Medicinal product regulation and product liability in Turkey: overview
A Q&A guide to medicinal product regulation and product liability law in Turkey.
The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability.
For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Turkey: overview.
To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool.
The Q&A is part of the global guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.
The primary legislation is the Code on Pharmaceuticals and Pharmaceutical Preparations (İspençiyari ve Tıbbi Müstahzarlar Kanunu) No. 1262 (Pharmaceutical Code) which was published in the Official Gazette dated 26 May 1928. Various other legislation applies in specific areas.
Secondary legislation (regulations, communiqués and guidelines) regulates the details in relation to each aspect of the pharmaceutical market.
The Turkish state is the main buyer in the pharmaceutical sector due to the broad coverage of public health insurance (with the entry into force of the General Health Insurance legislation, it is planned to include every person residing in Turkey in the health insurance coverage).
The main regulator is the Ministry of Health. It deals with the pharmaceutical sector through its independent institution, the Pharmaceutical Product and Medical Device Institution (Institution). The Institution regulates all aspects of pharmaceuticals including marketing authorisation, production, pricing, import/export, and clinical trials.
The human medicinal product definition adopted by the Ministry of Health and the Institution covers combination products and has been extended to regulate biological products. The legislation and regulation covering human medicinal products also regulates biological and combination products to the extent applicable.
According to the Regulation on Licensing of Medicinal Products for Human Use (Licensing Regulation), medicinal products for human use are defined as any natural and/or synthetic origin active substance or "combination" of substances administered to human beings with a view to treating and/or preventing a disease, making a diagnosis, or correcting or modifying a physiological function. Although the Licensing Regulation does not directly define biological products, they are mentioned throughout the text.
There are additional guidelines issued by the Institution, which along with the Guideline for Biosimilar Medicinal Products provide insight into the definition of which biologicals are products, including those which:
Are produced or extracted from a biological source.
Require some production process and control, along with a combination of physiochemical biological tests to determine the quality of its active substance.
Medical devices and diagnostics are mainly regulated by the:
Regulation on Medical Devices (Tıbbi Cihaz Yönetmeliği).
Regulation on Active Implantable Medical Devices (Vücuda Yerleştirilebilir Aktif Tıbbi Cihazlar Yönetmeliği).
Regulation on In Vitro Diagnostic Medical Devices (Vücut Dışında Kullanılan (In Vitro) Tıbbi Tanı Cihazları Yönetmeliği).
Regulation on Sales, Marketing and Promotion of Medical Devices (Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliği).
Regulation on Clinical Trials of Medical Devices (Tıbbi Cihaz Klinik Araştırmaları Yönetmeliği).
The Ministry of Health and the Institution are planning an offset-like regime specifically for healthcare related public private partnership (PPP) projects, by requiring participants to use or buy Turkish medical devices for certain portions of such tendered projects.
There is no specific regulation of health IT issues and mobile medical applications. However promotional aspects, which are generally the main point of concern, should be evaluated under the regulations on promotional activities for pharmaceuticals and medical devices.
Pricing, state funding and reimbursement
The Code on Fundamental Health Services No. 3359 authorises the Ministry of Health to issue healthcare regulations and establish an equal healthcare system, allowing every person living in Turkey to access it.
The Ministry of Health is in charge of establishing hospitals and public health institutions to provide medical services to the public. These services are funded by the state budget allocated to health services. Reimbursement of health services provided at health institutions such as physical examination, operations or medical tests, are generally covered under the general health insurance supported by personal contributions by patients. Pharmaceuticals prescribed to patients are reimbursed through the reimbursement scheme of the Ministry of Health, supported by personal contributions paid directly or deducted from public officials' wages.
The Higher Education Law No. 2547 grants universities with medicine faculties the authority to establish hospitals. Various university hospitals throughout Turkey have been established through this route.
Private hospitals are also common, especially in cities with a high population. Private health insurance coverage is very low in Turkey compared to state coverage.
The Council of Ministers has authority to set principles to determine the prices of pharmaceuticals by adopting pricing decrees. The Ministry of Health issues pricing communiqués in accordance with the pricing decrees.
The Ministry of Health has a reference price system, in which the prices of pharmaceuticals are set by determining the lowest price among the reference EU countries (France, Spain, Italy, Portugal and Greece). Additionally, price can also be set by taking into account the lowest price in the country of import or the country of batch release. The reference price is determined by taking the active substance and its form/dosage into account.
The price of the reference product is 100% of the reference price until its generic enters the market. In case of generic entry, the price of the reference product is reduced to 60% of the reference price. A generic product can be priced up to 60% of the reference price. Products that are at least 20 years old can be priced up to 80% of the reference price.
At the first pricing phase, the following products are also priced at 100% of the reference price:
Products with an ex-factory price under TRY3.63.
Products that are at least 20 years old with an ex-factory price under TRY6.93.
Certain exceptions apply for specific types of pharmaceuticals, such as orphan drugs.
Certain warehouse and pharmacy profit margins are also added above the price determined through the reference pricing system (along with VAT) to calculate the retail price of a product.
The Euro exchange rate is taken as a basis by the Ministry of Health, which affects the prices of pharmaceuticals significantly. As of 22 February 2016, the exchange rate is increased to TRY2.1166. This has been perceived as a positive development by the Turkish pharmaceutical industry.
The Social Security Institution is in charge of reimbursement of pharmaceuticals. The scope of general public health insurance is very wide in Turkey, so the Social Security Institution buys most pharmaceutical products sold in Turkey through the reimbursement system.
Pharmaceutical products to be reimbursed by the public health system must be registered in the reimbursement list of the SSI. Registering a product in the reimbursement list of the SSI means that additional discounts are applied to prices of products up to 41%, depending on the determined price of the product according to the Health Implementation Communiqué dated March 2013 (as amended from time to time).
The Communiqué on Pricing of Medicinal Products for Human Use sets profit ratios of pharmaceutical warehouses and pharmacies to be applied over the ex-factory prices. Over the counter transactions for prescription drugs are still common, despite legislative efforts against it, therefore direct payment by patients to pharmacies is another source of income.
Legislation and regulatory authorities
Supplemental Article 10 of the Code on Fundamental Health Services No. 3359 of 2011 is the basis for the regulation of clinical trials. Previously, clinical trials had been based on a clinical trials regulation issued by the Ministry of Health. However the regulation was abrogated by the courts, on the ground that such a crucial matter directly linked with human health cannot be legislated through a regulation but has to be on a statutory basis.
In-depth regulation is provided by the Regulation on Clinical Trials of Medicinal Products for Human Use and Biological Products, and the Regulation on Clinical Trials of Medical Devices (Regulation on Clinical Trials). The relevant EU directives on good clinical practices and the Ministry of Health's Good Clinical Practice Guideline are also taken into account in this legislation.
The Institution's Clinical Trials Department is authorised to decide clinical trial related issues, including applications.
Internationally recognised standards are implemented in Turkish clinical trials through the Good Clinical Practices Guideline of the Ministry of Health, based on the World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects 1964.
The sponsor of the clinical trial must apply for authorisation from the Institution. The application dossier must include ethics committee approval. It is possible to apply for authorisation from the Institution and ethics committee approval simultaneously. Local ethics committees are established in university hospitals, training and research hospitals, public hospital associations (kamu hastane birlikleri) and military medicine faculties. There are around 100 ethics committees in Turkey in different regions. Details of them are in the Regulation on Clinical Trials.
The approval of one local ethics committee (of the co-ordinating clinical centre) is sufficient in multi-centred trials. The local ethics committee must give its opinion on:
Procedure and documents used to inform trial subjects.
Consent of trial subjects.
Issues regarding rights, security and well-being of trial subjects.
Under the Regulation on Clinical Trials, the sponsor has the right to conduct the application and trial through a contract research organisation (CRO) domiciled in Turkey. This is a requirement if the sponsor does not have a representative in Turkey.
A clinical trial subject or his/her legal representative must be informed about the trial through an informed consent form. The informed consent must include the (Regulation on Clinical Trials):
Objective of the trial.
Methodology of the trial.
Expected benefits of the trial.
Foreseeable risks, difficulties, and properties of the trial which may be unfavourable to the subject's health or personal traits.
Conditions to conduct the trial.
Subject's right to withdraw from the trial.
The informed consent form must be drafted in an easily understandable manner and give sufficient information. Informed consent form drafts are submitted to the local ethics committees for their review and approval before initiation of a trial, along with the ethics committee approval application.
Under the Regulation on Clinical Trials, a sponsor entity must be present in every clinical trial. The sponsor is responsible for initiating, conducting and financing the clinical trial. The sponsor must have a presence in Turkey or work with a CRO in Turkey.
Under the Regulation on Clinical Trials, it is an obligation by law to protect trial subjects against risks that may arise, by taking out insurance policies on trial subjects. This obligation covers all clinical trials except for Phase IV clinical trials and observational studies.
For medical device clinical trials, insurance covering the medical devices and subjects of the trial must be provided, unless the:
Medical device bears the "CE" mark.
Medical device is used for the purpose designated by its producer.
Relevant ethics committee determines that the benefit-risk ratio of the trial is appropriate.
Under the Regulation on Clinical Trials, the clinical trial must be conducted by a team appropriate to the nature of the trial. A principal researcher must lead the trial team.
In addition, if a new circumstance which could affect the safety of the trial subjects emerges, the sponsor or the researcher must take the necessary safety precautions to ensure the safety of the subjects and notify this to the relevant ethics committee and the Institution. Otherwise, the Institution can suspend the trial. Issues requiring notification are set out in the Good Clinical Practices Guideline issued by the Ministry of Health. When a notification is filed, the ethics committee resolves on such applications in 15 days. The Institution will then issue its decision within 30 days following receipt of the ethics committee decision.
Under the Regulation on Clinical Trials, the sponsor and the researcher must report serious adverse effects occurring during the clinical trial to the ethics committee and the Institution.
Applications for manufacturing medicinal products in Turkey must be made to the Institution.
Under the Regulation on the Manufacturing of Medicinal Products (Beşeri Tıbbi Ürünlerin İmalathaneleri Hakkında Yönetmelik), the following conditions must be met to obtain authorisation for manufacturing medicinal products:
Employing a responsible manager who has the necessary knowledge and experience of medicinal products, who is deemed responsible for the manufacturing process by the manufacturer and the Institution.
Employing a quality assurance and quality control manager.
Establishing a quality control group.
Ensuring that the manufacturing facility complies with the guidelines of good manufacturing practices for medicinal products (global standards in relation to good manufacturing practices are followed in Turkey).
Submitting a non-sanitary enterprise certificate.
Presenting an environmental impact assessment report if necessary.
Restrictions on foreign applicants
There are no specific restrictions on foreign applicants.
Key stages and timing
Article 6 of the Regulation on Manufacturing of Medicinal Products states that manufacturing site permits are granted within 90 days of the application date. The period of 90 days will stop if the Institution requires the applicant to provide additional documentation, and will start again when the applicant provides the documentation.
Fees for obtaining a manufacturing site permit differ depending on the application. The Institution publishes an annual list in Turkish on its website stating the fees for each type of application.
Period of authorisation and renewals
Manufacturing site permits are granted indefinitely, and remain in effect as long as authorisation holders remain in compliance with the application requirements.
Monitoring compliance and imposing penalties
The Institution is entitled to inspect the manufacturing site before or after granting the authorisation. The Institution is not obliged to give any prior notice regarding an inspection. At the end of the inspection, the Institution prepares a report about the manufacturing site's compliance with legal requirements.
The manufacturing permit and/or the responsible manager's authorisation can be partly or completely cancelled or suspended if the manufacturing site does not comply with the Regulation on Manufacturing of Medicinal Products.
Under Article 18 of the Pharmaceutical Code, administrative fines from TRY10,000 to TRY500,000 can be imposed for manufacturing, selling and supplying medicinal products which do not comply with the legislation. These penalties will be doubled on recurrence of the breach.
Authorisation and abridged procedure
An application to obtain marketing authorisation for pharmaceutical products is made to the Institution.
Under Article 16 of the Licensing Regulation, the following criteria are taken into account by the Institution while granting marketing authorisations for human medicinal products:
Whether it is effective in its designated usage conditions.
Whether the pharmaceutical product's safety has been proved.
Whether the pharmaceutical product features the appropriate technical and pharmaceutical properties.
Article 7 of the Licensing Regulation requires legal entities applying for marketing authorisation to employ at least one person with an undergraduate diploma in pharmacy, medicine or chemistry, who can also practise one of these professions in Turkey.
The details and documents to be provided with the marketing authorisation application are set out in Article 8 of the Licensing Regulation. The applicant must prepare a common technical document (CTD) file (OTD, in Turkish) and apply to the Institution. Details about the CTD file are stipulated in guidelines issued by the Institution.
Under Article 8 of the Licensing Regulation, a certificate displaying that the applicant is a representative authorised to import, authorise and sell the medicinal product in Turkey along with its Turkish translation must be provided, if the medicinal product is to be imported into Turkey.
Key stages and timing
The preliminary evaluation period for a marketing authorisation application lasts for 90 days. After completion of the preliminary evaluation period, except in extraordinary circumstances, the Institution must decide the application within 210 days.
The Institution must decide an application within 180 days for pharmaceutical products that:
Would reduce public healthcare expenditure.
However in practice, obtaining a marketing authorisation for a new product in Turkey may take around two years. The procedure is often extended due to the good manufacturing practices (GMP) certificate required by the Institution. According to Article 8 of the Licensing Regulation, a GMP certificate for manufacturing facilities must be submitted with the application. If the manufacturing facility is in Turkey, the Institution issues the GMP certificate. If the pharmaceutical product is manufactured abroad, the GMP certificate is issued by the Institution or recognised by the Institution if it is granted by a foreign authorised institution.
As the Institution does not recognise GMP certificates issued by a range of countries due to its mutual recognition policy, the Institution generally audits and issues the GMP certificate for marketing authorisation applications in Turkey. The workload of the Institution, insufficient number of personnel, and delays due to audits performed abroad mean that marketing authorisation periods last longer in practice.
Fees for marketing authorisation applications differ depending on the application. A detailed list of these fees in Turkish is on the Institution website.
Period of authorisation and renewals
Marketing authorisations for human medicinal products are granted for five years.
To renew the marketing authorisation, information on the medical product's quality, safety and effectiveness, with the necessary pharmacovigilance data, must be submitted three months before the expiration date of the marketing authorisation. Not renewing a marketing authorisation within the five year period does not automatically result in expiry of the marketing authorisation, which remains in force. In practice the renewal procedure for pharmaceutical products is not always followed, and certain products are currently marketed without renewing their authorisations.
Monitoring compliance and imposing penalties
The Regulation on Safety of Pharmaceuticals (İlaçların Güvenliliği Hakkında Yönetmelik) regulates the responsibilities of marketing authorisation holders, healthcare providers, health institutions and the Institution, to ensure the safety of pharmaceutical products with a marketing authorisation or for which a marketing authorisation application is filed.
The Institution is entitled to establish a pharmacovigilance system to collect data regarding the risks of pharmaceuticals. The Turkish Pharmacovigilance Centre (TUFAM) fulfils this position. TUFAM is a member of the World Health Organisation's Program for International Drug Monitoring, and sends data on a regular basis.
Marketing authorisation holders must also establish a pharmacovigilance system, appoint a pharmacovigilance officer from within the company and set up a risk management system.
The Institution can require the marketing authorisation holder to submit its risk management system if a new issue which would alter the benefit/risk ratio of a pharmaceutical arises. It can also require the marketing authorisation holder to submit data which shows that the pharmaceutical retains its benefit/risk ratio.
Under Article 32 of the Regulation on Safety of Pharmaceuticals, the Institution is entitled to inspect the marketing authorisation holder or applicant. On determining a breach, the Institution will allow marketing authorisation holders 15 days to three months to correct their breaches, to comply with the Regulation on Safety of Pharmaceuticals. The marketing authorisation is suspended if the breaches are not rectified in this period. Suspension of a marketing authorisation results in the cessation of the manufacturing and import of the pharmaceutical. If the product is continued to be manufactured and marketed following suspension or cancellation of a marketing authorisation, administrative fines and imprisonment sanctions apply under the Pharmaceutical Code.
The Regulation on Safety of Pharmaceuticals obliges healthcare professionals and marketing authorisation holders to notify any observed adverse effects to TUFAM within 15 days.
Article 24 of the Licensing Regulation stipulates certain responsibilities for holders of a marketing authorisation:
The medicinal product must be manufactured in compliance with the specifications of the Institution.
Any amendment with regard to production and control of the medicinal product must be notified to the Institution.
Any variations to the medicinal product must be notified to the Institution.
Necessary measures must be taken to prevent contamination or infections regarding biological medicinal products.
Any measures taken to reverse the suspension of a marketing authorisation or withdrawal of a medicinal product from the market must be notified to the Institution.
Under Articles 5 and 22 of the Regulation on Safety of Pharmaceuticals, marketing authorisation holders must do all the following:
Notify the Institution of any changes that may change the benefit-risk ratio of the pharmaceutical, by tracking any recalls or limitations issued in other countries in which the pharmaceutical was granted authorisation, and submitting periodical risk/benefit ratio reports.
Establish a pharmacovigilance system and take necessary precautions after receiving information through the system.
Employ a full-time pharmacovigilance officer and inform the Institution of this (this is not required if the duties of the pharmacovigilance officer are conducted by a contracted pharmacovigilance company).
Maintain a main pharmacovigilance folder and submit it to the Institution when required.
Form and maintain a risk management system.
Report any adverse effects observed in Turkey within 15 days to TUFAM.
Archive any possible adverse effects reported in every country where the pharmaceutical is marketed, and any possible adverse effects occurring during post-authorisation safety studies.
Continuously evaluate safety of pharmaceuticals, by preparing periodical reports regarding the benefit-risk ratio of the pharmaceutical.
Under Article 9 of the Licensing Regulation, by applying through the abridged procedure, the applicant is exempt from providing toxicological and pharmacological tests and results of clinical trials. This procedure is used for generic product entry into the market. At least one of the following criteria must be met to benefit from the abridged procedure:
The product is fundamentally similar to a medicinal product which has already been granted a marketing authorisation. Additionally, the holder of the marketing authorisation allows the applicant to use the data in the original application file.
The components of the medicinal product have reasonable activity and admissible reliability settled in medical use.
The applicant's generic medicinal product is fundamentally similar to an original medical product for which the data exclusivity period has expired. This data exclusivity period is six years, starting from the date on which the product received marketing authorisation for the first time in the Turkish-EU Customs Union area, and is only applied for products which received authorisation after 1 January 2005 (and for products which are authorised for the first time after 1 January 2001 and for which no generic application is filed until 1 January 2005).
Parallel imports of medicinal products are not allowed in Turkey. A pharmaceutical product must be manufactured or imported through a local marketing authorisation, or an authorisation of similar nature from the Institution.
However for CE marked medical devices, free circulation cannot be prevented as long as the registration obligation for certain devices is met by registering in the National Database of the Institution (TITUBB).
Restrictions on dealings with healthcare professionals
The Regulation on Promotional Activities of Medicinal Products for Human Use and the Regulation on Sales, Marketing and Promotion of Medical Devices imposes certain restrictions and rules regarding marketing of human medicinal products and medical devices. These are:
Human medicinal products and medical devices which are only intended to be used by healthcare professionals or placed in the Social Security Institution's reimbursement list cannot be advertised to the public.
Promoting human medicinal products and medical devices (for which public marketing is prohibited) is only allowed if it is done through brochures, symposiums, meetings or personal visits to healthcare professionals.
The value of promotional materials/gifts cannot be more than 2.5% of the monthly gross minimum wage determined in Turkey (currently, around TRY40).
It is prohibited to encourage the prescription, use, and recommendation of medicinal products and medical devices, by offering any benefits or incentives to healthcare professionals.
Symposium or conference attendance of healthcare professionals who are sponsored by marketing authorisation or sales (for medical devices) permit holders is also restricted and closely monitored by the Institution, in terms of the amount of sponsorship, the place of the symposiums or meetings, the type of costs covered, and so on. Restrictions on donations also apply.
In addition, Article 29 of the Public Officials Code (Devlet Memurları Kanunu) and Article 15 of the Regulation on Principles of Ethical Conduct of Public Officials (Kamu Görevlileri Etik Davranış İlkeleri ile Başvuru Usul ve Esasları Hakkında Yönetmelik) prohibit public officials from receiving or requesting gifts or any kind of benefits.
Receiving and providing a bribe is a criminal offence under Article 252 of the Criminal Code (Türk Ceza Kanunu). In line with the Criminal Code, apart from sanctions imposed on the briber and recipient of the bribe, special measures are imposed on a legal entity which benefits from a bribe. These include:
Cancellation of official permits (such as a marketing authorisation).
Seizures of financial value, such as property and earnings.
Sales and marketing
Article 28 of the Code on Pharmacists and Pharmacies (Eczacılar ve Eczaneler Hakkında Kanun) requires certain medicinal products to be sold exclusively at pharmacies. These include human medicinal products, traditional herbal products, dietary food and infant formulas.
Article 24 of the Code on Pharmacists and Pharmacies prohibits the sale of medicinal products through the internet or any kind of electronic platform, therefore the sale of medicinal products through the internet, e-mail or mail order is not allowed in Turkey.
Legislation and regulatory authority
The Pharmaceutical Code and the Regulation of Promotional Activities of Medicinal Products for Human Use and its related legislation regulate the advertising of medicinal products. The Institution is the regulatory body.
Advertising to the public of human medicinal products is strictly prohibited in Turkey.
In relation to advertising directed to healthcare professionals, the Pharmaceutical Code prohibits advertisements that overstate and exaggerate the curative properties of medicinal products. Additionally, advertisements of prescription medicinal products can only be published in medical magazines and newspapers addressed to healthcare professionals. The Institution's prior approval must be obtained before publishing such advertisements.
Healthcare professionals and health institutions cannot take part in pharmaceutical product advertising without the prior approval of the Institution. Heavy administrative fines (up to five times the preceding year's total sales value for the product) are imposed on authorisation holders breaching the advertising restrictions.
The advertising of medicinal products over the internet is strictly prohibited in Turkey.
There are general provisions under Turkish laws and regulations which protect personal data but there is no specific legislation that directly governs the collection, processing, transfer and/or protection of personal data.
In February 2016, Turkey ratified the Council of Europe's Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (Convention 108), which has the force of law in Turkey. As a result:
Companies must not store any personal data other than what is required for the legitimate purpose of use of such data.
Companies must not store such data for longer than is necessary.
There is a draft law on protection of personal data, currently pending before parliament. The draft law has been prepared to meet Turkey's obligations under Convention 108 and is in line with EU Directive 95/46/EC on data protection. It is expected to enter into force soon. The draft law is primarily intended to set out principles relating to processing and transfer of personal data, and the authorities and responsibilities of the data protection authority, which will be established following enactment of the draft law.
Currently, personal data is also protected through Article 20 of the Constitution and Article 135 of the Criminal Code, which generally forbid the inappropriate use of personal data. Legislation such as the Regulation on Clinical Trials and related guidelines, and regulations on patient-healthcare professional privilege, also protect sensitive patient data.
Data exclusivity provisions also apply (see Question 11).
Packaging and labelling
Legislation and regulatory authority
The Regulation on Packaging and Labelling of Medicinal Products for Human Use is the main regulation on the packaging and labelling of medicinal products. The Institution is the regulatory authority.
The packaging of a product must contain certain information, which can be summarised as follows (Regulation on Packaging and Labelling of Medicinal Products for Human Use):
Name, dosage and pharmaceutical form of the medicinal product. If necessary, whether the product is intended for babies, children or adults.
Unit amounts, ways of administration and weight or volume amounts of the active substances.
Number of units (tablets, ampoules or bottles) in the package and volume, and weight or dosage number of active substances in pharmaceutical form.
Names of excipients such as colourants, preservatives, antioxidants, flavouring substances and alcohol.
List of excipients known to have certain effects.
Application method and instructions (if necessary).
A special warning stating that the medicinal product must be stored away from children and in its package. Other special warnings (as necessary) must be included.
Storage conditions of the medicinal product.
A special warning regarding the disposal of unused products or waste products, and the appropriate collection system if necessary.
Recyclable symbol, number and abbreviation of the package type.
Manufacturer's and authorisation/permit holder's name and address.
Medicinal product's authorisation or permit number.
Medicinal product's batch number and expiry date.
Medicinal product's expiry date.
Instruction for users if necessary.
Whether the medicinal product is subject to a prescription.
Information on pricing (optional).
Product information on packaging must be in Turkish, and product information in any official language of EU member countries can also be added (Article 14/4, Regulation on Packaging and Labelling of Medicinal Products for Human Use).
The Code on Preparation and Implementation of Technical Legislation in Relation to Products No. 4703 (Products Code) sets the general framework for market monitoring and audits to be performed on any product put on the market in Turkey, and can be regarded as the main legislation regarding product safety.
A draft Code on Product Safety and Technical Regulation has been prepared to replace the Product Code but has not been put into effect.
The general provisions of the Code of Obligations and the Consumer Protection Law also apply to issues regarding medicinal product safety and liability.
Under the Recall Regulation (Geri Çekme Yönetmeliği), the Institution is the key regulator in the recall of medicinal products. Article 5 of the Recall Regulation provides the Institution with powers to do the following after it detects a defective medicinal product on the market:
Demand information or an explanation from the responsible company.
Evaluate the explanations of the responsible company and decide on the class and level of the recall.
Follow up on the status of the recall.
Halt production or import of the defective medicinal product if necessary.
Finalise the recall process carried out by the responsible company, and handle the procedures for closing the recall file.
Take necessary precautions if it deems that the responsible company is not competent in the recall process.
Authorise the medicinal product's release into the market if it deems that the defect has been corrected.
Issue a second recall if it deems necessary.
The Institution can impose penalties for non-compliance (see Question 20).
The Regulation on Safety of Drugs regulates the mandatory provisions and responsibilities of marketing authorisation holders, healthcare providers, health institutions and the Institution, to ensure the safety of pharmaceutical products (see Questions 9 and 10).
For mandatory requirements regarding pharmacovigilance, see Question 10.
The responsible company must (Article 6, Recall Regulation):
Implement a recall procedure.
Notify the Institution regarding any medicinal product which is or could be defective.
Conduct the recall process.
Provide explanations to the Institution regarding a possible recall.
The manufacturer of the defective medicinal product must indemnify the relevant parties for damage incurred due to the defective product and recall (Article 16, Recall Regulation).
The Institution can impose penalties specified under the Product Code in case of breaches regarding product safety and recall issues. The Criminal Code and Code on Misdemeanours may also apply. The marketing authorisation of a pharmaceutical product which was not recalled despite a recall decision of the Institution or does not have its recall file closed for three years will be suspended. If the recall file still remains open after a year, the suspension of the marketing authorisation will result in cancellation of the marketing authorisation.
The following contractual relationships are formed in a typical supply chain of a pharmaceutical product:
Manufacturer and pharmaceutical warehouse.
Pharmaceutical warehouse and pharmacy.
Pharmacy and consumer.
These relationships may weaken and prevent a consumer's direct contractual claims against the manufacturer of the pharmaceutical product under this route.
Under Article 49 of the Code of Obligations, a person damaging another person with a fault based and unlawful act must compensate this damage. To claim in tort, the following elements must be established:
An unlawful act.
Fault of the perpetrator.
Causal link between the unlawful act and the damage.
It is possible for a consumer to claim against the manufacturer of the pharmaceutical product in tort. However:
The prescription period for tort claims is just two years, and that may be an obstacle to bring a claim.
It is common for a civil court to rule on its lack of jurisdiction, based on consumer court jurisdiction in product liability claims.
Pharmaceutical product liability claims are also complex for consumer courts, since they generally deal with basic claims.
Product liability (statute)
Under the Regulation on Liability of Damages Raised from Defective Products (Ayıplı Malın Neden Olduğu Zararlardan Sorumluluk Hakkında Yönetmelik), a manufacturer/importer of a defective product is liable for death, injury or property damage caused by a defective product, as a form of strict liability.
However, Article 7 of the Draft Code on Product Safety and Technical Regulation, which is not in force, enables the manufacturer/importer to be liable only if the product does not comply with product safety measures (unlike the more strict condition for a product to be defective required by the current regulation).
The manufacturer and the market authorisation holder which produce or import a defective pharmaceutical product are liable in tort and in product liability. However in practice, physicians are pursued for complications caused by defective medicinal products through malpractice lawsuits. This is mainly because physicians are the first point of contact for patients, and patients are not usually able to distinguish malpractice claims from product liability claims.
There are standard types of defences which can be brought under each type of claim, for example, tort claims or product liability claims, alleging that the conditions required for bringing such claims are not present for the claim. However, the application of procedures under malpractice claims (which is the general way preferred under Turkish law) has a defence in favour of the defendant and an obstacle for the claimant (see Question 22).
It is common for courts to appoint the Forensic Medicine Institution (Adli Tıp Kurumu) as an expert in malpractice lawsuits, and it takes around two years for the Forensic Medicine Institution to submit its expert opinion report due to its workload. It is also common for the Forensic Medicine Institution's Board, which is formed by physicians, to conclude its expert opinion report in favour of the defendant physician. These issues are much criticised in practice.
For claims arising from contractual liability, the limitation period is two years from the transfer of the product from the seller to the buyer. The seller may undertake a longer period. The two year limitation does not apply if the seller sells the product under gross fault.
For liability claims in tort, the limitation period is two years from the date when the claimant becomes aware of the damage and identity of the person liable for the damage. Claims become time barred after ten years.
Under Article 12 of the Consumer Protection Code, a two year limitation period applies (a longer term can be determined by legislation or by the parties) starting from the date the consumer receives the defective product. No limitation applies if the defect is hidden due to gross fault or fraud.
Class actions are not allowed under Turkish law. However under Article 113 of the Civil Procedure Code, associations and other legal entities can bring lawsuits to protect their members' interests. Therefore it is possible for consumer associations to file class actions on behalf of their members for product liability claims.
For contractual liability, under Article 227 of the Code of Obligations, the consumer can claim the following remedies from the seller:
Cancel the contract by returning the product.
Claim a discount on the purchase price.
Claim repair of the product free of charge, if the repair does not have an excessive cost.
Request replacement of the product with a non-defective product, if possible.
In tort, the consumer can claim reimbursement for both material and immaterial damages. The court will determine the damages incurred by the consumer, and rule on the amount sufficient to reimburse the damages.
Punitive damages are not allowed in Turkey.
Apart from minor revisions to the current legislation, no new proposals for reform are expected in the short term. However, an offset regime to be applied specifically in healthcare PPP projects may be put in place by the Ministry of Health.
The latest amendment was the Promotion of Medical Products for Human Use Regulation (published in the Official Gazette dated 3 July 2015 and numbered 29405) adopted by the Institution in July 2015. Although this is mostly similar to the abrogated Promotion of Medical Products for Human Use Regulation, the new regulation adds more detail on the requirements on product representatives, and lessens the limitations on the participation of physicians in scientific and promotional events organised by marketing authorisation holders.
Turkish Ministry of Health
Description. The official website. Contains a broad range of legislation regarding the health sector. It includes up-to-date and official news, announcements and general information. There are no translations of legislation available. The English information featured in the website is potentially out of date.
Turkish Medicines and Medical Devices Institution
Description. The official website. Contains up-to-date legislation and information related to medicinal products, medical devices and cosmetic products. It includes English translations of a few regulations. Translations are for guidance purposes only and are potentially out of date.
Official legislation website of Turkey
Description. The official governmental website, which contains in Turkish all applicable legislation and amendments made to it.
Kayra Üçer, Partner
Hergüner Bilgen Özeke Avukatlık Ortaklığı
Professional qualifications. Georgetown University Law Center (LL.M., 2000); Marmara University School of Law (Law Diploma, 1998)
Areas of practice. Corporate and commercial matters, including mergers and acquisitions, labour law, compliance law and anti- corruption practices.
Languages. English, French
Istanbul Bar Association.
Saint-Joseph Alumni Association.
Georgetown Alumni Association.
Transparency International Association.
Turkish Corporate Governance Association.
President of ILI, the Istanbul International Law Association.
Gülbin Olgun, Associate
Hergüner Bilgen Özeke Avukatlık Ortaklığı
Professional qualifications. London School of Economics and Political Science (LL.M., 2015); Galatasaray University Faculty of Law (Law Diploma, 2009)
Areas of practice. Special focus on pharmaceutical and life sciences areas and intellectual property law; corporate and commercial matters, including mergers and acquisitions; labour law; compliance law and anti- corruption practices and white-collar crime.
Languages. English, French, Spanish
Professional associations/memberships. Istanbul Bar Association; Galatasaray University Alumni Association.
Mert Bölükoğlu, Associate
Hergüner Bilgen Özeke Avukatlık Ortaklığı
Professional qualifications. Istanbul Bilgi University Faculty of Law (Law Diploma, 2014)
Areas of practice. Corporate and commercial matters, including mergers and acquisitions and labour law.
Languages. English, German
Professional associations/memberships. Istanbul Bar Association; American Collegiate Institute Alumni Association.