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document_type=executive_regulation entity=format:application/pdf entity=amendment:true entity=language:ar language=mixed taxonomy_l1=economy_finance taxonomy_l2=insurance validity=valid validity_confidence=0.6
# الهييه العامه للغذاء والدواء
## Saudi Food & Drug Authority

اليه الاستبدال والاحلال للادويه المسجله في
الهييه العامه للغذاء والدواء

النسخه رقم ٢,٠

| تاريخ الاصدار |
|---|
| ۱۲ يناير ۲۰۲۱ |

DS-G-056-V02-210112
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# اليه الاستبدال والاحلال للادويه المسجله في
# الهييه العامه للغذاء والدواء

النسخه رقم ٢,٠

الهييه العامه للغذاء والدواء
قطاع الدواء

الرجاء زياره موقع الهييه العامه للغذاء والدواء
https://www.sfda.gov.sa/ar/regulations?tags=2

للحصول علي مزيد من المعلومات

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DS-G-056-V02-210112
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# الهييه العامه للغذاء والدواء

## الرؤيه والرساله

### الرؤيه
ان تكون هييه رايده عالميا تستند الي اسس علميه لتعزيز وحمايه الصحه العامه

### الرساله
حمايه المجتمع من خلال تشريعات ومنظومه رقابيه فعاله لضمان سلامه الغذاء والدواء والاجهزه الطبيه ومنتجات التجميل والمبيدات والاعلاف

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DS-G-056-V02-210112

# توثيق المستند

| ملاحظات | الناشر | التاريخ | النسخه |
|---|---|---|---|
| نسخه نهاييه | قطاع الدواء | ۱۲ يناير ۲۰۲۱ | ۱ |
| نسخه نهاييه | الاداره التنفيذيه لتقييم المنافع والمخاطر | ٢٦ فبراير ٢٠٢٣ | ۲ |

DS-G-056-V02-210112
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• ما هو التحديث في هذه النسخه (رقم ٢٠ ) ؟

فيما يلي جدول يوضح التحديثات:

| العنوان | نوع التحديث |
|---|---|
| تعريفات | **اضافه:** تم اضافه التعريفات التاليه: <br> - الدواء المبتكر: (Innovative Drug) <br> - الدواء الجنيس: (Generic Drug) <br> - الدواء الحيوي: (Biological Drug) <br> - الدواء الحيوي المشابه: (Biosimilar Drug) <br> - الادويه ذات النطاق العلاجي الضيق: (Narrow Therapeutic Index Drugs) |
| | **اضافه:** تم اضافه نقطه رقم 1 عمليه الاستبدال الدوايي وما يصاحبها من اجراءات هي من اختصاص المستشفيات ومقدمي الرعايه الصحيه، ومن هذه الاجراءات علي سبيل المثال لا الحصر مراقبه فعاليه ومامونيه الدواء علي المريض من قبل الممارس الصحي خلال فتره استبدال الدواء. <br> في النقطه الرابعه تم اضافه <br> كما يجب علي الجهات المسؤوله عن الشراء والترسيه الاخذ بعين الاعتبار الامكانيات المتوفره لدي الجهات الصحيه لمتابعه المريض وتوصيات الجهه الصحيه قبل اتخاذ قرار الاحلال الدوايي للمستحضرات |
| التوصيات العامه | **تحديث:** تم تحديث النقاط التاليه: <br> **اضافه:** <br> اولا: الادويه الفمويه ذات النطاق العلاجي الضيق (Narrow Therapeutic Index Drugs) <br> - الادويه البيولوجيه بجميع انواعها <br> - الادويه المستنشقه (Inhalers) <br> - ادويه الصرع <br> **اضافه:** تم اضافه النقطه الخامسه <br> في حاله ظهور الاعراض الجانبيه او خلل في جوده المستحضرات الصيدلانيه، القيام برفع بلاغ للهييه للعامه للغذاء والدواء عبر خدمه تيقظ |

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# الفهرس

تعريفات: 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