(i) Regulation on the Duties, Authorities and Responsibilities of the National Control Laboratory of the Turkish Pharmaceuticals and Medical Devices Authority
(ii) Guideline on the Pharmacovigilance System
(iii) Decree on the Pricing of Medicinal Products for Human Use
(iv) Regulation on the Marketing Authorization of Medicinal Products for Human Use
(v) Annulment of the Decision on the Extension of the Approval Periods for the Use of Off-Indication/International Medicinal Products
(vi) Implementing Regulations (EU) No. 2022/2346 and (EU) No. 2022/2347
(vii) Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment
(viii) Regulation on Private Hospitals
(ix) Guideline on the Implementation of the Regulation on Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices
(x) Guideline on Applications for GMP Inspection of Overseas Manufacturing Facilities
(xi) Communiqu on Pricing of Medicinal Products for Human Use
(xii) Announcement on the Medical Device Clinical Trials
(xiii) Conclusion
Healthcare & Life Sciences Newsletter 3
Healthcare & Life Sciences Newsletter 4
Healthcare & Life Sciences Newsletter
The Turkish Pharmaceuticals and Medical Devices Authority ("TTCK") recently published the Regulation on the Duties, Authorities and Responsibilities of the National Control Laboratory of the Turkish Pharmaceuticals and Medical Devices Authority, Guideline on the Pharmacovigilance System, an announcement regarding European Union (EU) Implementing Regulations No. 2022/2346 and No. 2022/2347 and an announcement on Medical Device Clinical Trials. Moreover, the TTCK has amended (i) the Decree on the Pricing of Medicinal Products for Human Use (ii) Regulation on the Marketing Authorization of Medicinal Products for Human Use; (iii) Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment; (iv) Regulation on Private Hospitals; (v) Guideline on the Implementation of the Regulation on Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices; (vi) Guideline on Applications for Good Manufacturing Practices (GMP) Inspection of Overseas Production Facilities; and (vii) Communiqu on Pricing of Medicinal Products for Human Use. Lastly, the TTCK announced the annulment of the Decision on the Extension of the Approval Periods for the Use of Off-Indication/ International Medicinal Products.
Regulation on the Duties, Authorities and Responsibilities of the National Control Laboratory of the Turkish Pharmaceuticals and Medical Devices Authority
The Regulation on the Duties, Authorities and Responsibilities of the National Control Laboratory of the Turkish Pharmaceuticals and Medical Devices Authority was published by the TTCK on 30 November 2022 and entered into force through its publication. In this regard, the Regulation sets out the duties, authorities and responsibilities and working procedures and principles of the National Control Laboratory, where the analysis activities of the substances and products falling under the duties and responsibilities of the TTCK and the serial release activities regarding the vaccines and immune serums filled and/or produced in Trkiye are carried out.
According to the said Regulation, it should be ensured that the laboratories have appropriate equipment related to the relevant fields of activity, necessary measures should be taken to ensure that the equipment used and the results of the analysis are not affected by environmental conditions. In addition, the environment should be protected from adverse conditions such as dust, humidity, steam, vibration, electromagnetic factors and harmful creatures. In addition, appropriate measures such as an emergency body and eye shower should be taken in easily accessible suitable places to be used in case of danger in the laboratory.
The Regulation is available here (in Turkish).
Guideline on the Pharmacovigilance System
The TTCK published the Guideline on Pharmacovigilance System on 30 November 2022. The Guideline is prepared to explain the structure of the pharmacovigilance system established within the TTCK. In this regard, the Guideline provides guidance on many issues such as the pharmacovigilance system of the TTCK, data and records management, the duties of the TTCK related to pharmacovigilance and the distribution of duties by units, and the duties of the Turkish Pharmacovigilance Center (TFAM).
The Guideline provides information on the mission and organizational structure of the TTCK and discusses in detail the core values and functioning of the pharmacovigilance system.
The pharmacovigilance-related duties of the TTCK are carried out by the Department of Pharmacovigilance and Controlled Substances in line with the Regulation on the Safety of Pharmaceuticals and the current Circular on Unintended Effects After Vaccination (ASIE) of the General Directorate of Public Health and Circular No. 2022/2 dated 28 September 2022. The relevant Department consists of two sub-departments, namely the TFAM, where pharmacovigilance activities are carried out, and Pharmacovigilance Risk Management Unit. While the TFAM carries out studies on adverse events, the Pharmacovigilance Risk Management Unit is more focused on the drug safety of foreign pharmaceutical authorities. According to the Guideline, the duties and responsibilities of both departments are set out in detail.
The Guideline is available here (in Turkish).
Decree on the Pricing of Medicinal Products for Human Use
On 14 December 2022, the Presidency published the Decree Amending the Decree on the Pricing of Medicinal Products for Human Use. The main amendments introduced by the Decree are as follows:
The effective date of the actual source price or sales price changes made in accordance with the Communiqu on the Pricing of Medicinal Products for Human Use was set as the publication date of the Decree for 2022, i.e. 14 December 2022.
The value of one Euro in TRY to be used in the pricing of medicinal products for human use was increased by 36.77%, effective from 15 December 2022. The calculated increase will continue to be applied for the next year and a new Euro value will not be announced during 2023.
The thresholds in the Decree have been updated in line with the change in the value of the Euro. They have been increased to TRY 37.10 for price-protected products and TRY 19.39 for other products. This update is effective as of 15 December 2022.
The Decree is available here (in Turkish).
Healthcare & Life Sciences Newsletter 5
Healthcare & Life Sciences Newsletter 6
Regulation on the Marketing Authorization of Medicinal Products for Human Use
On 14 December 2022, the TTCK published the Regulation Amending the Regulation on the Marketing Authorization of Medicinal Products for Human Use, which became effective retrospectively, as of 11 December 2022. The main amendments introduced by the Regulation are as follows:
If any of the nonconformities listed in the Regulation occur, the TTCK should make an assessment including the safety of the nonconformity before suspending the marketing authorization. The marketing authorization may be suspended according to the results of this assessment.
The deadline for the completion of the marketing authorization process for (i) radionuclide generators, kits, radionuclide precursor radiopharmaceuticals, industrially prepared radiopharmaceuticals placed on the market with a registration certificate and for which a marketing authorization application has been submitted; and for (ii) blood products and immunological medicinal products for human use placed on the market with an import permit and for which a marketing authorization application has been submitted, has been postponed to 31 December 2023.
The Regulation is available here (in Turkish).
Annulment of the Decision on the Extension of the Approval Periods for the Use of Off-Indication/ International Medicinal Products
The TTCK previously extended the expiry date of all off-label drug use approvals granted by the TTCK for pharmaceuticals holding marketing authorization and pharmaceuticals without marketing authorization imported from abroad by specifying the relevant active substance on a patient basis, or approvals for the use of pharmaceuticals abroad, which expired as of 1 January 2020. On 15 December 2022, the TTCK announced that it had annulled this decision, effective as of 31 December 2022. In this regard, it is necessary to apply to the TTCK to continue using the pharmaceuticals after 31 December 2022.
The Announcement is available here (in Turkish).
Implementing Regulations (EU) No. 2022/2346 and (EU) No. 2022/2347
On 16 December 2022, the TTCK published an announcement regarding the EU Commission's Implementing Regulations (EU) No. 2022/2346 and (EU) No. 2022/2347 on product groups listed in Annex XVI of the EU Medical Device Regulation (e.g. contact lenses, equipment intended for use to reduce adipose tissue such as liposuction, etc.).
Implementing Regulation No. 2022/2346 sets out common specifications addressing the implementation of risk management as set out in the general safety and performance requirements for non-medical product groups listed in Annex XVI of the (EU) Medical Device Regulation. The Implementing Regulation entered into force on 22 December 2022 and will be applicable in all EU Member States and Trkiye as of the effective date of Article 2/3 and the remaining provisions as of 23 June 2023.
In addition, Implementing Regulation No. 2022/2347 reclassifies certain product groups listed in Annex XVI of the (EU) Medical Device Regulation to ensure a conformity assessment consistent with their inherent risks prior to placing on the market of certain groups of active non-medical products. This Implementing Regulation entered into force on 22 December 2022.
In this regard, manufacturers wishing to place products listed in Annex XVI of the (EU) Medical Device Regulation on the market are required to fulfill the requirements of the Commission's Implementing Regulations No. 2022/2347 and No. 2022/2346, complete the conformity assessment process, which involves a notified body that is competent in the relevant field, and obtain a CE certificate for their products.
The Announcement is available here (in Turkish).
Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment
On 17 December 2022 and 7 January 2023, the Ministry of Health published the Regulations Amending the Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment. The main amendments introduced by the Regulation are as follows:
If it is determined that a violation of patient rights has been committed, the activities of the relevant unit will be temporarily suspended by the Governorship upon the decision of the Ministry of Health until appropriate conditions are provided, without disrupting the diagnosis and treatment process of patients outside the unit in question. Administrative and legal action will be taken against the related persons in accordance with the legislation. However, if the unit in question is of vital importance in patient diagnosis and treatment, such as
emergency, medical laboratory and imaging, it will be ensured that the unit operates under the supervision of a commission to be determined by the Provincial or District Health Directorate.
If a deficiency is detected in any unit or part of the health institution that will adversely affect the treatment of patients, the activities of the relevant unit will be suspended by the Governorship upon the decision of the Ministry of Health until the deficiency is eliminated, and if there are situations that are deemed to adversely affect the health of society or the health service recipients, the activities of the relevant unit will be suspended by the Governorship until this situation is eliminated.
Doctors who have a clinic may perform the treatment of patients who apply to their clinic in licensed health institutions by making an annual contract. Health institutions may enter into contracts with these doctors, provided that the number of the contracted doctors does not exceed onethird of the total number of staff in the relevant specialty.
Doctors who have a clinic prior to 7 January 2023 will be exempt from the abovementioned limitations concerning the staff number in the health institutions with which they will enter into a contract.
The Regulation dated 17 December 2022 is available here (in Turkish);
the Regulation dated 7 January 2023 is available here (in Turkish).
Healthcare & Life Sciences Newsletter 7
Healthcare & Life Sciences Newsletter 8
Regulation on Private Hospitals
On 17 December 2022 and 7 January 2023, the Ministry of Health published the Regulation Amending the Regulation on Private Hospitals. In this regard, a number of amendments were made in line with the amendments introduced by the Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment. The main amendments introduced by the Regulation are as follows:
If a deficiency is detected in any unit or part of the hospital that will adversely affect the treatment of patients, the activities of the relevant unit or the entire private hospital will be suspended by the Governorship until the deficiency is eliminated, and if situations that are deemed to adversely affect the health of society or the health service recipients arise, the activities of the relevant unit or the entire private hospital will be suspended by the Governorship until this situation is resolved.
If it is determined that a violation of patient rights has been committed, the activities of the relevant unit will be temporarily suspended by the Governorship upon the decision of the Ministry of Health until appropriate conditions are provided, without disrupting the diagnosis and treatment process of patients outside the unit in question. Administrative and legal action will be taken against the related persons in accordance with the legislation. However, if the unit in question is of vital importance in patient diagnosis and treatment, such as emergency, medical laboratory and imaging, it will be ensured that the unit operates under the supervision of a commission to be determined by the Provincial or District Health Directorate.
Doctors who have a clinic may perform the treatment of patients who apply to their clinic in licensed private hospitals by making an annual contract. Private hospitals may enter into contracts with these doctors, provided that the number of the contracted doctors does not exceed one third of the total number of staff in the relevant specialty.
Doctors who have a clinic prior to 7 January 2023 will be exempt from the abovementioned limitations concerning the staff number in the hospitals with which they will enter into a contract.
The Regulation dated 17 December 2022 is available here (in Turkish);
the Regulation dated 7 January 2023 is available here (in Turkish).
Healthcare & Life Sciences Newsletter 9
Guideline on the Implementation of the Regulation on Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices
On 22 December 2022, the TTCK updated the Guideline on the Implementation of the Regulation on Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices. In this regard, amendments have been introduced to allow applications to the TTCK to be made electronically. The main amendments introduced by the Guideline are as follows:
The following works and procedures are described: (i) medical physicist quality control work certificate and medical physicist quality conformity letter applications to be made electronically via e-Government Gateway, (ii) quality control and quality conformity tests to be performed on diagnostic radiology, nuclear medicine and radiotherapy group medical devices, and (iii) quality conformity body applications to be submitted electronically to the TTCK.
The content of the report to be issued after quality control and quality conformity tests has been added.
The Guideline is available here (in Turkish).
Guideline on Applications for GMP Inspection of Overseas Manufacturing Facilities
On 27 December 2022, the TTCK updated the Guideline on Applications for GMP Inspections of Overseas Production Facilities as part of its efforts to become one of the regulatory authorities listed by the World Health Organization. The main amendments introduced by the Guideline are as follows:
As the impact of the pandemic decreases, the TTCK will plan on-site GMP inspections at overseas production facilities based on risk-based assessments.
Within the framework of the provisions of the Guideline, the validity periods of GMP certificates for (i) products for which a risk-based inspection (renewal) application has been made before the expiry of the GMP certificate validity period and an on-site inspection decision has been made as a result of the evaluation, and (ii) products that do not have the right to apply for renewal for the third time in accordance with the Guideline and products for which GMP certificates were previously issued by the TTCK through an inspection on file (exemption) application made with reference to these products have been extended until 1 June 2024.
If there is a change in the scope of the GMP certificate of the products whose certificate periods have been extended, the importer companies must apply in accordance with the Guideline.
Existing GMP certificates that have not been evaluated by the TTCK and for which there is no on-site inspection decision have not been extended. In this regard, for products with GMP certificates, except for products whose validity period has not been extended by the TTCK and products for which GMP certificates have been issued in accordance with the announcement titled "Additional Measures to be Implemented During the Pandemic Process Regarding GMP Inspections and Certification Processes Overseas", risk-based and file-based inspection applications should be made in accordance with the Guideline before the expiration of the certificate validity period.
The existing GMP certificate validity periods of the products produced in the facilities where on-site inspections will be carried out will be evaluated according to the results of the inspection.
The Guideline is available here (in Turkish) and the Announcement is available here (in Turkish).
Communiqu on Pricing of Medicinal Products for Human Use
On 31 December 2022, the TTCK published the Communiqu Amending the Communiqu on the Pricing of Medicinal Products for Human Use. The main amendments introduced by the Communiqu are as follows:
For products that are priced according to the cost card, the price up to 15% more than the sum of the costs specified on the card will be determined as the sale price to the warehouse.
For imported allergy products for which the actual source price cannot be determined, a price can be given through a document issued and approved by the applicant and a certified public accountant, valid for one year, in which the costs are presented in Turkish Lira. Concerning allergy products manufactured in Trkiye for which the actual source price cannot be determined, a price can be given according to the cost card.
For traditional herbal medicinal products, medicinal teas, homeopathic medicinal products and medicinal products used in aromatherapy, prices can be given according to the declaration of the applicants.
In terms of increases calculated with the cost card, no increase can be made more than 50% of the current sales price to the warehouse keeper.
Concerning imported non-refundable products, an application for price change can be made by submitting their own real source prices during the real source price change period. If imported generic non-refundable products do not have their own price, the real source price of the non-refundable reference product will be determined as the real source price.
The Communiqu is available here (in Turkish).
Announcement on the Medical Device Clinical Trials
On 11 January 2023, the TTCK announced that it has updated the medical device clinical trial application forms. In this regard, the new form must be used for first applications to be made as of 1 January 2023.
The Announcement is available here (in Turkish).
Conclusion
The TTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TTCK's announcements and take necessary actions to ensure compliance.
Healthcare & Life Sciences Newsletter 10
Healthcare & Life Sciences Newsletter
(i) Trkiye la ve Tibb Cihaz Kurumu Ulusal Kontrol Laboratuvarinin Grev, Yetki ve Sorumluluklari ile alima Usul ve Esaslari Hakkinda Ynetmelik
(ii) Farmakovijilans Sistemi Kilavuzu
(iii) Beeri Tibbi rnlerin Fiyatlandirilmasina Dair Karar
(iv) Beeri Tibbi rnler Ruhsatlandirma Ynetmelii
(v) Endikasyon Dii/Yurt Dii la Kullanimina likin Onay Srelerinin Uzatilmasi Hakkinda Kararinin ptali
(vi) (AB) 2022/2346 Sayili ve (AB) 2022/2347 Sayili Uygulama Tzkleri
(vii) Ayakta Tehis ve Tedavi Yapilan zel Salik Kurululari Hakkinda Ynetmelik
(viii) zel Hastaneler Ynetmelii
(ix) Diagnostik Radyoloji, Nkleer Tip ve Radyoterapi Grubu Tibbi Cihazlarin Kalite Uygunluk ve Kalite Kontrol Testleri Hakkinda Ynetmelik Hkmlerinin Uygulanmasina likin Kilavuz
(x) Yurt Dii retim Tesislerinin GMP Denetimleri in Yapilacak Mracaatlara Dair Kilavuz
(xi) Beeri Tibbi rnlerin Fiyatlandirilmasi Hakkinda Tebli
(xii) Tibbi Cihaz Klinik Aratirmalari Hakkinda Duyuru
(xiii) Sonu
Healthcare & Life Sciences Newsletter 11
Healthcare & Life Sciences Newsletter 12
Trkiye la ve Tibbi Cihaz Kurumu ("Kurum") getiimiz haftalarda, Trkiye la ve Tibb Cihaz Kurumu Ulusal Kontrol Laboratuvarinin Grev, Yetki ve Sorumluluklari ile alima Usul ve Esaslari Hakkinda Ynetmelik, Farmakovijilans Sistemi Kilavuzu, (AB) 2022/2346 Sayili ve (AB) 2022/2347 Sayili Uygulama Tzkleri hakkinda duyuru ve Tibbi Cihaz Klinik Aratirmalari Hakkinda duyuru yayimladi. Kurum ayrica (i) Beeri Tibbi rnlerin Fiyatlandirilmasina Dair Karar, (ii) Beeri Tibbi rnler Ruhsatlandirma Ynetmelii, (iii) Ayakta Tehis ve Tedavi Yapilan zel Salik Kurululari Hakkinda Ynetmelik, (iv) zel Hastaneler Ynetmelii, (v) Diagnostik Radyoloji, Nkleer Tip ve Radyoterapi Grubu Tibbi Cihazlarin Kalite Uygunluk ve Kalite Kontrol Testleri Hakkinda Ynetmelik Hkmlerinin Uygulanmasina likin Kilavuz, (vi) Yurt Dii retim Tesislerinin GMP Denetimleri in Yapilacak Mracaatlara Dair Kilavuz ve (vii) Beeri Tibbi rnlerin Fiyatlandirilmasi Hakkinda Tebli'de deiiklik yapti. Son olarak Kurum Endikasyon Dii/Yurt Dii la Kullanimina likin Onay Srelerinin Uzatilmasi Hakkinda Kararinin iptaline karar verdi.
Trkiye la ve Tibb Cihaz Kurumu Ulusal Kontrol Laboratuvarinin Grev, Yetki ve Sorumluluklari ile alima Usul ve Esaslari Hakkinda Ynetmelik
30 Kasim 2022 tarihinde Trkiye la ve Tibb Cihaz Kurumu Ulusal Kontrol Laboratuvarinin Grev, Yetki ve Sorumluluklari ile alima Usul ve Esaslari Hakkinda Ynetmelik Kurum tarafindan yayimlanarak yrrle girmitir. Bu kapsamda TTCK'nin grev ve sorumluluk alanina giren madde ve rnlerin analiz faaliyetleri ile lkemizde dolumu ve/veya retimi yapilan ailar ve immun serumlara ilikin seri serbest birakma faaliyetlerinin yrtld Ulusal Kontrol Laboratuvarinin grev, yetki ve sorumluluklari ile alima usul ve esaslarini dzenlenmektedir.
Ynetmelik kapsaminda Laboratuvarlarin uygun faaliyet alanlari ile ilgili uygun donanima sahip olmasi, kullanilan gerelerin ve analiz sonularinin evre artlarindan etkilenmemesi iin gerekli tedbirler alinmali, ortamin toz, nem, buhar, titreim, elektromanyetik etkenler ve zararli canlilar gibi olumsuz artlardan korunmasi salanmalidir. Ayrica laboratuvarda tehlike aninda kullanilmak zere kolayca ulailabilir uygun yerlerde acil boy ve gz duu gibi uygun tedbirler alinmalidir.
Ynetmelik'e buradan ulaabilirsiniz.
Farmakovijilans Sistemi Kilavuzu
Kurum, 30 Kasim 2022 tarihinde Farmakovijilans Sistemi Kilavuzu'nu yayimlamitir. Kilavuz, Kurum bnyesinde kurulmu olan farmakovijilans sisteminin yapisini aiklamak zere hazirlanmitir. Bu dorultuda Kilavuz Kurum'un farmakovijilans sistemi, veri ve kayit ynetimi, Kurum'un farmakovijilans ile ilgili grevleri ve grevlerin birimlere gre dailimi, Trkiye Farmakovijilans Merkezi'nin (TFAM) grevleri gibi pek ok konuda yol gstermektedir.
Kilavuz kapsaminda Kurum'un misyonu ve organizasyonel yapisina ilikin bilgi verilmekte, farmakovijilans sisteminin temel deerleri ve ileyi sistemi detaylica ele alinmaktadir.
Kurum'un farmakovijilans ile ilgili grevleri Farmakovijilans ve Kontrole Tbi Maddeler Dairesi tarafindan "lalarin Gvenlilii Hakkinda Ynetmelik" ve Halk Salii Genel Mdrl'nn gncel "Ai Sonrasi stenmeyen Etkiler (ASE) Genelgesi" ve 28.09.2022 tarih ve 2022/2 sayili genelge dorultusunda yrtlmektedir. lgili Daire'nin bnyesinde farmakovijilans faaliyetlerinin yrtld TFAM ve Farmakovijilans Risk Ynetimi Birimi olmak zere iki blm bulunmaktadir. TFAM advers olaylara ynelik alimalar yrtrken, Farmakovijilans Risk Ynetimi Birimi daha ziyade Yurt diindaki ila otoritelerinin ila gvenliine ynelik faaliyet gstermektedir. Kilavuz uyarinca her iki birimin grev tanimlari detaylica ele alinmitir.
Kilavuz'a buradan ulaabilirsiniz.
Beeri Tibbi rnlerin Fiyatlandirilmasina Dair Karar
Cumhurbakanlii 14 Aralik 2022 tarihinde Beeri Tibbi rnlerin Fiyatlandirilmasina Dair Kararda Deiiklik Yapilmasi Hakkinda Karar'i yayimlamitir. Bu kapsamda getirilen balica dzenlemeler aaidaki gibidir:
Beeri Tibbi rnlerin Fiyatlandirilmasi Hakkinda Tebli kapsaminda yapilan gerek kaynak fiyat veya depocuya sati fiyati deiikliklerinin geerlilik tarihi 2022 yili iin Karar'in yayim tarihi, yani 14 Aralik 2022 olarak belirlenmitir.
Beeri tibbi rnlerin fiyatlandirilmasinda kullanilacak bir Avronun TL cinsinden deeri 15 Aralik 2022 tarihinden itibaren geerli olmak zere %36,77 artirilmitir. Hesaplanan arti gelecek yil iin de uygulanmaya devam edecek olup 2023 yili iin yeni bir Avro deeri ilan edilmeyecektir.
Karar'da yer alan barem deerleri Avro deerinde yapilan deiiklik oraninda gncellenmitir. Fiyat korumali rnlerde 37,10 TL ve dier rnlerde 19,39 TL'ye ikarilmitir. Bu gncelleme 15 Aralik 2022 tarihinden itibaren geerlidir.
Karar'a buradan ulaabilirsiniz.
Healthcare & Life Sciences Newsletter 13
Healthcare & Life Sciences Newsletter 14
Beeri Tibbi rnler Ruhsatlandirma Ynetmelii
Kurum, 14 Aralik 2022 tarihinde Beeri Tibbi rnler Ruhsatlandirma Ynetmeliinde Deiiklik Yapilmasina Dair Ynetmelik'i 11 Aralik 2022 tarihinden itibaren geerli olmak zere yayimlamitir. Bu kapsamda getirilen balica dzenlemeler aaidaki gibidir:
Ynetmelik'te sayilmi olan uygunsuzluk hallerinden birinin gereklemesi halinde ruhsatin askiya alinmasindan nce Kurum tarafindan uygunsuzlua ilikin gvenlilii de ieren bir deerlendirme yapilmalidir. Bu deerlendirme neticesine gre ruhsat askiya alinabilir.
Tescil belgesi ile piyasaya arz edilen ve ruhsat bavurusunda bulunulan radyonklid jeneratrler, kitler, radyonklid prekrsr radyofarmastikler, endstriyel olarak hazirlanmi radyofarmastikler ve ithalat izni ile piyasaya arz edilen ve ruhsat bavurusunda bulunulan kan rn ve immnolojik beeri tibbi rnlerin ruhsatlandirma srecinin tamamlanmasi iin getirilen son tarih 31 Aralik 2023 tarihine ertelenmitir.
Ynetmelik'e buradan ulaabilirsiniz.
Endikasyon Dii/Yurt Dii la Kullanimina likin Onay Srelerinin Uzatilmasi Hakkinda Kararinin ptali
Kurum tarafindan ruhsatli mstahzarlar ile yurt diindan ithal edilen ruhsatsiz mstahzarlar iin hasta bazinda ilgili etkin madde belirtilerek verilen endikasyon dii ila kullanim onaylari veya yurt dii ila kullanim onaylarindan 1 Ocak 2020 tarihinden itibaren sresi biten tm onaylarin biti tarihi uzatilmiti. 15 Aralik 2022 tarihinde Kurum, 31 Aralik 2022 tarihinden itibaren geerli olmak zere bu kararini iptal ettiini duyurmutur. Bu kapsamda 31 Aralik 2022 tarihinden sonraki ila kullanimlarina devam edilebilmesi iin Kurum'a bavuru yapilmasi gerekmektedir.
Duyuruya buradan ulaabilirsiniz.
(AB) 2022/2346 Sayili ve (AB) 2022/2347 Sayili Uygulama Tzkleri
Kurum, 16 Aralik 2022 tarihinde AB Komisyonu Tarafindan AB Tibbi Cihaz Ynetmeliinin EK XVI'sinda listelenen rn gruplarina (rnein kontak lensler, liposakin gibi ya dokusunu azaltmak iin kullanilmasi amalanan ekipman, vb.) ynelik (AB) 2022/2346 Sayili ve (AB) 2022/2347 Sayili Uygulama Tzkleri hakkinda duyuru yayimlamitir.
2022/2346 Sayili Uygulama Tz ile (AB) Tibbi Cihaz Ynetmeliinin Ek XVI'sinda listelenen tibbi amali olmayan rn gruplari iin genel gvenlik ve performans gerekliliklerinde belirtilen risk ynetiminin uygulanmasini ele alan ortak spesifikasyonlar dzenlenmitir. lgili Tzk, 22 Aralik 2022 tarihinde yrrle girmi olup tm AB yesi lkeler ve Trkiye'de, 2/3 maddesi yrrlk tarihi itibariyle, dier hkmler ise 23 Haziran 2023 tarihi itibariyle uygulanacaktir.
te yandan, 2022/2347 Sayili Uygulama Tz tibbi amali olmayan belirli aktif rn gruplarinin piyasaya arz edilmesinden nce yapisal riskleriyle tutarli bir uygunluk deerlendirmesini temin etmek amaciyla, (AB) Tibbi Cihaz Ynetmelii'nin Ek XVI'sinda listelenen bazi rn gruplari, ilgili Ynetmelik uyarinca yeniden siniflandirilmitir. Sz konusu Uygulama Tz 22 Aralik 2022 tarihinde yrrle girmitir.
Bu kapsamda, (AB) Tibbi Cihaz Ynetmelii'nin EK XVI'sinda yer alan rnleri piyasaya arz etmek isteyen imalatilarin 2022/2347 ve 2022/2346 sayili Komisyon Uygulama Tzklerinin gerekliliklerini yerine getirmesi, bu kapsamda ilgili alanda yetkin bir onaylanmi kuruluun dahil olduu uygunluk deerlendirme srecini tamamlamasi ve rnleri iin bir CE sertifikasi almasi gerekmektedir.
Duyuru'ya buradan ulaabilirsiniz.
Ayakta Tehis ve Tedavi Yapilan zel Salik Kurululari Hakkinda Ynetmelik
Salik Bakanlii 17 Aralik 2022 ve 7 Ocak 2023 tarihlerinde Ayakta Tehis ve Tedavi Yapilan zel Salik Kurululari Hakkinda Ynetmelikte Deiiklik Yapilmasina Dair Ynetmelik'leri yayimlamitir. Bu kapsamda getirilen balica dzenlemeler aaidaki gibidir:
Hasta haklari ihlali yapildiinin tespit edilmesi halinde ilgili birimin faaliyeti uygun artlar salanana kadar Salik Bakanlii'nin karari zerine Valilike sz konusu birim diindaki hastalarin tani ve tedavi srecini aksatmayacak ekilde geici olarak durdurulacaktir. lgililer hakkinda mevzuat uyarinca idari ve adli ilem yapilacaktir. Ancak sz konusu birimin; acil, tibbi laboratuvar ve grntleme gibi hasta tehis ve tedavisinde hayati nemi haiz birim olmasi halinde birimin, l veya
le Salik Mdrl'nce belirlenecek bir komisyonun gzetimi altinda faaliyet gstermesi salanacaktir.
Salik kuruluunun herhangi bir biriminde veya kisminda hastalarin tedavisini olumsuz etkileyecek bir eksikliin tespiti halinde eksiklik giderilinceye kadar, toplumun veya salik hizmeti alanlarin saliini olumsuz etkileyecei dnlen durumlarin ortaya ikmasi halinde bu durum ortadan kaldirilana kadar ilgili birimin faaliyeti Salik Bakanlii'nin karari zerine Valilike durdurulacaktir.
Muayenehanesi bulunan hekimler, muayenehanesine mracaat eden hastalarin tedavisini yillik szleme yapmak suretiyle ruhsati bulunan tip merkezlerinde gerekletirebilir. Tip merkezleri tarafindan ilgili brantaki toplam kadro sayisinin te birini amayacak ekilde muayenehane hekimleri ile szleme yapilabilir.
7 Ocak 2023 tarihinden nce muayenehanesi bulunan hekimler, szleme yapacaklari tip merkezlerindeki kadro sinirlamasindan muaf tutulacaktir.
17 Aralik 2022 tarihli Ynetmelik'e buradan; 7 Ocak 2023 tarihli Ynetmelik'e buradan ulaabilirsiniz.
Healthcare & Life Sciences Newsletter 15
Healthcare & Life Sciences Newsletter 16
zel Hastaneler Ynetmelii
Salik Bakanlii 17 Aralik 2022 ve 7 Ocak 2023 tarihlerinde zel Hastaneler Ynetmeliinde Deiiklik Yapilmasina Dair Ynetmelik'i yayimlamitir. Bu kapsamda Ayakta Tehis ve Tedavi Yapilan zel Salik Kurululari Hakkinda Ynetmelik ile getirilen yeniliklere paralel dorultuda bir takim deiiklikler yapilmitir. Buna gre getirilen balica dzenlemeler aaidaki gibidir:
Hastanenin herhangi bir biriminde veya kisminda hastalarin tedavisini olumsuz etkileyecek bir eksikliin tespiti halinde eksiklik giderilinceye kadar, toplumun veya salik hizmeti alanlarin saliini olumsuz etkileyecei dnlen durumlarin ortaya ikmasi halinde bu durum ortadan kaldirilana kadar eksiklik tespit edilen ilgili birimin faaliyeti veya zel hastanenin tamaminda faaliyeti Valilike durdurulacaktir.
Hasta haklari ihlali yapildiinin tespit edilmesi halinde ilgili birimin faaliyeti uygun artlar salanana kadar Salik Bakanlii'nin karari zerine Valilike sz konusu birim diindaki hastalarin tani ve tedavi srecini aksatmayacak ekilde geici olarak durdurulacaktir ve ilgililer hakkinda ilgili mevzuati uyarinca idari ve adli ilem yapilacaktir. lgili birimin; acil, tibbi laboratuvar ve grntleme gibi hasta tehis ve tedavisinde hayati nemi haiz birim olmasi halinde birimin, l veya le Salik Mdrl'nce belirlenecek bir komisyonun gzetimi altinda faaliyet gstermesi salanacaktir.
Muayenehanesi bulunan hekimler, muayenehanesine mracaat eden hastalarin tedavisini yillik szleme yapmak suretiyle ruhsati bulunan zel hastanelerde gerekletirebilir. zel hastaneler tarafindan ilgili brantaki toplam kadro sayisinin te birini amayacak ekilde muayenehane hekimleri ile szleme yapilabilir.
7 Ocak 2023 tarihinden nce muayenehanesi bulunan hekimler, szleme yapacaklari zel hastanenin kadro sinirlamasindan muaf tutulacaktir.
17 Aralik 2022 tarihli Ynetmelik'e buradan; 7 Ocak 2023 tarihli Ynetmelik'e buradan ulaabilirsiniz.
Healthcare & Life Sciences Newsletter 17
Diagnostik Radyoloji, Nkleer Tip ve Radyoterapi Grubu Tibbi Cihazlarin Kalite Uygunluk ve Kalite Kontrol Testleri Hakkinda Ynetmelik Hkmlerinin Uygulanmasina likin Kilavuz
Kurum 22 Aralik 2022 tarihinde Diagnostik Radyoloji, Nkleer Tip ve Radyoterapi Grubu Tibbi Cihazlarin Kalite Uygunluk ve Kalite Kontrol Testleri Hakkinda Ynetmelik Hkmlerinin Uygulanmasina likin Kilavuz'unu gncellemitir. Bu kapsamda Kurum'a yapilacak bavurularin elektronik ortamda yapilmasina olanak salayacak deiiklikler getirilmitir. Bu dorultuda getirilen balica dzenlemeler aaidaki gibidir:
(i) Medikal fiziki kalite kontrol alima belgesi ve medikal fiziki kalite uygunluk yazisi bavurularinin e-Devlet Kapisi zerinden elektronik ortamda yapilmasi, (ii) diagnostik radyoloji, nkleer tip ve radyoterapi grubu tibbi cihazlara gerekletirilecek kalite kontrol ve kalite uygunluk testleri ve (iii) kalite uygunluk kuruluu bavurularinin elektronik ortamda Kuruma iletilmesine ilikin i ve ilemler tarif edilmitir.
Kalite kontrol ve kalite uygunluk testleri sonrasi dzenlenecek rapor ierii eklenmitir.
Kilavuz'a buradan ulaabilirsiniz.
Yurt Dii retim Tesislerinin GMP Denetimleri in Yapilacak Mracaatlara Dair Kilavuz
Kurum 27 Aralik 2022 tarihinde Yurt Dii retim Tesislerinin GMP Denetimleri in Yapilacak Mracaatlara Dair Kilavuz'u Dnya Salik rgt tarafindan listelenen dzenleyici otoriteler arasinda yer alma alimalari kapsaminda gncellemitir. Bu kapsamda getirilen balica dzenlemeler aaidaki gibidir:
Pandeminin etkisinin azalmasiyla birlikte Kurum risk esasina dayali olarak yapilacak deerlendirmelere gre yurt dii retim tesislerinde yerinde GMP denetimleri planlayacaktir.
Kilavuz hkmleri erevesinde (i) GMP sertifika geerlilik sresi henz dolmadan risk bazli denetim (yenileme) bavurusu yapilan ve deerlendirme sonucu yerinde denetim karari verilen rnler ve (ii) Kilavuz uyarinca 3. kez yenileme bavuru hakki bulunmayan rnler ile bu rnler referans gsterilerek yapilmi dosya zerinden denetim (muafiyet) bavurusu yoluyla daha ncesinden Kurum'ca GMP sertifikasi dzenlenmi rnler iin GMP sertifikalarinin geerlilik sreleri 1 Haziran 2024 tarihine kadar uzatilmitir.
Sertifika sreleri uzatilan rnlerin GMP sertifikasi kapsaminda deiiklik olmasi durumunda ithalati firmalar tarafindan Kilavuz'a uygun olarak bavuru yapilmasi gerekmektedir.
Kurum tarafindan hibir deerlendirme yapilmami olan ve yerinde denetim karari bulunmayan mevcut GMP sertifikalarin sreleri uzatilmamitir. Bu kapsamda geerlilik sresi Kurum'ca uzatilmayan rnler ve "Yurt Dii GMP Denetimleri ve Sertifikasyon Sreleri Hakkinda Pandemi Srecinde Uygulanacak Ek Tedbirler" isimli duyuru uyarinca GMP sertifikasi dzenlenen rnler haricinde GMP sertifikasi bulunan rnler iin sertifika geerlilik sreleri dolmadan Kilavuz'a uygun olarak risk bazli ve dosya zerinden denetim bavurularinin yapilmasi gerekmektedir.
Yerinde denetim gerekletirilecek tesislerde retilen rnlerin mevcut GMP sertifika geerlilik sreleri denetim sonucuna gre deerlendirilecektir.
Kilavuz'a buradan; Duyuruya ise buradan ulaabilirsiniz.
Beeri Tibbi rnlerin Fiyatlandirilmasi Hakkinda Tebli
Kurum, 31 Aralik 2022 tarihinde Beeri Tibbi rnlerin Fiyatlandirilmasi Hakkinda Teblide Deiiklik Yapilmasina Dair Tebli'i yayimlamitir. Bu kapsamda getirilen balica dzenlemeler aaidaki gibidir:
Maliyet kartina gre fiyat alan rnlerde kartta belirtilen maliyetlerin toplaminin %15 fazlasina kadarki fiyat depocuya sati fiyati olarak belirlenecektir.
Gerek kaynak fiyati tespit edilemeyen ithal alerji rnlerine, maliyetlerinin Trk Lirasi olarak sunulduu, geerlilik sresi 1 yil olan, bavuru sahibi ve yeminli mali mavir tarafindan hazirlanarak onaylanan belge ile fiyat verilebilecektir. Trkiye'de retilen alerji rnlerinden gerek kaynak fiyati tespit edilemeyenler iin maliyet kartina gre fiyat verilebilecektir.
Geleneksel bitkisel tibbi rnler, tibbi aylar, homeopatik tibbi rnler, aromaterapide kullanilan tibbi rnler iin bavuru sahiplerinin beyanina gre fiyat verilebilecektir.
Maliyet karti ile hesaplanan artilar bakimindan mevcut depocuya sati fiyatinin %50'sinden fazla arti yapilamayacaktir.
thal geri demesiz rnler iin gerek kaynak fiyat deiiklik dneminde kendi gerek kaynak fiyatlari sunularak fiyat deiiklii iin bavuru yapilabilir. thal edeer geri demesiz rnlerin kendi fiyati bulunmamasi halinde geri demesiz referans rnn gerek kaynak fiyati, gerek kaynak fiyat olarak belirlenecektir.
Tebli'e buradan ulaabilirsiniz.
Tibbi Cihaz Klinik Aratirmalari Hakkinda Duyuru
Kurum, 11 Ocak 2023 tarihinde tibbi cihaz klinik aratirma bavuru formlarini gncellediini duyurmutur. Bu kapsamda 1 Ocak 2023 tarihinden itibaren yapilacak ilk bavurularda yeni formun kullanilmasi gerekmektedir.
Duyuru'ya buradan ulaabilirsiniz.
Sonu
Kurum salik sektrnde faaliyet gsteren irketlere rehberlik etmeye devam etmektedir. Salik sektrnde faaliyet gsteren tm ilgili irketler, Kurum'un duyurularini yakindan takip etmeli ve mevzuatta yer alan ykmllklerini Kurum'un ynlendirmeleri dorultusunda yerine getirmelidir.
Healthcare & Life Sciences Newsletter 18
Contacts
TEAM /EKIBIMIZ
Can Szer Partner
+90 530 555 3963
Yiit Acar Associate
+90 549 825 77 69
Aya Dou Associate
+90 549 842 78 22
Gizem Nur Yildirim Associate
+90 549 439 02 06
Healthcare & Life Sciences Newsletter 19
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