What Does the Regulation on the Procurement of Pharmaceuticals from Abroad Introduce?

New Developments

The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") published the Regulation on the Procurement of Pharmaceuticals from Abroad ("Regulation") in the Official Gazette dated 03.02.2023 and numbered 32093. The Regulation introduces new provisions on various issues such as the initial pharmaceutical application for the procurement of pharmaceuticals from abroad; the application for the use of pharmaceuticals from abroad; bulk procurement; requirements for pharmaceuticals procured from abroad; and the responsibility of suppliers and representatives. The provisions regarding the appointment of representatives entered into force on 03.03.2023; the provisions regarding the tracking of pharmaceuticals procured from abroad will enter into force on 03.05.2023; the provisions regarding the possession of authorization certificates by foreign pharmaceutical suppliers will enter into force on 03.08.2023; and other provisions entered into force on the date of publication. The Regulation repealed the Guidelines for the Procurement and Use of Pharmaceuticals from Abroad dated 23.10.2021 and its annexes. The Regulation is available online here (in Turkish).

What's New?

Initial Pharmaceutical Application

As per the Regulation, the initial pharmaceutical application must be made to the TİTCK by the patient's doctor along with certain documents, including the Medical Board Report, if it is required for the diagnosis and/or treatment of diseases for patients (i) for whom all treatment options with licensed pharmaceuticals have been used or (ii) who have a condition that prevents their use. For the initial pharmaceutical application, certain information and documents such as the Medical Board Report, the Request Form for Foreign Pharmaceutical Use, the Informed Patient Consent Form, scientific literature proving the efficacy and safety of the relevant active substance in the use of the relevant indication, and an epicrisis containing the values of the treatments received by the patient must be submitted.

If the initial pharmaceutical application is approved, the TİTCK will notify the foreign pharmaceutical suppliers to initiate the pharmaceutical research processes involving the relevant active substance and form, and the result of the evaluation will be notified to the doctor.

Application for Use of Pharmaceuticals from Abroad

The application for the use of pharmaceuticals from abroad can be made to the TİTCK via the Electronic Prescription System with the Request Form for Use of Pharmaceuticals from Abroad, the Informed Patient Consent Form, scientific literature proving the efficacy and safety of the relevant active substance in the use of the relevant indication, and an epicrisis containing the values of the treatments received by the patient. The TİTCK's authorization is not required for the use of the active substances whose conditions of use are specified in the List of Abroad Active Substances that can be used without Additional Approval in patients who meet these conditions.

If the use of pharmaceuticals from abroad was initiated without the authorization of the TİTCK, retrospective applications for such cases will not be evaluated except in medical emergencies.

For patients who have received a positive response in terms of efficacy and side effects after the treatment, the doctor can make an application within the last month of the authorization if they wish to continue the treatment.

In cases requiring the termination of treatment due to the progression of the disease, the death of the patient, a drug allergy or serious adverse effects, the doctor undertaking the treatment must inform the TİTCK within 5 working days at the latest, together with the reason.

Except for the conditions of use defined for the active substances included in the List of Abroad Active Substances that can be used without Additional Approval published by the TİTCK, the permission for the use of abroad active substances is individual and is given for the specific clinical situation of the patient. The authorization granted for any patient does not set a precedent for other patients with a similar diagnosis but with a different clinical course, and does not reflect the general health strategy of the TİTCK regarding the requested active substance.

The TİTCK can revoke the authorization or change the dose and duration of treatment due to the patient's progressing or changing clinical condition.

Bulk Procurement Application

Hospitals must submit the applications for the bulk procurement of pharmaceuticals for use in a medical emergency. The application shall include the medical emergency in which the use of the pharmaceutical is envisaged, and the name and anticipated quantity of the active substance to be procured.

The pharmaceuticals requested to be procured in bulk by hospitals must be of vital importance for patient health. The bulk applications made by hospitals for these pharmaceuticals will be evaluated by prioritizing the applications of public hospitals affiliated with the Ministry of Health and university hospitals. If the bulk procurement application is approved, the TİTCK will notify the foreign pharmaceutical suppliers to initiate the pharmaceutical research processes involving the relevant active substance and form, and the result of the evaluation will be notified to the hospital applying for bulk procurement.

Requirements for Pharmaceuticals Procured from Abroad

Pharmaceuticals to be procured from abroad must be manufactured within the scope of good manufacturing practices ("GMP") and their quality, efficacy and safety must be demonstrated by clinical trials conducted in compliance with good clinical practices ("GCP").

For pharmaceuticals containing active substances notified to foreign pharmaceutical suppliers, it is essential to protect patient health at a high level. Only pharmaceuticals that meet one of the following criteria can be procured in terms of marketing authorization criteria:

• They must be approved, issued with a marketing authorization and placed on the market as having a scientifically acceptable quality, efficacy and safety by the competent pharmaceutical authorities that are the founding or permanent members of the International Council for Harmonization ("ICH"), the Medicines and Healthcare products Regulatory Agency ("MHRA") or the Therapeutic Goods Administration ("TGA").
• They must have a valid certificate of conformity covering the relevant product granted after a GMP audit by the TİTCK or the competent medicines authorities that are the founding or permanent members of the ICH, or the MHRA or the TGA. These pharmaceuticals must have been placed on the market in the country of procurement or in any of the countries. For pharmaceuticals to be procured under this Regulation, the TİTCK can request all kinds of information and documents to demonstrate the safety and efficacy of the product, clinical research and/or studies to be conducted in accordance with the criteria to be determined for these pharmaceuticals, and it can conduct an evaluation with the competent authority that has applied for or granted a marketing authorization.
• If there is no pharmaceutical that complies with the above in terms of treatment options, the Foreign Pharmaceuticals Evaluation Board can grant patient-based approval for the relevant pharmaceutical for which there is a medical necessity in terms of treatment in the patient-based evaluation made by the Commission for the Evaluation of the Use of Pharmaceuticals for Personal Treatment.

The pharmaceuticals to be procured in accordance with the above practices must be issued with a marketing authorization for the same indication as the indication specified by the doctor requesting their use in Türkiye, or they must have been authorized for use for the same indication by the competent authorities of the relevant country or countries.

Responsibilities of Foreign Pharmaceutical Suppliers and Representatives

Foreign pharmaceutical suppliers must have the authorization certificate issued by TİTCK in accordance with the provisions of Law No. 984 and the Regulation on Pharmacies and Products Stored in Pharmacies. In this regard, they must operate in accordance with the Good Distribution Practices legislation. The responsible manager in foreign pharmaceutical suppliers is obliged to establish and maintain a pharmacovigilance system with the responsibilities defined in the relevant laws and the provisions of the Regulation on Pharmacies and Products Stored in Pharmacies.

Foreign pharmaceutical suppliers must keep the relevant documents and records of all batches of imported pharmaceuticals for at least 14 years, in order to provide them upon request by the TİTCK.

Foreign pharmaceutical suppliers must deliver the pharmaceuticals permitted to be procured by the TİTCK to the requesting person within 15 working days at the latest following the receipt of the prescription within the scope of good distribution practices.

Stock Keeping Obligation

Except for bulk procured pharmaceuticals and pharmaceuticals imported with permission for patient-based use, it is essential that foreign pharmaceutical suppliers keep pharmaceuticals in stock for a minimum of one (1) month and a maximum of six (6) months in order to ensure patient access to pharmaceuticals and sustainable healthcare service delivery. Accordingly, if the stock of pharmaceuticals cannot be ensured within the specified minimum period, foreign pharmaceutical suppliers must notify the TİTCK along with the justification. In addition, information on the supplier and origin, stock quantity and serial number of pharmaceuticals procured by foreign pharmaceutical suppliers before the publication date of the Regulation and pharmaceuticals to be procured within the scope of import authorization obtained before the publication date of this Regulation must have been notified to the TİTCK until 18.02.2023.

Consequence of Non-Compliance

TİTCK can impose all kinds of penalties in the relevant legislation, including import restrictions, on foreign pharmaceutical suppliers and representatives that are found to be incompliant with the provisions of the Regulation, and it can issue a ban decision from the activities within the scope of this Regulation. In this regard, the existing import permits of the foreign pharmaceutical suppliers to which a ban decision has been imposed shall be canceled.

Representative

The representative fulfills the obligations of the foreign pharmaceutical supply source on its behalf. The appointment of a representative is subject to the issuance of an authorization document and written acceptance by the foreign pharmaceutical supply source. The representative shall provide a copy of the authorization document to the TİTCK on its request. In order to procure a pharmaceutical from abroad by foreign pharmaceutical suppliers within the scope of this Regulation, the supplier must have a representative resident in Türkiye. Foreign pharmaceutical suppliers can be the representative if they meet the relevant requirements.

The representative must fulfill at least the following duties of the foreign pharmaceutical supply source in relation to the pharmaceuticals within the scope of the authorization certificate:

• The representative must verify that technical documentation defined in accordance with the guidelines published by TİTCK has been prepared by the foreign pharmaceutical supply source.
• The representative shall cooperate with the foreign pharmaceutical supplier in corrective or preventive actions to eliminate or, if this is not possible, reduce the risks arising from pharmaceuticals.

Conclusion

The Regulation reformulated the processes of procurement of pharmaceuticals from abroad and consolidated the TİTCK's instructions on the matter. Companies operating in the healthcare sector should carefully review the provisions of the Regulation and TİTCK's announcements and take the necessary actions to ensure compliance.

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