Hot-button legal issues around marketing, manufacturing, packaging & labelling and advertising in Turkish pharma. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for USD 99.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

Under Turkish laws and regulations, a registration process is required for a drug, biologic medicinal product, over-the-counter medications and any other medicinal products that are used to treat, diagnose, and prevent diseases to be released at the market. The registration process is outlined under the Regulation on the Registration of Medicinal Products for Human Use. Unlicensed or unregistered drugs and other medicinal products cannot be released or marketed (Article 5, Licensing Regulation on Human Medicinal Products).

Real and legal entities of Turkish residency must apply to the Ministry for authorization with additional forms and documents (Article 6, Licensing Regulation on Human Medicinal Products). Applicants may be required to fulfil certain criteria to apply for registration.

Applications undergo a preliminary examination by the Ministry regarding fulfilment of requirements (Article 13, Licensing Regulation on Human Medicinal Products). License applications which meet preliminary requirements will then be subject to a broader examination which takes approximately 210 days.

If the application is found satisfactory, marketing authorization is granted for the concerned product and the applicant will be notified. Products which the Ministry approves are then published in the Official Gazette along with the name and surname of the marketing authorization holder and the authorization number.

The rules and principles regarding the marketing and advertisement of medical devices are regulated under Regulation on the Sales, Advertisement and Publicity of Medicinal Devices.

To be authorized as a medical device sales centre, real and legal entities must submit a petition to the relevant Provincial Directorate of Health (“Directorate”) providing their commercial information. The Directorate reviews the petition within 15 business days of the application (Regulation on the Sales, Advertisement and Publicity for Medicinal Devices. If the application documents are complete, it will conduct an on-site examination at the intended sales centre within 45 business days of the application. The Directorate issues a certificate of authorization if the sales centre meets the required conditions. The Directorate will notify the applicant if its on-site examination reveals failures to meet the necessary conditions. The applicant may correct the deficiencies and apply for the authorization certification within 45 business days of the notification.

Medical devices that are required to be used or operated by health care professionals cannot be advertised through any means of public media and communication tools (Article 15, Regulation on the Sales, Advertisement and Publicity of Medicinal Devices).

The Directorate inspects sales centres every two years. The Directorate can order a centre to immediately cease or terminate all sales activities, promotion and advertisement. If the unlawful or inappropriate situation is not remedied by the centre within given times, activities can be ceased altogether. (Article 27, Regulation on the Sales, Advertisement and Publicity of Medicinal Devices).

2. What is the authorization process for the marketing of generic versions of these products?

A shortened authorization process exists for generic versions of already licensed original drugs if the original product’s data exclusivity period has expired (Article 9(3), Licensing Regulation on Human Medicinal Products). A registration application for a generic product does not constitute a violation of the original authorization holder’s patent right. For generic products, applicants are exempt from conducting and providing the results for mandatory toxicological and pharmacological tests and clinical research. The data exclusivity period for original products is six years for products which were either:

• Granted authorization for the first time after 1 January 2001 from a Turkish Customs Union country and no generic registration application were filed in Turkey before 1 January 2005; or
• Granted authorization for the first time after 1 January 2005 from a Turkish Customs Union country.

3. What are the typical fees for marketing approval?

Applicants for drug or other medicinal product licenses must pay various fees, such as analysis, scientific research and assessment fees. The amount of each fee differs annually, with the tariffs announced on the Turkish Medicines and Medical Devices Agency website.

2018 tariffs can be found here (in Turkish): https://www.titck.gov.tr/FiyatTarifesi

The authorization process for a medical device sales centre requires applicants to pay several different fees:

• Medical device sales centre certificate of authorization fee (TRY 251, as of 1 January 2018),
• Additional fees for permits regarding directors and special personnel.

Detailed information regarding authorization and renewal fees of medical device sales centres can be found on the Provincial Directorate of Health website (in Turkish): http://istanbulism.saglik.gov.tr/

4. What is the period of authorization and the renewal process?

The registration process is outlined in the Licensing Regulation on Human Medicinal Products. Accordingly, the Ministry conducts a preliminary investigation within 30 days of receiving an application. If the Ministry finds that the application does not meet requirements, the applicant is given an additional 30 days to fulfil the requirements. The Ministry conducts a second preliminary investigation within 30 days of receiving a revised application.

After the preliminary investigation, applications fulfilling all the requirements set under this Regulation are proceeded by the Ministry for further investigation which shall not exceed 210 days.

If the Ministry rejects the application, the applicant can object to the decision in writing within 30 days of receiving the rejection. The Ministry must consider the objection within 90 days.

Licenses are renewed every five years (Article 21, Licensing Regulation on Human Medicinal Products). License holders must submit documents and information regarding changes and pharmacovigilance data to the Ministry at least three months before the end of the fifth year.

5. What are the requirements, if any, for post-approval pharmacovigilance?

Marketing authorization holders have an ongoing responsibility to monitor the effects of their products and to assure the safety of their customers after obtaining marketing authorization and releasing the product to the market. The responsibilities of market authorization holders regarding their authorized medicinal product are outlined in detail (Article 24, Licensing Regulation on Human Medicinal Products).

Marketing authorization holders’ responsibilities in relation to the safety of their products are also outlined in detail (Article 5, Regulation on the Safety of Medicinal Products).

Detailed and technical information can be found in English here: https://www.titck.gov.tr/PortalAdmin/Uploads/UnitPageAttachment/lWcsQPio.pdf

6. Are foreign marketing authorizations recognized?

Foreign marketing authorizations are not recognised in Turkey. If a medicinal product is licensed abroad and is imported or manufactured in Turkey, a Turkish marketing authorization is still required. Applicants for marketing authorization must submit original and up to date copies of a medicinal product’s (Article 8, Licensing Regulation on Human Medicinal Products):

• Summary of characteristics,
• Patient information leaflet and packaging samples (with Turkish translation).

7. Are parallel imports of medicines or devices allowed?

Imports of medicinal product are strictly regulated in Turkey and parallel imports of medicinal products are not allowed. The Code on Pharmaceutical and Drugs regulates importing, exporting and manufacturing medicinal products, including penalties for non-compliant products or activities.

Marketing authorization must be obtained from the Ministry before a medicinal product is (Article 3, Code on Pharmaceutical and Drugs):

• Released into the Turkish market (products manufactured in Turkey); or
• Imported or exported (products manufactured outside Turkey).

An importer must have marketing authorization to import medicinal products into Turkey.

In principle, marketing authorization for a particular medicinal product can be held by only one entity. However, two or more companies may agree to market and sell the same medicinal product under two different brand names by entering into a co-marketing agreement. Therefore, a product can be subject to co-marketing if the authorized company gives authorization to another company.

Accordingly, parallel imports of medicinal products are legally impossible. Importing medicinal products into Turkey without local market authorization constitutes smuggling (Article 19, Code on Pharmaceutical and Drugs) which is subject to imprisonment for between one and five years.

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

MEDICAL DEVICES

The Regulation on Sales, Marketing and Promotion of Medical Devices outlines restrictions, clear rules, and procedures for marketing medical devices in Turkey:

• Medical devices cannot be advertised to the public if they can only be operated by healthcare professionals or by parties on the Social Security Institution’s reimbursement list. Promotion of these medical devices can only be made to healthcare professionals and technical personnel who work for medical devices in the healthcare institutions and organizations.
• Promotion can be made through brochures, symposiums, meetings, or personal visits. Regulation on Sales, Marketing and Promotion of Medical Devices outlines detailed rules on permitted promotional activities.
• The value of promotional materials must be worth less than 2.5% of the monthly minimum wage in Turkey.
• An authorized sales centre (“Sales Centre”) is a centre for distribution and sale of medical devices. To become an authorized medical device sales centre, an applicant must submit the documents listed in the Medical Device Marketing and Sales Regulation to the local health authorities. If a Sales Centre wishes to sponsor a healthcare professional or medical device personnel to attend a scientific event or meeting, it must provide details to the Authority. No such event or meeting can be held or sponsored at coastal or ski centres during high-season, except for international congresses regularly held in different countries. Sponsorship of participation in scientific events or meetings is subject to certain conditions (from 15 May 2015 onwards):

• • • Meetings must only target healthcare professionals’ or medical device personnel’s areas of expertise;
    • Healthcare professionals and medical device personnel can be sponsored for a maximum of three events per year, two events by the same sales centre per year, or two events outside Turkey per year;
    • Sponsorship must go directly to the hosting organisations, not to the healthcare professional or medical device personnel.

• • • It is prohibited to give benefits or incentives to healthcare professionals or medical device personnel with the intention of incentivising prescription, use, purchase or recommendation of a particular medical device.
    • Donations can be made to healthcare professionals. A Sales Centre can donate to public or non-profit healthcare institutions if several conditions are met. These include prior approval from the authorities and properly recording the donation in the Sales Centre’s accounts and records. The donation must not influence decisions on public tenders or constitute unethical behaviour regarding the sale of medical devices.
    • Donations must be intended for general use by the recipient entity, not a specific individual.
• Free samples of medical devices are permitted, provided they meet certain technical requirements, including:

• • • Packaging must include the phrase “free promotional sample, not for sale”; and
    • The sample’s value cannot exceed 2% of the medical device’s turnover for the previous year (not applicable for the first year which a product enters the market).

MEDICINAL PRODUCTS

The Regulation on Promotion of Medicinal Products for Human Use regulates promotion of medicinal products for human use. It generally includes similar provisions to the Regulation on Sales, Advertising and Promotion of Medical Devices.

The Regulation on Promotion of Medicinal Products governs the relationship between pharmaceutical companies and healthcare professionals:

• Promotion of the medicinal products can only be made to the physicians, dentists and pharmacists. Promotion to the healthcare professionals is made by (Article 5, Regulation on Promotion of Medicinal Products for Human Use):
  • Using the promotion materials to the physicians, dentists and pharmacists,
  • Organizing scientific meetings and product promotion meetings,
  • Visiting physicians, dentists and pharmacists through the product promotion representatives.
• Companies must not promote prescription of their products by offering any kind of benefit to healthcare professionals (Article 6/10(c), Regulation on Promotion of Medicinal Products for Human Use).
• The value of gifts given by companies to healthcare professionals is restricted to 2.5% of the monthly minimum wage in Turkey (Article 8, Regulation on Promotion of Medicinal Products for Human Use).
• Healthcare professionals are prohibited from asking for benefits (Article 6, Regulation on Promotion of Medicinal Products for Human Use).

Restrictions also apply to marketing practices for healthcare organizations and individual medical practitioners within the context of media and broadcasting. Commercial broadcastings of pharmaceuticals and prescription medical treatments are banned according to:

• Article 11/2 of the Establishment of Radio and Television Enterprises and their Media Services Law numbered 6112, published in the Turkish Official Gazette dated 3 March 2011 and numbered 27863 (“Radyo ve Televizyonların Kuruluş ve Yayın Hizmetleri Hakkında Kanun”),
• Article 12/b of the Regulation on Broadcast Service Procedures and Principles published in the Turkish Official Gazette dated 2 November 2011 and numbered 28103 (“Yayın Hizmeti Usul ve Esasları Hakkında Yönetmelik”).

The Public Servants Law numbered 657 (“Devlet Memurları Kanunu”) prohibits public servants from receiving or requesting gifts or credits from those for whom they perform their duties, with the purpose of taking advantage of their duties (Article 29). All employees working in the public sector are deemed to be public servants, including employees of public hospitals.

According to the Turkish Criminal Code numbered 5237, bribery is a crime. The Criminal Code defines bribery as occurring where any person secures directly (or through other persons) an undue advantage to a public official such as an employee of the Ministry (or another person indicated by the public official) to perform or not to perform a task related to his or her duty (Article 252, Criminal Code).

The Turkish Criminal Code equally punishes public official who receives the bribe and the person who provides the bribe. If a legal entity receives an unfair advantage as a result of bribery, the legal entity is also subject to, for example, cancellation of official authorizations (such as marketing authorization), seizure of property, or seizure of proceeds of crime. Turkish laws in this respect still apply if a Turkish citizen commits bribery outside Turkey. Therefore, healthcare professionals involved in illegal promotion of pharmaceuticals abroad will still be subject to the sanctions indicated in the Turkish Criminal Code.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

According to the Regulation on the Manufacturing Plants of Human Medicinal Products, natural and legal entities must apply to TİTCK, with the necessary information and documents. The applicant will be granted a manufacturing place permission document after supervisors make an inspection. Since Turkey is a member of Pharmaceutical Inspection Co-operation Scheme (PIC/S), applicants must hold a Good Manufacturing Practice Certificate (GMP) / Manufacturing License.

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?

According to current legislation, almost all specifications required for local manufacturing are compatible with the European Medicines Agency, as regulated under the Regulation on the Manufacturing Plants of Human Medicinal Products. It was drafted in accordance with the legislation of the European Union by taking into account the:

• Directive No. 2011/83/ EC on human medicinal products,
• Directive No. 2001/94/ EC on the principles and guidelines for Good Manufacturing Practices of human medicinal products and clinical research products,
• Directive No. 2011/62 on preventing the entry of counterfeit medicinal products into the legal supply chain.

11. What is the inspection regime for manufacturing facilities?

Manufacturers which are within the scope of the Regulation on the Manufacturing Plants of Human Medicinal Products are subject to inspections by TİTCK, which may occur with or without prior notice. TİTCK may take samples of medicinal products for human use and active substances. TİTCK can also inspect a manufacturing site before granting the manufacturing permit, or at any later time it deems necessary, without being required to provide prior notice. Any documents or records related to manufacturing, quality control, or quality assurance can be examined during the inspection. TİTCK prepares a report indicating whether the site complies with the Regulation on Manufacturing of Medicinal Products’ requirements.

Manufacturers, laboratories that provide contractual analysis services for human medicinal products, and importers are subject to routine inspections within TİTCK’s risk-based evaluation program. Where necessary or due to a suspicion of any non-conformity, TİTCK will carry out inspections of imported active substances and of manufacturing facilities of auxiliary substances or of storage and distribution places.

The manufacturing permit or the responsible manager’s authority can be partly or completely cancelled or suspended (on a temporary or permanent basis) if the site fails to comply with the Regulation on Manufacturing of Medicinal Products’ requirements.

Administrative fines range from TRY 10,000 to 500,000 for manufacturing, selling, and supplying non-compliant products (Article 18, Code on Pharmaceutical and Drugs). Breaches of advertising restrictions attract administrative fines (starting at TRY 100,000), as well as potential sanctions from the Information and Communication Technologies Authority (for online advertising). Administrative fines double for repeat offences.

Persons who manufacture drugs which endanger human life or health are also subject to imprisonment of between one and five years, as well as punitive fines (Article 187, Criminal Code numbered 5237). Sanctions increase by one third where the crime is committed by a physician, pharmacist, or within the scope of performing a profession subject to public authority permission.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Turkey became a member of the Pharmaceutical Inspection Co-operation (“PIC/S”) on 1 January 2018. PIC/S has conducted several inspections in Turkey to evaluate and approve the country’s membership application. However, PIC/S does not inspect pharmaceutical companies and does not certify companies.

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

The Ministry’s Regulation on the Labelling, Package Leaflet and Tracing of Human Medicinal Products outlines the requirements for storage, packaging and handling of medicines and what information must be inserted on the inner and outer packages of medicinal products. It also lists the minimum requirements for usage instructions and labels for medicinal products.

Packaging of medicinal products which contain radionuclides must be labelled in accordance with the regulation regarding the Turkish Atomic Energy Agency, as well as other relevant international legislation.

Please see below Question 14 for mandatory labelling content.

14. What information must be included in medicine and device labeling?

Labels should include (Article 5, Implementing Regulation on the Labelling, Package Leaflet and Tracing of Human Medicinal Products):

• The product’s name, dosage and pharmaceutical form,
• If the product contains up to three active substances, the international non-proprietary name (INN), or common name (if no INN exists),
• Whether the product is intended for babies, children, or adults (if applicable),
• The unit amounts or administration routes and the weight or volume amounts of the active substance’s pharmaceutical form (indicated by the INN or common name),
• The number of units in the package, such as number of tablets, ampoules, or bottles,
• The volume, weight, or dose number of active substances in pharmaceutical form (if these cannot be regarded as net content),
• Excipients such as colourings, preservatives, antioxidants, flavouring substances, and alcohol must be indicated by name,
• Excipients known to have an apparent effect must be presented as a list (qualifying excipients are specified in the Packaging and Labelling Regulation on Medicinal Products). However, all excipients must be indicated if the product is injectable, applied locally, or is an ocular preparation,
• Method of use and route of administration (if necessary) must be indicated,
• Other special warnings relating to the product must be indicated (where applicable),
• Storage conditions and special storage conditions for the product (if any),
• Special warnings relating to the disposal of unused products or waste of products and, where necessary, the appropriate collection system must be indicated,
• Packaging must include the recyclable symbol, number, and abbreviation of the package type,
• The registration or permit holder’s name and address,
• The name of the company marketing the product which has been authorized to represent the registration or permit holder (optional),
• Manufacturer’s name and address,
• The product’s registration or permit number,
• The product’s batch number,
• The product’s expiry date,
• Instructions for users (if the product is used for self-medication purposes),
• Warnings stating:

• • • “keep out of reach of children”;
    • “do not purchase packages that have been cut or opened”;
    • “read the package insert before use”;
    • “consult your physician if any undesirable effects appear”;
    • other warnings issued by the Ministry.
• Information about whether the product requires a prescription or not,
• A two-dimensional barcode (as a secondary identifier) and legible information relating to the content of the barcode,
• The product’s barcode (optional),
• The product’s price (optional).

Where a product has both inner and outer packaging, most of the information listed must also be included on the inner packaging. Additionally, all the information above must be displayed in a readable, easily understandable and non-deletable way. Information must be in Turkish on the outer and inner packages, as well as in the instructions for use. In addition to the mandatory Turkish information, information can also be presented in any official language used by EU member countries.

Labelling is not required on transparent outer packages. However, for such packaging arrangements, all the information required to be on the outer package (listed above), must be included on the inner package instead.

15. What additional information may be included in labelling and packaging?

Along with the mandatory information mentioned in Question 14, some non-compulsory elements are permitted for the label, such as the firm’s logo, or the label/logo of the marketing firm. The product’s barcode can also be displayed. The pricing list for the medicine can also be put on the label. The label can also include logo or symbols of the above mentioned information that make understanding easy for the consumer.

16. What items may not be included in labelling and packaging?

Any logo that might confuse consumers, or which mimics “CE”, must not be included on the device (Article 18, Regulation on the Medical Devices). On the other hand, although it is not explicitly stated, it is understood that packaging must not include any logo, mark or symbol that would lead the consumer to use more of a medicine or use the medicine without any need. Accordingly, labels must not include anything that would mislead the consumer in terms of substances or way of usage.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

The Regulation on Promotion of Medicinal Products for Human Use regulates the marketing and advertising of human medicines. The Regulation on Sale, Advertising and Promotion of Medical Devices regulates the marketing and advertising of medical devices.

Promotion of medicinal products can only be made to physicians, dentists and pharmacists via (Article 5, Regulation on Promotion of Medicinal Products for Human Use):

• Using the promotion materials to the physicians, dentists and pharmacists,
• Organizing scientific meetings and product promotion meetings,
• Visiting physicians, dentists and pharmacists through the product promotion representatives.

Medical devices cannot be advertised to the public if they can only be operated by healthcare professionals, or by parties on the Social Security Institution’s reimbursement list. These medical devices can only be promoted to healthcare professionals and technical personnel who work for medical devices in the healthcare institutions and organizations. Promotion can be done through brochures, symposiums, meetings, or personal visits. The Regulation on Sales, Advertising and Promotion of Medical Devices outlines detailed rules on permitted promotional activities.

No monetary advantage can be gained from the advertisements of the medical devices to the physicians, dentists or medical staff; proposals relying on monetary advantages shall not be made as regards to the medical samples or advertisement activities. Advertising activities cannot include information or visuals that promote excessive use of the medicine (Article 6, Regulation on Promotion of Medicinal Products for Human Use).

Medical products cannot be marketed directly to the consumers.

Pharmacies cannot use advertisement labels or posters to promote products in their windows (Article 25/3, Regulation on Pharmacists and Pharmacies).

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Pharmacies have sole authority to sell medicine in Turkey. All medicine (prescribed or not), licensed herbal medicines, homoeopathical products (which are subject to TİTCK approval) must only be sold in pharmacies (Article 42/1, Regulation on Pharmacists and Pharmacies).

Pharmacies can also sell food supplements, medicine, chemicals and other medical products used in pharmacies and agriculture, veterinary medical products and cosmetics. The medicine sold in pharmacies cannot be sold on any other channel or online. Pharmacies cannot have their own websites to sell medicine, nor sell or deliver medicine via post. However, in 2016 Social Security Institution and Post and Telegraph Organization (“PTT”) executed a protocol regarding the delivery of the medicines via post. Turkish Employer Pharmacists Union (“TEİS”) made an objection against this protocol before the Council of State, claiming that this procedure will be explicitly against the laws and will promote unawareness among the patients. Additionally, TEİS states that the delivery of some drugs requires special transportation and storage conditions and that PTT does not have such expert and knowledge to conduct the transportation of these medicines. The Council of State decided to stay enforcement of the protocol, so currently the delivery of the medicines cannot be conducted via postal services until this case is resolved.

Medicine cannot be marketed directly or indirectly on internet, social media or any other communication form that is publicly available, such as movies, TV shows, or news.

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

Medicine cannot be marketed directly or indirectly on internet, social media or any other communication form that is publicly available, such as movies, TV shows, or news.

Accordingly, online publication regarding use of products can only be done with TİTCK’s permission and only on websites permitted by TİTCK. No advertising or informational activity can be made on websites which aren’t permitted by TİTCK. Advertisements to promote and introduce a new medicine to medical staff in magazines or newspapers which are permitted by TİTCK are exempted from this prohibition.

20. May medicines and devices be advertised or sold directly to consumers?

In case of an epidemic or vaccinations which are crucial to public health, informative activities for the public can be directly conducted via designated channels (Article 6/1, Regulation on Promotion of Medicinal Products for Human Use). In such case, advertising must be made in accordance with limits laid down by the Ministry.

Prescription medicines cannot be directly purchased by patients. Rather, these can only be sold with a valid and up-to-date prescription, issued by a physician.

Medical devices can be advertised to the public, except for devices which can only be operated by healthcare professionals or which are in the Social Security Institution’s reimbursement list (Article 15/2, Regulation on Sales, Marketing and Promotion of Medical Devices).

21. How is compliance monitored?

The Regulation on Safety of Drugs regulates medicinal product safety in Turkey. It outlines responsibilities for marketing authorization holders, healthcare providers, health institutions and organisations, as well as for the Authority itself.

The Authority reviews all data scientifically through pharmacovigilance systems. It must track the results of precautions taken within the scope of risk management plans prepared by marketing authorization holders, as well as evaluate updates in risk management plans.

The Authority can give marketing authorization holders time to rectify failures to comply with the Regulation on Safety of Drugs. Depending on the nature of the breach, the period can range between 15 days and three months. Marketing authorization will be suspended if the breach is not rectified within the period.

A medicinal product’s effectiveness and safety must be maintained following market entry. The product must also bear the appropriate technical and pharmaceutical specifications.

If the marketing authorization holder fails to comply with the related regulations, the Ministry can suspend its marketing authorization (Article 22, Licensing Regulation on Human Medicinal Products). If a medicinal product’s marketing authorization is suspended, manufacturing and import of this product must also cease (Article 22, Licensing Regulation on Human Medicinal Products). The marketing authorization holder is allowed six months to submit rebuttal documents to the Ministry regarding the suspension. If the marketing authorization holder fails to do so, the authorization will be cancelled.

Samples of advertisements must be approved in advance by the Ministry. Films prepared concerning the scientific properties of a preparation may be screened by the permit from the Ministry and at the places indicated by the Ministry.

22. What are the potential penalties for noncompliance?

As per Article 18 of Law on Pharmaceutical and Medical Preparation, an administrative penalty up to five times of the previous year’s total annual sales of non-compliant product (minimum 100,000 Turkish Lira) applies for those who:

• Promote or sell preparations contrary to the obligations set forth in the legislation,
• Sell off these products beyond their scope of certified indications,
• Encourage writing prescription in this manner.

If promotion or sales are made over the internet, the Ministry shall immediately conclude to block access to these websites. This decision will be notified to the Information and Communications Authority for implementation. Administrative penalty of between 20,000 and 300,000 Turkish Lira will be given to those who promote or sell a product using a health declaration, without the permission of the competent authority or contrary to given permission.