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The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) recently published the Guideline on the Inspection of Good Distribution Practices, the Guideline on Triggers of Routine and/or “for a Specific Reason” Inspections, the Guideline on Triggers of Inspections on Bioavailability/Bioequivalence Studies and the inspection results of the final quarter of 2021 on cosmetics and type 1 and type 19 biocidal products.
Please click on the relevant link below for our specific notes regarding recent developments:
What does the Guideline on the Inspection of Good Distribution Practices bring?
What do the Guideline on Triggers for Routine and/or for “Specific Reason” Inspections and the Guideline on Triggers for Inspections of Bioavailability/Bioequivalence Studies cover?
Results of the Market Surveillance And Inspection Of Cosmetic and Biocidal Products Have Been Announced
What does the Guideline on the Inspection of Good Distribution Practices bring?
New Development
On 15 February 2022, the TİTCK introduced certain regulations to ensure that inspections regarding the storage and distribution of medicinal products for human use are conducted in accordance with the applicable laws, nationally and internationally accepted standards and good distribution practices.
The Guideline is available here (in Turkish).
What’s New?
The main regulations within the scope of the Guideline are as follows:
- Companies that wish to operate as a pharmaceutical warehouse or change their address should apply to the Provincial Health Directorate (“Directorate“). A license for documentation, annotation or change of address can be issued upon the on-site inspection that will be carried out within the scope of the Good Distribution Practices Inspection Unit’s planning regarding the opening and transfer operations of pharmaceutical warehouses.
- An application must be submitted to the Directorate of the province where the pharmaceutical warehouse operates prior to any renovations to be made in the warehouses. An on-site inspection can be carried out by inspectors based on the Directorate’s decision.
- On a routine basis or upon complaint, the TİTCK or Directorates can inspect the buildings, devices, records, purchasing, storage and shipping processes, quality assurance systems, the personnel of pharmaceutical warehouses and whether the responsible manager is present.
- Pharmaceutical warehouses planning to cease their activities should apply to the Directorate of the province in which they operate for the closing procedures. If it determines that there are no medicinal products for human use in the warehouse, the license of the relevant warehouse can be revoked.
- Administrative sanctions set forth under the Law No. 984 on Pharmaceutical Businesses and Shops Where Toxic and Active Chemicals Used in Art and Agricultural Works are Sold and the Regulation on Pharmaceutical Warehouses and Products in Pharmaceutical Warehouses can be applied for violations such as inappropriate storage of products, transfer of the warehouse without permission and incompatibility between the pharmaceutical tracking system and the warehouse’s records.
- Warehouses where medicinal products for human use and similar products that require special precautions are stored should have the required equipment, store products under appropriate conditions and immediately record products in a report with the customs officer or authorized customs consultant.
- The conditions of the areas where drugs are stored in hospitals and whether product transfers comply with the Drug Safety Guidelines are subject to inspections, the result of which is reported to the TİTCK. Also, pharmaceutical warehouses in hospitals affiliated with the Ministry of Health are evaluated at least once a year within the scope of the Directive on the On-Site Evaluation of the Efficiency of Health Facilities Affiliated with the Ministry of Health.
What do the Guideline on Triggers for Routine and/or for “Specific Reason” Inspections and the Guideline on Triggers for Inspections of Bioavailability/Bioequivalence Studies cover?
New Development
On 25 February 2022, the TİTCK published the Guideline on Triggers for Routine and/or for “Specific Reason” Inspections, and the Guideline on Triggers for Inspections of Bioavailability/Bioequivalence Studies.
The Guidelines are available here (in Turkish).
What Will Change?
• Guideline on Triggers for Routine and/or for “Specific Reason” Inspections
In principle, a detailed examination of all clinical investigations in a license application process is not always required. However, an inspection should be requested if triggers have been identified and the alternative method fails to provide the necessary assurance or unresolved issues remain after the evaluation process.
The guideline lays out the issues to be considered in selecting new registration applications of medicinal products for human use and clinical trials for the routine and “for a specific reason” inspection program.
In selecting files, research and centers that will be subject to routine inspections, factors such as the quality of the file, the type of product, information on the applicant/supporter or contracted research institution, the scope of clinical data, the size of the study, the country where the study was conducted and the target population should be taken into account. On the other hand, audits “for a specific reason” are those requested by the evaluators due to suspicion of noncompliance with good clinical practice. It is possible to report such suspicions to the vice president of Inspection Services or to request information from the applicant on the suspicious matters. Whether an audit is required or not is decided by the vice president of Inspection Services.
• Guideline on Triggers for Inspections of Bioavailability/Bioequivalence Studies
The guideline identifies some of the triggers that can be taken into account prior to submitting an inspection request for bioavailability/bioequivalence studies provided in the marketing authorization application of generic products.
In this context, the decision should be made in light of factors such as whether the study or the center was inspected by the TİTCK before, whether there is missing information or observations that would raise doubts on the validity and quality of the study data.
Results of the Market Surveillance And Inspection Of Cosmetic and Biocidal Products Have Been Announced
New Development
The TİTCK recently announced the results of its market surveillance and inspection conducted between October and December 2021 on cosmetics products and the type 1 biocidal products that are in direct contact with the human body, such as hand disinfectants, antibacterial liquid soaps and type 19 biocidal products, such as fly repellents.
Of the 550 cosmetic products inspected by the TİTCK’s Cosmetics Supervision Department, 392 were noncompliant and three were unsafe. A total fine of TRY 310,000 (approximately USD 21,925) was levied against the responsible companies. 853 fake, illegal and/or imitated perfumes whose manufacturer was unknown were determined to be unsafe and destroyed.
Of the 48 type 1 and type 19 biocidal products inspected by the TİTCK’s Cosmetics Supervision Department, nine were noncompliant and 37 were unlicensed. A total fine of TRY 1,480,000 (approximately USD 104,674) was levied against the responsible companies.
What Do The Results Say?
The cosmetic products’ safety results reveal that there is a decrease in the number of noncompliant products despite the slight increase in the number of inspected products. The total amount of administrative fines has significantly decreased compared to the results of third quarter of 2021.
The type 1 and type 19 biocidal products’ safety results are the same as Q3 2021.
Cosmetics products’ Q4 2021 results are available here (in Turkish).
Type 1 and type 19 biocidal products’ Q4 2021 results are available here (in Turkish).
Conclusion
The TİTCK continues to introduce guidelines for inspections and demonstrate its commitment to periodical market surveillance and inspections in the healthcare sector. All products in circulation must fully comply with the applicable Turkish laws and regulations, and companies should carefully review the relevant laws and take the necessary actions to ensure compliance.
