The government aims to make Turkey one of the world's top 10 economies in the field of health services by 2023. As a result, Turkey's pharma industry is expected to reach $23 billion turnover by 2023 and imported products will continue to account for approximately half of the market share.(1) The import of pharmaceuticals is expected to maintain its significant market share in the coming years.
From a legal perspective, the import of pharmaceuticals into Turkey is possible:
- by obtaining marketing authorisation from the Ministry of Health;
- by importing a product via an authorised pharmaceutical warehouse under the named patient programme; or
- for compassionate use.
Pursuant to Article 5 of the Regulation on the Registration of Medicinal Products for Human Use, no medicinal product for human use can be marketed unless it has been licensed by the Ministry of Health. Real or legal persons located in Turkey may prepare and submit the required documents to obtain market authorisation, as set out under the regulation. Within this scope, real persons must be pharmacy, medical or chemical science graduates and be authorised to practice their profession in Turkey. On the other hand, legal persons must employ one person with the abovementioned qualifications and the experience and knowledge regarding the products for which an application is submitted. Such legal persons must establish a scientific department in their organisation and appoint:
- a physician, dentist or pharmacist who will be responsible for compliance regarding promotional activities; and
- a pharmacovigilance officer who must be a physician or pharmacist.
The regulation requires that a good manufacturing practice certificate be submitted along with a marketing authorisation application. Obtaining a good manufacturing practice certificate, therefore, is a prerequisite for a marketing authorisation application. In accordance with the Ministry of Health announcement, good manufacturing practice certificates can be granted only following an on-site inspection conducted by ministry personnel. In practice, obtaining a good manufacturing practice certificate and marketing authorisation for a pharmaceutical product may take two to three years or more due to the ministry's heavy workload, unless the application received first-level priority.
At present, Pharmaceutical Inspection Cooperation Scheme membership provides little in terms of good manufacturing practice audits and required mutual recognition agreements are not signed.
If a product has received marketing authorisation in another country, but not in Turkey, or has been granted marketing authorisation in Turkey, but is unavailable for commercial reasons, it may be placed on the market via the named patient programme. The programme was developed to secure patient access to pharmaceuticals by the Social Security Institution and the Pharmacists Association. At present, the Social Security Institution is the dominant purchaser of health services governed by national social security legislation and finances almost 98% of health services in Turkey, while the Pharmacists Association is the named patient programme's dominant supplier and authorised pharmaceutical warehouse.
According to the Guidelines on the Procurement of Medicines Abroad, Medicines and Medical Devices Agency approval is not required in principle for the import of medicines included on the Foreign Pharmaceuticals List's active substance list on a prescription basis. However, the use of medicines which are not included on the active substance list requires Medicines and Medical Devices Agency pre-approval. In addition, if an active substance that is not included on the Foreign Pharmaceuticals List is prescribed, Medicines and Medical Devices Agency approval is required for the import of the relevant product. Consequently, prescriptions are a prerequisite for patient access to such pharmaceuticals, but Medicines and Medical Devices Agency approval depends on the medicine's status and whether it is included on the Foreign Pharmaceuticals List.
The compassionate use programme's requirements are set out under the Ministry of Health's Guidelines on Compassionate Use Programme. Accordingly, pharmaceuticals which are licensed in another country, but not in Turkey, can be imported where a patient's treatment with existing licensed products has failed and he or she suffers from a serious, urgent or life-threatening disease and cannot take part in clinical trials.
The compassionate use programme is used for drugs whose Phase-II trials have been concluded following an application to and approval from the General Directorate for Pharmaceuticals and Pharmacy. The programme must be undertaken and an application procedure carried out by a researcher or medical doctor. Further, the import and procurement of drugs under this programme must be free of charge and be on a patient-by-patient basis.
In line with the complicated regulatory landscape and documentation requirements, compassionate use programme approval is exceptional.
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For further information on this topic please contact E Sevi Firat or Erdinc Kirmizioglu at Firat Izgi Attorney Partnership by telephone (+90 212 235 25 25) or email (firstname.lastname@example.org or email@example.com). The Firat Izgi Attorney Partnership website can be accessed at www.firatizgi.com.