Expert Pharmacist Sibel GÜRER. Board Chief Supervisor

Transcription

1 T.R. MINISTRY OF HEALTH DIRECTORATE OF THE SUPERVISORY BOARD GMP SUPERVISION APPLICATIONS OF TURKEY Expert Pharmacist Sibel GÜRER Assistant Chairman of the Supervisory Board Chief Supervisor 05/12/ PRESENTATION PLAN-1 DECREE LAW NO. 663 ON STRUCTURE AND DUTIES OF THE MINISTRY OF HEALTH AND AFFILIATED INSTITUTIONS TRANSITION PERIOD DEFINITION ORGANIZATIONAL SCHEME DIRECTORATE OF THE SUPERVISORY BOARD Mission Vision Our Basic Values DUTIES OF THE HEAD OF THE SUPERVISORY BOARD PROCEDURE OF BEING ASSIGNED AS AN INSPECTOR AND THE REQUIRED SKILLS INTRA-SERVICE TRAINING OF THE INSPECTORS GMP SUPERVISIONS FACILITIES BEING SUPERVISED-SUPERVISIONS IN TURKEY TYPES OF SUPERVISION 05/12/

2 PRESENTATION PLAN-2 GMP SUPERVISION PROCESS IN TURKEY RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CARRIED OUT IN TURKEY FACILITIES BEING SUPERVISED-SUPERVISIONS ABROAD ISSUES TO BE CONSIDERED DURING ASSIGNMENT ARRANGEMENT OF THE SUPERVISION APPLICATIONS CONDUCTING OF FOREIGN GMP SUPERVISION ASSIGNMENTS BY THE CHAIRMAN-COMPUTER PROGRAM USED IN THE FOREIGN ASSIGNMENTS GMP SUPERVISION PROCESS ABROAD RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CONDUCTED ABROAD FACTORS EFFECTING THE SUPERVISION PROCESS 05/12/ DECREE LAW NO. 663 Official Gazette No dated Decree Law No. 663 On Structure and Duties of The Ministry of Health and Affiliated Institutions Turkish Drug and Medical Device Institution ARTICLE 27- Turkish Drug and Medical Device Institution has been established with the duty to make regulations on medicines, active and supplementary materials used in production of medicines, substances which are subject to national and international control, medical devices, extra-corporeal medical diagnostic devices, traditional herbal medical products, cosmetic products, homeopathic medical products and dietetic food for special purposes and this institution is working under the Ministry, it has its own private budget and it is apublicadministration. - The authority to supervise regarding the products covered by its field of duty. 05/12/

3 TRANSITION PERIOD PROVISIONAL CLAUSE 1- Ministry and the related institutions harmonize their structure and the personnel with the provisions of the present Decree Law at most within one year. Until the personnel is harmonized with the present decree law, duties given to the Ministry and the affiliated institutions will be realized by units and personnel that have been doing these duties in the past; and expenses and the payments will continue to be made from the relevant budget. PROVISIONAL CLAUSE 2- The regulatory operations mentioned in this decree law shall come into force at most within a year as of the date of publication of thisarticle. ti Until thesaid regulations come into force, application of the provisions of the current regulations, which are not violating the current Decree Law, shall continue to be applied. 05/12/ Until the personnel of our ministry and that of the affiliated institutions are harmonized with the provisions of this Decree Law, (with the condition to be limited to a year) operations and transactions shall be realized by units which were realizing the same in the past and the personnel under the same name of the unit and under the same personnel title. - Current situation; Decree Law No /12/

4 DEFINITION Investigation: As a concept it is used as an examination to understand the original, the right version of doing things or to understand whether things are done right. Ministry of Health assigned Head of the Supervision Board to conduct the investigations. Investigators conduct the supervisions. 05/12/ MINISTER Head of the Supervisory Board Higher Board of Health Private Secretariat Board of Specialty in Medicine Prof. Dr. Nihat TOSUN UNDERSECRETARY Press Consultancy Asst. Prof. Turan BUZGAN Assistant Consultant Ö.Faruk KOÇAK Assistant Consultant Dr. Ekrem ATBAKAN Assistant Consultant Dr. Yasin ERKOÇ Assistant t Consultant t General Directorate of Personnel Drug and Pharmacist General Manager Strategy Development Directorate General Directorate of the EU General Directorate of Health of Customs Coordination Head of Administrative and Financial Affairs Basic Health Services General Manager and Coasts General Directorate of Foreign Affairs SABİM Head of Department of the Fight Against Cancer Department Head of Public Private Partnership Project Management Support Unit Coordinatorship of Transition in Health Head of Department of the Fight Against Tuberculous Coordinatorship of Family Practice Volunteer Health Observers Head of Department of the Fight Against Malaria General Directorate of Treatment Services SGK-SUT Relationship General Directorate of AÇSAP General Directorate of Construction and Unit of Law Draft Written Questions Repair Legal Consultancy Department Head of R.Saydam Public Hygiene Center 05/12/

5 ORGANIZATIONAL SCHEME CHAIRMAN ASSISTANT CHAIRMAN Ankara Center of Duty Chief Supervisor Supervisor Assistant Supervisor İstanbul Center of Duty Chief Supervisor Supervisor Assistant Supervisor İzmir Center of Duty Chief Supervisor Supervisor Assistant Supervisor Branch Directorate of Examination and Interrogation Branch Directorate of Administrive and Financial Affairs 05/12/ MISSION For the basic purposes of protecting the public health and developing health services; in order to make the health sector act in a more efficient, productive, good quality, economical and legal way; To make supervisions by effectively using the modern supervision methods and techniques, To contribute to the creation of new policies for the health sector, To act as a pioneer for training professional administrators and supervisors in the health sector 05/12/

6 VISION With personnel, who have specialized in their fields and who have higher ethical values, to become; Principled, Objective, Fair, Effective, Reliable, Guiding and respective board. 05/12/ OUR BASIC VALUES Legality Objectivity Honesty Independence Vocational Efficiency Quality and Effectiveness Being Open to Novelties Vocational Confidentiality Mutual Respect Participating and Sharing Management Pioneering and Guidance 05/12/

7 DUTIES OF THE HEAD OF THE SUPERVISORY BOARD Directorate of the Supervisory Board realizes the below-mentioned duties upon receiving orders or approval of the Minister: To conduct all kinds of investigation, examination and interrogation operations regarding all activities and operations of the institutions under the Ministry and within the organization of the Ministry, To prepare the necessary proposals and to submit them to the Minister to better realize the purpose of the Ministry and to enable it to function in accordance with the legislation, plan and program, To conduct other duties given with a special law. 05/12/ PROCEDURE OF BEING ASSIGNED AN INSPECTOR AND THE REQUIRED SKILLS Graduated as a doctor, dentist, pharmacist, chemical engineer, chemist or received a bachelors degree in the field of law, politics, economics and business administration. Score Limit of KPSS and Foreign Language Examination Exam with Two Stages (Written and Oral) ASSISTANT SUPERVISOR Training Period for 3 Years 1. Semester (6 months) 2. Semester (1.5 years) 3. Semester (1 year) Proficiency Exam with Two Stages (Written and Oral) SUPERVISOR Working for 10 years for the board, seniority, vocational qualification, effort and success CHIEF SUPERVISOR 05/12/

8 INTRA-SERVICE TRAINING OF THE INSPECTORS Informative meetings organized periodically by the Directorate of Supervisory Board, to which only the supervisors attend, In-service trainings organized by the Directorate of the Supervisory Board periodically, to which all the supervisors attend; moreover, to which participation of specialists from universities, Ministry of Health as well as other public and private institutions is provided, Other trainings organized with the legislation meetings conducted by other units of the Ministry of Health, Trainings organized abroad, Participation to the GMP and GDP training meetings, organized by accredited institutions, To make examination and research about issues related to the fields of duty of the supervisors and to send them to institutions abroad to increase their vocational knowledge. 05/12/ GMP SUPERVISIONS Supervisions regarding the medical industry are being made according to the provisions of the legislation consisting of the GMP rules since 01/11/1984. It has been decided with the Regulatory Approval dated that the GMP Guide should come into force as of 01/01/1995. Afterwards, in order to harmonize the GMP legislation with the EMA and FDA standards, considering the EMA directives and ICH guides, GMP guide has been revised by the General Directorate of Pharmaceuticals and Pharmacy and it has come into force with the Regulatory Approval dated 11/05/2009. Good Manufacturing Practices (GMP) guide has been updated by General Directorate t of Pharmaceuticals and Pharmacy and it has come into force with the Regulatory Approval dated12/08/2011 and numbered On 15/08/2011 it has been published IEGM on the website 05/12/

9 FACILITIES BEING SUPERVISED Supervisions in Turkey: Medication manufacturing facilities, Active ingredient manufacturing facilities, Biological medical product manufacturing facilities, Radio-pharmaceutical manufacturing facilities, Medical gas production, filling, storage and distributionfacilities, Cord blood banks, Stemcell centers, Pharmaceutical warehouses of the representatives. 05/12/ TYPES OF SUPERVISION Inauguration supervisions, Deficiency-monitoring supervisions, Additional activity application supervisions, Periodical supervisions (3 years), Supervisions made upon complaints, Supervisions made upon withdrawal, Supervisions on foreign manufacturing places and active ingredient (for bio-technological products) manufacturing places. 05/12/

10 GMP SUPERVISION PROCESS IN TURKEY General Directorate of Pharmaceuticals and Pharmacy Application is filed before the General Directorate of Pharmaceuticals and Pharmacy of the Ministry by the authorities of the companies which want to enter into service/provide additional service. Said applications are examined by the General Directorate of Pharmaceuticals and Pharmacy and all the documents related to the applications are sent to the Directorate of the Supervision Board in the enclosure of a cover letter. Relevant documents are sent to the Directorate of the Supervision Board regarding issues of deficiencies, periodical supervisions, complaints and withdrawal. Head of the Supervisory Board The letter received from IEGM and all its enclosures are sent to the relevant Assistant Chairman of the Supervisory Board. Necessary examination is made on the letter and its enclosures by the Assistant Chairman of the Supervisory Board. Assistant Chairman assigns the supervisor/supervisors. 05/12/ Head of Supervisor Supervisor/supervisors make an examination on the work order and the enclosed documents. Supervision process Reporting Process; Examination Report is prepared and it is submitted to the Directorate of the Supervisory Board together with its enclosures. Head of the Supervisory Board Reports are examined and evaluated by the relevant Assistant Chairman. If found appropriate, it is sent to the General Directorate of Pharmaceuticals and Pharmacy in the enclosure of the letter of the Ministry. General Directorate of Pharmaceuticals and Pharmacy Reports are read and evaluated and then being processed. Results of the audit are reported to the company being supervised as well as the Health Directorate of the province where the company is located. Things such as preparing permission document, putting an annotation on the permission document of the additional activity and suspension of the document. Correspondences regarding the said transactions of IEGM are done through the Provincial Health Directorates. 05/12/

11 General Directorate of Pharmaceuticals and Pharmacy Deficiencies mentioned in the report of the supervisor are announced both to the Provincial Health Directorates and the company realizing the supervision. Company Deficiencies determined during supervision are satisfied and an application is filed before the Provincial Health Directorate. Provincial Health Directorate Upon application of the company, stating that it satisfied the deficiencies, in accordance with the letter received from IEGM, a report is prepared regarding how the deficiencies have been satisfied in the company and it is reported to IEGM. 05/12/ General Directorate of Pharmaceuticals and Pharmacy Head of the Supervisory Board For a new supervision at the company or evaluation of the proving documents regarding the deficiencies (in accordance with the judgment mentioned in the report), letter of the Provincial Health Directorate and its enclosures are examined and sent to the Directorate of the Supervisory Board. Necessary examination is made on the letter and its enclosures by the Assistant Chairman of the Supervisory Board. Assistant Chairman/Chairman assigns the supervisor/supervisors to make the supervision/evaluation. ation Supervisor According to the results of the supervision/evaluation carried out by the supervisors, the report/letter is forwarded to the Directorate of the Supervisory Board in written. Head of the Supervisory Board Reports/letters are examined and evaluated by the relevant Assistant Chairman. If reports/letters are found appropriate, they are sent to the General Directorate of Pharmaceuticals and Pharmacy in the enclosure of the letter of the Ministry so that the necessary operations can be done. 05/12/

12 RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CARRIED OUT IN TURKEY A- Inauguration-Additional Activity Supervisions; It is suggested that the company can start the activities/additional activities it mentioned in its application and permission document can be prepared for these activities, If there are deficiencies which prevent it to act, the company is supervised again/document is considered again and then it can be decided whether the firm can start its activities/additional activities, 05/12/ RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CARRIED OUT IN TURKEY B- Periodical Supervision- Supervisions Made Upon Complaint and Withdrawal; It is suggested tdthatt there is not any drawback topreventt its activities, iti Although there is not any drawback to prevent it from continuing its activities, there are deficiencies which need to be satisfied and they should be satisfied (Upon sending of the proving documents, they can be evaluated by the Supervisor, another Supervisor audit and it can be left to the next supervision), Until the violations in the permissions of the facilities are satisfied, they are suspended or the permissions are canceled completely for all or some activities, Application of administrative and judicial operations, 05/12/

13 FACILITIES BEING SUPERVISED Foreign Supervisions: Humanitarian medical product manufacturing facilities, Active ingredient manufacturing facilities (for biotechnological products). 05/12/ ISSUES TO BE CONSIDERED DURING ASSIGNMENT 1- Being fair, 2- To provide priority, very fast supervision of very critical-critical group of medicines, 3- To assign the personnel based on the date of receipt of the applications by the Ministry, which are included in the same classification, according to the classification given by the Ministry, 4- To assign the supervisors based on the topics they have been specialized on, 5- To providea just distribution of the countries where they have been assigned and their terms of duties among the supervisors. 6-To provide that the assistant supervisors are assigned with different supervisors during their training term. 05/12/

14 ARRANGEMENT OF THE SUPERVISION APPLICATIONS In the decision called "Scientific Criteria Suggested for GMP Control Listing" of the Licensing-Consulting Commission of Humanitarian Medical Products, formed within the General Directorate of Pharmaceuticals and Pharmacy; Evaluation criteria have been set for the control priorities of the products such as 1-Very critical, 2-Critical, 3-Not critical, 4-Nonpriority by classifying the same just like that. Since every number come before the other numbers that are bigger than that, the said priority listing shall be taken into consideration in the planning to be made for the GMP supervision of the facilities abroad. 05/12/ ARRANGEMENT OF THE SUPERVISION APPLICATIONS Letter of the Ministry sent to the Supervisors: Letter of the General Directorate of Pharmaceuticals and Pharmacy and the classifications of the application files sent in the enclosure have been sent to all the supervisors; While GMP supervision listing is being awaited by the supervisors; It has been requested that the issues mentioned in the decision called "Scientific Criteria Suggested for GMP Control Listing" of the Licensing- Consulting Commission of Humanitarian Medical Products, mentioned in the letter written by IEGM, Date of work order is taken into consideration regarding the products included in the same class, If joint supervisors have been assigned, in case of overlapping of the supervision dates because of the fact that the other supervisor has been assigned to work with another supervisor at the said date planning shall be done upon considering the priority listing, If the priority listing of the importing company cannot be followed because of problems, resulting from the importing company's excuses such as repair or holiday at the facilities to be supervised, this fact shall be reported to the Ministry in written, including the correspondences made with the exporting company, 05/12/

15 CONDUCTING OF FOREIGN GMP SUPERVISION ASSIGNMENTS BY THE CHAIRMAN In the letter received from the General Directorate of Pharmaceuticals and Pharmacy; information regarding the name of the importing company, name(s) of the product(s) subject to supervision, form of the pharmaceutical, the production facility to be supervised and the country where the facility is located as well as the classification information of the products. The received letters shall be recorded by the document unit of the Directorate of the Supervisory Board and then shall be sent to the relevant Assistant Chairman. The letters, received by the Directorate, are recorded in the computer media, according to the date of receipt from IEGM. 05/12/ COMPUTER PROGRAM USED IN THE FOREIGN ASSIGNMENTS General Directorate of Drugs and Pharmaceuticals Date and Number Name of the Country To Be Supervised Supervision Dates Facilities to Be Supervised Importing Company Products to be Supervised Specifications of the Product Classification of the product (level of criticality) 05/12/

16 CONDUCTING OF FOREIGN GMP SUPERVISION ASSIGNMENTS BY THE CHAIRMAN Listing on the table is rearranged depending on the classification of the products (1, 2, 3, 4 generic, first generic). Product applications included in the same application are listed according to the date of the letters received from IEGM. Scanning is made; Re, Name of the facilities to be supervised, Name of the product, Name of the country. 05/12/ CONDUCTING OF FOREIGN GMP SUPERVISION ASSIGNMENTS BY THE CHAIRMAN As a result of the conducted scan, It is determined whether there is any pending/assigned application before the Directorate of the Supervisory Board regarding the facility for which a new supervision demand has been filed. Information is obtained about which supervisor it has been given as a working order. It is determined whether it is necessary to make a new assignment. 05/12/

17 Foreign GMP assignments made by the Ministry 1- Assignments regarding the same facility 2- Assignments regarding different facilities within the same country 3- Assignments made in case different stages of production are in different facilities 4-Assignments regarding the biotechnological products 5- Assignments regarding alternative 05/12/2011 production/manufacturing stages ASSIGNMENTS REGARDING THE SAME FACILITY Assignments Regarding the Same Facility In those cases supervision has not been done During supervision Upon completion of the supervision 05/12/

18 1- ASSIGNMENTS REGARDING THE SAME FACILITY A- In those cases supervision has not been done A1- If regulatory approval has not yet been received; the newly received supervision demand is united with the working order of this supervisor. While uniting them, criticality levels of the products (1, 2, 3, 4, etc.) is not taken into consideration. A2- If the regulatory approval has been received; an evaluation is made about whether the new application is going to extend the supervision process based on the pharmaceutical form of the product and upon discussing with the supervisor. If it is decided that the supervision period cannot be extended; the newly received supervision demand is united with the working order of this supervisor. While uniting them, criticality levels of the products (1, 2, 3, 4, etc.) is not taken into consideration. If it is decided that the supervision period shall be extended; a different supervisor can be assigned. 05/12/ ASSIGNMENTS REGARDING THE SAME FACILITY B- During supervision; Considering that there is application which shall not extend the planned supervision process, the remaining days of supervision, meeting with the supervisor(s) making the supervision, it is (not) assigned to the same supervisor. In this kind of assignments; - Classification of the product and whether the importing companies are the same are not taken into consideration. - Working order is notified to the supervisor, upon the assignment, who is abroad. 05/12/

19 1- ASSIGNMENTS REGARDING THE SAME FACILITY C- Upon completion of the supervision With the products being supervised by the supervisor in the new application; - Same line -Same environment, - Same equipment - Different line, - Different environment, - Different equipment Same supervisor Different/Same supervisor Evaluation Supervision 05/12/ ASSIGNMENTS REGARDING DIFFERENT FACILITIES WITHIN THE SAME COUNTRY Assignment is done in a way not to be more than 3 weeks (2-3 facilities). Classification of the products is taken into consideration in the assignment. 05/12/

20 3- ASSIGNMENTS MADE IN CASE DIFFERENT STAGES OF PRODUCTION ARE IN DIFFERENT FACILITIES A- If a supervisor has been assigned regarding one of the facilities where there is conducted the production stages; the new working order can completely be given to this new supervisor. If the new work which covers different production stages does not have priority over the work which has been assigned beforehand; production stage is supervised regarding the facility, supervision of which has been planned. Supervision of the other stages is done during their own classification. B- If supervision of the facilities where production stages are conducted is assigned to more than one supervisor; the new working order can be given to these supervisors upon bi being dividedid d into production stages. C- If there is not any assignment regarding the facilities, production stages of which have been conducted; a single supervisor/team of supervisors can be assigned in a way to cover all the production stages. (Exception; distant countries, supervision demands regarding which are filed very rarely) 05/12/ ASSIGNMENTS REGARDING THE BIOTECHNOLOGICAL PRODUCTS Assignments Regarding the Biotechnological Products The fact that the active ingredient production facility and the finished product production facility are the same The fact that the active ingredient production facility and the finished product production facility are different (two or more) Same country Different country 05/12/

21 4- ASSIGNMENTS REGARDING THE BIOTECHNOLOGICAL PRODUCTS A- If the active ingredient production facility and the finished product production facility are the same (in one facility); The same supervisor is assigned. 05/12/ ASSIGNMENTS REGARDING THE BIOTECHNOLOGICAL PRODUCTS B- If the active ingredient production facility and the finished product production facility are different (in 2 or more facilities); Assignment is done considering the product classification of the supervision in a way to provide that it is done at the same time/close to each other. 1- Same Country; The same supervisor is assigned. 2- Different Country; The same supervisor and/or different supervisor is assigned. 05/12/

22 5- ALTERNATIVE PRODUCTION-ASSIGNMENTS REGARDING THE PRODUCTION STAGES There is not any requirement stating that supervision of the production, primary packaging, g, etc. facilities of one product shall be done by the same supervisors who supervise the alternative bulk production, primary packaging facilities. A- If there is a supervisor assigned for the supervision of the alternative production facility, working order can be given to this supervisor. B-If there is a supervisor assigned for supervision in the same country, working order can be given to this supervisor, considering the classification. (If the term of duty is more than 3 weeks) C- If supervisors have not been assigned for supervision in the same facilities or in the same country; new assignment is made 05/12/ GMP SUPERVISION PROCESS ABROAD General Directorate of Pharmaceuticals and Pharmacy Company's application Examination upon application and completing the Forwarding of the files necessary for GMP supervision regarding the appropriate applications to the Directorate of the Supervisory Board Head of the Supervisory Board Necessary examination is made on the letter and its enclosures by the relevant Assistant Chairman of the Supervisory Board. Paraphof the Assistant Chairman of the Supervisory Board, signature of the Chairman and assignment of the supervisor(s) Giving written working order to the supervisor 05/12/

23 Supervisor/ Supervisors Examination of the working order and the enclosed files (product specifications, assignment process according to the pharmaceutical forms) A letter shall be written by the supervisors to the authorities of the company; - Requesting research about whether there is a special condition regarding the supervision processes of the country which will be supervised - Moreover, asking for determination of the supervision dates by reaching a consensus with the authorities of the production facilities to be supervised Provision of written information by the importing company to the supervisor (date of supervision, special condition, etc.). 05/12/ Supervisor/ Supervisors Indicating whether the date of supervision is appropriate for the supervisor by sending a letter to the importing company by the supervisor. Requesting supply of the invitation letter from the foreign company, which is going to be audited, including the road process (if the company does not have a special condition for application). Provision of information to the Directorate of Supervision Board by the supervisor(s) (date of supervision, whether the country to be visited has a special condition for application, invitation letter) 05/12/

24 Head of the Supervisory Board Sending of the letter of the Supervisor as well as its enclosures by the Directorate of the Supervisory Board to the Directorate of Foreign Affairs of the Ministry and provision of the regulatory approval Moreover, if the company has a special application condition, asking for the necessary action to be taken General Directorate of Foreign Affairs Receiving the regulatory approval and forwarding the same to the Directorate of the Supervisory Board Head of the Supervisory Board Serving of the regulatory approval to the supervisor(s) Supervisor/ Supervisors Buying of the tickets for the country that is going to be gone by the supervisor(s) and completion of the visa procedures, if necessary 05/12/ Supervisor/ Supervisors Detailed examination of the application files in the enclosure of the working order from the date when the working order is received until the actual date of supervision by the supervisors Supervision process - DOF process Reporting Process (Examination Report, abroad report. Submission report to the Minister) Submission of 3 reports and their enclosures together with the cover letter to the Directorate of the Supervisory Board Head of the Supervisory Board Examination and evaluation of the reports by the relevant Assistant Chairman If found appropriate, together with the paraph of the Assistant Chairman, signature of the Chairman, in the enclosure of the cover letter; sending of the examination report to the General Directorate of Pharmaceuticals and Pharmacy of our Ministry, abroad report and the report to be submitted to the Minister to the Head of the Office of Foreign Affairs of our Ministry 05/12/

25 General Directorate of Pharmaceutical s and Pharmacy Reporting of the result of the supervision to the importing company by the General Directorate of Pharmaceuticals and Pharmacy of our Ministry (requesting of some issues such as satisfying the deficiencies, sending of the proving documents) Importing Company Reporting of the results of supervision to the manufacturing company, which have been reported to them by General Directorate of Pharmaceuticals and Pharmacy Requesting the necessary information and documents from the production company and submission of the same to the General Directorate General Directorate of Pharmaceutical s and Pharmacy Sending of the documents reported to IEGM upon being provided from the production company by the importing company to the Directorate of the Supervisory Board Head of the Supervisory Board Submission of the documents, received from the General Directorate of Pharmaceuticals and Pharmacy in the enclosure of the working order to the supervisor, who is making the supervision in order to be evaluated Sending of the letter, consisting of the evaluation of the supervisor to IEGM for the necessary action to be taken 05/12/ RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CONDUCTED ABROAD-1 Production place of the product(s) which are subject to supervision are appropriate for GMP. (GMP certificate +) Production place of the product(s) which are subject to supervision are appropriate for GMP. However, upon satisfaction of the deficiencies identified during supervision (. article) it is necessary for the proving documents to be sent to our Ministry and to be evaluated by IEGM. (GMP certificate +) Production place of the product(s) which are subject to supervision are generally appropriate for GMP. GMP certificate can be issued and the licensing process can be finalized; however, before granting the sales permission the deficiencies, determined during the supervision, shall be completed. Supervisor/IGM evaluation. (GMP certificate +) 05/12/

26 RESULTS OF THE REPORTS REGARDING THE SUPERVISIONS CONDUCTED ABROAD-2 At the manufacturing place of the product(s), which are subject to supervision,..article have been determined to be deficient and the production place is not appropriate for GMP. (GMP certificate -) Production place of the product(s) which are subject to supervision are generally appropriate for GMP. However, upon satisfaction of the deficiencies identified during supervision (. article), the final decision shall be given upon evaluation of the proving documents by the supervisor who did the supervision. (GMP certificate -/+ or -) 05/12/ THANK YOU FOR YOUR ATTENTION 05/12/