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სემინარები GMP - ხარისხის სტანდარტზე გადასვლასთან დაკავშირებით | სიახლეები | vidal.ge

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სემინარები GMP - ხარისხის სტანდარტზე გადასვლასთან დაკავშირებით

თარიღი: 03/05/2022

რეგულირების სააგენტო, ფარმაცევტული საწარმოებისთვის, GMP - ხარისხის სტანდარტზე გადასვლასთან დაკავშირებით სემინარებს მართავს

GMP - უსაფრთხო და ეფექტური წამლის წარმოების უზრუნველსაყოფად. კარგი საწარმოო პრაქტიკის (GMP) სტანდარტზე გადასვლასთან დაკავშირებით, სამედიცინო და ფარმაცევტული საქმიანობის რეგულირების სააგენტო, საქართველოში მოქმედ ფარმაცევტულ მწარმოებლებს ხვდება. 4 დღიანი სემინარის ფარგლებში, სააგენტოს ექსპერტები, ფარმაცევტული სექტორის წარმომადგენლებს, GMP სტანდარტზე გადასვლისთვის საჭირო ინფორმაციას მიაწვდიან და მათ შეკითხვებს უპასუხებენ. მოხდება GMP-ის სტანდარტთან შესაბამისობის დადგენის, ასევე სერტიფიკატის გაცემის წესებსა და პირობების გაცნობა.

ღონისძიება ჯანდაცვის მინისტრის პირველმა მოადგილემ, თამარ გაბუნიამ გახსნა. ფარმაცევტული საწარმოების წარმომადგენლებთან შეხვედრას, სამედიცინო და ფარმაცევტული საქმიანობის რეგულირების სააგენტოს დირექტორის მოვალეობის შემსრულებელი კახა შალიკაძე, დირექტორის მოადგილე გიორგი გუნცაძე, წამლის ინსპექტირების სამმართველოს უფროსი ნანა შაშიაშვილი და სააგენტოს ინსპექტორები ესწრებოდნენ.

შეგახსენებთ, რომ ჯანდაცვის სამინისტრომ, მიმოქცევაში არსებული მედიკამენტების ხარისხის უზრუნველყოფის მიზნით, დაიწყო GMP/GDP სტანდარტების დანერგვა. ფარმაცევტულმა საწარმოებმა და დისტრიბუტორებმა ხარისხის სტანდარტზე გადასვლა ეტაპობრივად, 2022 წლის იმ კონკრეტულ თვემდე უნდა შეძლონ, როდესაც ფარმაცევტული პროდუქტის წარმოების ნებართვა აქვთ მიღებული. თუმცა, დამატებითი შეღავათი არის განსაზღვრული იმ მწარმოებლებისთვის, რომლებსაც წარმოების ნებართვის ვადა ივნისის თვემდე აქვთ მიღებული და მათ ხარისხის სერტიფიკატი 30 ივნისამდე უნდა მოიპოვონ.