Esin / Healthcare & Life Sciences - July 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Regulation on the Marketing Authorization of Homeopathic Medicinal Products and Announcement on the Extension of the Approval Periods for the Use of Off-Label and Foreign Pharmaceuticals.

Regulation on the Marketing Authorization of Homeopathic Medicinal Products

On 8 July 2023, the TİTCK published the Regulation on the Marketing Authorization of Homeopathic Medicinal Products. The Regulation repealed the Regulation on Marketing Authorization of Homeopathic Medicinal Products published in the Official Gazette dated 24 December 2021 and numbered 31699. In addition, the Regulation was prepared within the framework of harmonization with European Union legislation, considering Directive 2001/83/EC of the European Parliament and the Council dated 6 November 2001 on pharmaceuticals. The main developments introduced by the Regulation are as follows:

• Applications for homeopathic medicinal products that are derived from more than one homeopathic stock and have an indication are referred to as full applications. In full applications, the applicant must also submit to the TİTCK the results of preclinical tests including toxicological and pharmacological tests and the results of clinical trials.
• For clinical trials conducted in Türkiye, the applicant must submit to the TİTCK a document indicating that the clinical trials have been granted research authorization. For clinical trials conducted abroad, the applicant must submit a declaration to the TİTCK that it complies with the scientific and ethical requirements. In addition, as of 1 January 2025, the applicant must submit to the TİTCK a certificate of research authorization for clinical trials issued by the TİTCK, the Australian Medicines Authority, the UK Medicines Authority, the founding or permanent member competent authorities of the International Harmonization Committee, and for clinical trials authorized by health authorities other than these, the good clinical practice audit report issued by these authorities must also be submitted to the TİTCK.
• In applications for jointly marketed homeopathic medicinal products, a letter of commitment must be submitted that the homeopathic medicinal products subject to joint marketing are exactly the same, that all variation applications will be made in accordance with the legislation and that they will be produced in the same production sites.
• For marketing authorization applications, the applicant must submit an assessment of the potential environmental risk posed by the homeopathic medicinal product.
• Applications for homeopathic medicinal products that fulfill the following conditions are referred to as abridged applications:
• Oral or external use of a homeopathic medicinal product,
• Derived from a single homeopathic stock,
• No indication in all file information of the homeopathic medicinal product,
• Sufficiently diluted to guarantee the safety of the homeopathic medicinal product, in particular that the finished product, which does not require a doctor’s prescription, contains less than one part in 10,000 of the base tincture or less than 1% of the lowest dose of the active substances used in the treatment according to the literature.
• The applicant must submit expert reports signed by relevant experts for each of the chemical, pharmacological, biological, toxicological and clinical sections of the registration file. In abridged applications, it is not necessary to submit the requested information on the pharmacological and clinical sections.
• The marketing authorization period for marketing authorization applications for jointly marketed products is 90 days.
• In granting a marketing authorization for a homeopathic product, the TİTCK will consider the proven efficacy under the prescribed conditions of use.
• If, as a result of the evaluation of full applications, it is determined that the therapeutic effect of the product is insufficient or the therapeutic effect cannot be sufficiently proven, the marketing authorization application will be rejected on the merits.
• The marketing authorization can be renewed by the TİTCK 5 years after the date of grant, considering the balance of risk and benefit. For marketing authorizations that have been renewed once, the marketing authorization will be valid indefinitely unless the TİTCK decides to conduct an additional 5-year renewal assessment for pharmacovigilance-related reasons.
• In cases where the marketing authorization holder cannot place the product on the market, the marketing authorization holder must inform the TİTCK 30 days prior to the occurrence of the situation that the product cannot be placed on the market.

The Regulation is available here (in Turkish).

Announcement on the Extension of the Approval Periods for the Use of Off-Label and Foreign Pharmaceuticals

On 10 July 2023, the TİTCK published an Announcement on the Extension of the Approval Periods for the Use of Off-Label and Foreign Pharmaceuticals. In this regard, off-label and foreign pharmaceutical use approvals, which expired or will expire as of 1 December 2022, have been extended until 13 December 2023. However, as per Article 4.1.4 of the Social Security Institution Health Implementation Communiqué, approvals for use shall not exceed 1 year in total, including extensions.

The Announcement is available here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TİTCK’s announcements and take necessary actions to ensure compliance.

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