approval) for Emergency Use Approval of Medicinal Products was published by the TMMDA and entered into force. Pursuant to this Guideline, conditional marketing authorisation applications can be submitted to the TMMDA for medicinal products to be used in emergencies against public health threats recognised by the World Health Organization or the European Union or accepted by the MoH. Thus, although comprehensive clinical data on efficacy and safety have not yet been provided, conditional authorisation can be granted if all of the requirements specified in the Guideline are met. Conditional marketing authorisation applications are prioritised by the TMMDA and finalised within 30 days. The conditional marketing authorisation granted by the TMMDA is valid for one year and can be renewed annually.

GMP audit applications for products manufactured abroad and imported to Turkey follow the Guideline on Applications for GMP Audits of Foreign Production Facilities. During the COVID-19 period, the TMMDA suspended on-site GMP audits at foreign facilities but continued file-based and risk-based audits per the Guideline.

GMP certificates initially extended until 30 June 2021, due to halted on-site audits, were further extended to 31 December 2021, without importer applications. This extension applied to products with risk-based audit applications submitted before the certificate’s expiry and those granted GMP certificates through file-based audits referencing these products. Certificates not evaluated by the TMMDA or lacking an on-site audit decision were excluded from the extension.

For domestic production facilities, GMP certificates expired due to inspections older than three years were also extended to 31 December 2021. A subsequent TMMDA announcement extended all GMP certificates valid until 31 December 2021 to 1 June 2024, without requiring importer applications.

With COVID-19, the Communiqué on the Import of Medical Diagnostic Kits was published and entered into force, and the Communiqué stipulated that the TMMDA’s letter of approval was required for the import of reagents, standard and certain immune products that can be used in COVID-19 diagnostics, and thus, the import of medical diagnostic kits became subject to authorisation.

Please see 8.2 Rules for Telemedicine.

In Turkey, there has been no specific intention to issue compulsory licences for COVID-19-related treatments or vaccines, aside from the Emergency Use Approval procedure set out under 11.1 Special Regulation for Commercialisation or Distribution of Medicines and Medical Devices. However, the IP Law provides a legal framework for compulsory licensing in situations of public interest, such as public health crises. The process involves applying to TURKPATENT, showing unsuccessful attempts to obtain a voluntary licence, and granting the licence with reasonable terms and fair compensation for the patent holder. This ensures essential treatments and vaccines are available in exceptional circumstances while respecting patent rights.

No liability exemptions were introduced for COVID-19 vaccines or treatments in Turkey, and the general product liability rules continue to apply.

There was no requisition or conversion of manufacturing sites due to COVID-19 in Turkey.

The procurement of various products such as various vaccines, especially the COVID-19 vaccine, various medicines, diagnostic kits, etc, was made through the State Supply Office in accordance with the State Supply Office legislation.