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Anti Drugs22.Pdf الجمعة 10 صفر 1440 هـ 19 أكتوبر 2018 م UM AL-QURA 12 ال�سنة 96 العدد 4749 قـرارات و أنظـمـة 96 لئحة رقابة الأجهزة واملنتجات الطبية .. تتمة ج . ﻻ يوؤثر ذلك على التزام الهيئة يف تبادل املعلومات والتنبيهات التي ت�ساعد على تعزيز ال�سحة العامة. الالئحة ومنها على سبيل المثال: د . ﻻ يوؤثر ذلك على م�سوؤوليات اﻻأ�سخا�ش املهتمني بتقدمي املعلومات يف احلاﻻت اجلنائية. اأ . اإيقاف الرتخي�ش موؤقتاً. ًثانيا: الدعاية واإلعالن لألجهزة والمنتجات الطبية ب. اإلغاء الرتخي�ش. المادة الحادية واألربعون: ج. �سحب املنتج واإيقاف تداوله. د . اإلغاء اﻻإذن بالت�سويق. اأ . ﻻ يجوز اإ�سدار اأي مادة دعائية اأو اإعﻻنية لﻻأجهزة واملنتجات الطبية اإﻻ اإذا كانت حا�سلة على اﻻإذن بت�سويقها من الهيئة. المادة الثالثة واألربعون: ب. يجب اأخذ موافقة الهيئة على �سيغة املادة الدعائية اأو اﻻإعﻻنية. تن�سر الهيئة املقابل املايل لدرا�سة طلبات اﻻإذن بت�سويق اﻻأجهزة واملنتجات الطبية. ج. يجب اأن ﻻ حتتوي الدعاية واﻻإعﻻن على اأي معلومات م�سللة للم�ستخدم عن اإمكانات اﻻأجهزة واملنتجات الطبية املحددة من قبل امل�سنع. المادة الرابعة واألربعون: د . يجب جتنب التغرير بامل�ستخدم العادي يف املواد الدعائية واﻻإعﻻنية واملن�سورات املوجهة ت�ستويف الهيئة املقابل املايل لرتاخي�ش من�ساآت اﻻأجهزة واملنتجات الطبية بحد اأق�سى قدره خم�سة للمجتمع مبا يف ذلك املعلومات على ال�سبكة العنكبوتية. وثﻻثون األف ريال )35.000 ريال( وفق ت�سنيف من�ساآت اﻻأجهزة واملنتجات الطبية الذي يعده قطاع هـ . بجب اأن حتتوي املواد الدعائية واﻻإعﻻنية واملن�سورات املوجهة لﻻأ�سخا�ش املعنيني با�ستخدام اﻻأجهزة واملنتجات الطبية بالهيئة. الهيئة العامة للغذاء والدواء اﻻأجهزة واملنتجات الطبية على املعلومات املتوافقة مع احتياجاتهم. المادة الخامسة واألربعون: و . يجب اأن يكون لدى اﻻأ�سخا�ش املعنيني بت�سويق اﻻأجهزة واملنتجات الطبية املعلومات الكافية عنها مبا يكفل تقدمي املعلومات ال�سحيحة اخلا�سة بت�سويقها. تقوم الهيئة بو�سع ون�سر القواعد اﻻإجرائية املكملة لهذه الﻻئحة والتي حتدد اﻻ�سرتاطات اخلا�سة بها وتاريخ �سريان كل من القواعد اﻻإجرائية واملواد ذات العﻻقة يف هذه الﻻئحة. )الفصل الحادي عشر( المادة السادسة واألربعون: يتم البدء يف اإ�سدار اﻻإذن بالت�سويق بعد �ستني يوماً من ن�سر القواعد اﻻإجرائية اخلا�سة بالف�سل أحكام ختامية ال�ساد�ش من هذه الﻻئحة. المادة الثانية واألربعون: المادة السابعة واألربعون: للهيئة اتخاذ اإلجراءات المناسبة عند مخالفة أي حكم من أحكام هذه تن�سر هذه الﻻئحة يف اجلريدة الر�سمية ويعمل بها بعد ت�سعني يوماً من تاريخ ن�سرها. اأحكام عامة على اجلداول املرفقة بنظام مكافحـة املخـدرات واملـوؤثرات العقـليـة المواد المخدرة : ا�ستعمالها اأو اﻻجتار بها اأو توزيعها اأو و�سفها اأو حيازتها باأي و�سيلة كانت، ويقت�سر ا�ستخدامها على اﻻأبحاث الطبية والعلمية فقط، بعد اأخذ موافقة قطاع الدواء يف الهيئة أوال : اجلدول اﻻأول ي�سمل املواد املخدرة وينق�سم اإىل خم�ش فئات على النحو التايل : العامة للغذاء والدواء . 1. فئة ) اأ ( ت�سم املواد املخدرة املدرجة يف اجلدول اﻻأول ﻻتفاقية اﻻأمم املتحدة لعام 1961م . ً 2. فئة ) ب ( ت�سم املواد املخدرة املدرجة يف اجلدول الثاين ﻻتفاقية اﻻأمم املتحدة لعام 1961م . رابعا : املوؤثرات العقلية التالية : 3. فئة ) ج ( ت�سم املواد املخدرة املدرجة يف اجلدول الثالث ﻻتفاقية اﻻأمم املتحدة لعام 1961م . FENETYLLINE .1 4. فئة ) د ( ت�سم املواد املخدرة املدرجة يف اجلدول الرابع ﻻتفاقية اﻻأمم املتحدة لعام 1961م . METHAQUALONE .2 5. فئة ) هـ ( ت�سم املواد املخدرة املراقبة حمليا ًباململكة . SECOBARBITAL .3 الواردة يف الفئة ) ب ( من اجلدول الثاين، يحظر ا�ستريادها اأو ت�سديرها اأو اإنتاجها اأو �سنعها ًثانيا : الفئات )اأ،ب،ج،د( يف اجلدول اﻻأول املذكورة اأعﻻه تعرف بالقائمة ال�سفراء والتي ت�سدر اأو ا�ستعمالها اأو اﻻجتار بها اأو توزيعها اأو و�سفها اأو حيازتها باأي و�سيلة كانت، ويقت�سر عن الهيئة الدولية ملراقبة املخدرات . ا�ستخدامها على اﻻأبحاث الطبية والعلمية فقط، بعد اأخذ موافقة قطاع الدواء يف الهيئة العامة ًثالثا : فئة ) د ( من اجلدول اﻻأول، يحظر ا�ستريادها اأو ت�سديرها اأو اإنتاجها اأو �سنعها اأو للغذاء والدواء . ا�ستعمالها اأو اﻻجتار بها اأو توزيعها اأو و�سفها اأو حيازتها باأي و�سيلة كانت، ويقت�سر ًً ا�ستخدامها على اﻻأبحاث الطبية والعلمية فقط بعد اأخذ موافقة قطاع الدواء يف الهيئة خامسا : املوؤثرات العقلية التالية : العامة للغذاء والدواء . EPHEDRINE .1 ًرابعا : امل�ستح�سرات ال�سيدﻻنية التي ﻻ تخ�سع لنظام مكافحة املخدرات واملوؤثرات العقلية ETHANOL .2 ويكون اأحد مكوناتها 8 ملجم كوديني فاأقل وب�سكل �سيدﻻين اأقرا�ش اأو كب�سوﻻت فقط، NOREPHEDRINE .3 فاإنها تكون من اﻻأدوية التي ت�سرف بو�سفة طبية وﻻ تطبق عليها اﻻأحكام الواردة يف نظام الواردة يف الفئة ) هـ ( من اجلدول الثاين اإذا كانت على �سكل �سيدﻻين وللعﻻج الطبي فاإنها تخ�سع مكافحة املخدرات واملوؤثرات العقلية، ولكن تطبق عليها اﻻأحكام الواردة يف نظام املن�ساآت للرقابة وتطبق عليها اﻻأحكام الواردة يف نظام مكافحة املخدرات واملوؤثرات العقلية، اأما امل�ستح�سرات وامل�ستح�سرات ال�سيدﻻنية وﻻئحته التنفيذية. ال�سيدﻻنية التي يكون اأحد مكوناتها اإحدى هذه املواد فاإنها ﻻ تخ�سع للرقابة وﻻ تطبق عليها اﻻأحكام المؤثرات العقلية : الواردة يف نظام مكافحة املخدرات واملوؤثرات العقلية، ولكن يطبق عليها نظام املن�ساآت وامل�ستح�سرات ال�سيدﻻنية وﻻئحته التنفيذية . وماعدا ذلك فتطبق عليها اﻻأحكام الواردة يف نظام ا�سترياد املواد ًأوال : اجلدول الثاين ي�سمل املوؤثرات العقلية وينق�سم اإىل خم�ش فئات على النحو التايل : الكيميائية واإدارتها ال�سادر بقرار جمل�ش الوزراء املوقر رقم )143( وتاريخ 14-6-1427هـ وامل�سادق 1. فئة ) اأ ( ت�سم املوؤثرات العقلية املدرجة يف اجلدول اﻻأول ﻻتفاقية اﻻأمم املتحدة لعام 1971م . عليه باملر�سوم امللكي الكرمي رقم )م/38( وتاريخ 16-6-1427هـ . 2. فئة ) ب ( ت�سم املوؤثرات العقلية املدرجة يف اجلدول الثاين ﻻتفاقية اﻻأمم املتحدة لعام 1971م . 3. فئة ) ج ( ت�سم املوؤثرات العقلية املدرجة يف اجلدول الثالث ﻻتفاقية اﻻأمم املتحدة لعام 1971م . ًسادسا : امل�ستح�سرات ال�سيدﻻنية التي حتتوي على مادة خمدرة وموؤثر عقلي تعامل كمادة 4. فئة ) د ( ت�سم املوؤثرات العقلية املدرجة يف اجلدول الرابع ﻻتفاقية اﻻأمم املتحدة لعام 1971م . خمدرة . ً 5. فئة ) هـ ( ت�سم املوؤثرات العقلية املراقبة حمليا باململكة. ًسابعا : تعامل املواد القيا�سية التي حتتوي مواد خمدرة اأو موؤثرات عقلية معاملة املادة التي ًًثانيا : الفئات )اأ،ب،ج،د( يف اجلدول الثاين املذكورة اأعﻻه تعرف بالقائمة اخل�سراء والتي ت�سدر حتتويها . عن الهيئة الدولية ملراقبة املخدرات . ًثامنا : كوا�سف املواد املخدرة واملوؤثرات العقلية، ﻻ تخ�سع للرقابة وﻻ تطبق عليها اﻻأحكام ًثالثا : فئة ) اأ( من اجلدول الثاين، يحظر ا�ستريادها اأو ت�سديرها اأو اإنتاجها اأو �سنعها اأو الواردة يف نظام مكافحة املخدرات واملوؤثرات العقلية، وتعامل معاملة الكوا�سف العادية الجمعة 10 صفر 1440 هـ 19 أكتوبر 2018 م UM AL-QURA 96 قـرارات و أنظـمـة ال�سنة 96 العدد 4749 13 اأحكام عامة على اجلداول املرفقة بنظام مكافحة املخـدرات واملـوؤثرات العقلية .. تتمة ويكون ف�سحها عن طريق قطاع اﻻأجهزة واملنتجات الطبية يف الهيئة العامة للغذاء والدواء. 1. فئة ) اأ ( ت�سم ال�سﻻئف الكيميائية املدرجة يف اجلدول اﻻأول ﻻتفاقية اﻻأمم املتحدة لعام 1988م . السالئف الكيميائية: 2. فئة ) ب ( ت�سم ال�سﻻئف الكيميائية املدرجة يف اجلدول الثاين ﻻتفاقية اﻻأمم املتحدة لعام 1988م . البذور والنباتات: الجدول الثالث يشمل السالئف الكيميائية وينقسم إلى فئتين على اجلدول الرابع ي�سمل النباتات والبذور املحظورة واأي جزء منها ويف جميع اأطوار منوها وعلى اأي �سكل النحو التالي: كانت اأو وجدت . اجلدول الأول ) املواد املخدرة ( فئة ) أ ( : ) هي المواد المخدرة المدرجة في الجدول األول التفاقية 1961م ( املادة املخدرة Narcotic drugs Description/Chemical name الهيئة العامة للغذاء والدواء 3-O-acetyltetrahydro-7α-(1-hydroxy-1-methylbutyl)-6,14-endo- اأ�سيتورفني Acetorphine .1 ethenooripavine (derivative of thebaine) اأ�سيتيل-األفا-ميثيل فنتانيل Acetyl-Alpha-Methylfentanyl N-[1-(α -methylphenethyl)-4-piperidyl]acetanilide .2 ا�سيتيل فنتانيل Acetylfentanyl N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide .3 اأ�سيتيل ميثادول Acetylmethadol 3-acetoxy-6-dimethylamino-4,4-diphenylheptane .4 اأكريلويل فينتانيل Acryloylfentanyl N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide .5 N-[1-[2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1-yl)ethyl]- األفنتانيل Alfentanil .6 4-(methoxymethyl)-4-piperidinyl]-N-phenylpropanamide اى ام - AH-7921 3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide 7921 .7 األيل برودين Allylprodine 3-allyl-1-methyl-4-phenyl-4-propionoxypiperidine .8 األفا�سيتيل ميثادول Alphacetylmethadol α-3-acetoxy-6-dimethylamino-4,4-diphenylheptane .9 األفاميربودين Alphameprodine α-3-ethyl-1-methyl-4-phenyl-4-propionoxypiperidine .10 األفاميثادول Alphamethadol α-6-dimethylamino-4,4-diphenyl-3-heptanol .11 األفا-ميثيل فنتانيل Alpha-Methylfentanyl N-[1-( α-methylphenethyl)-4-piperidyl]propionanilide .12 األفا-ميثيل تيوفنتانيل Alpha-Methylthiofentanyl N-[1-[1-methyl-2-(2-thienyl)ethyl]-4-piperidyl]propionanilide .13 األفابرودين Alphaprodine α-1,3-dimethyl-4-phenyl-4-propionoxypiperidine .14 اأنيلرييدين Anileridine 1-p-aminophenethyl-4-phenylpiperidine-4-carboxylic acid ethyl ester .15 بنزيتيدين Benzethidine 1-(2-benzyloxyethyl)-4-phenylpiperidine-4-carboxylic acid ethyl ester .16 بنزيل مورفني Benzylmorphine 3-benzylmorphine .17 بيتا�سيتيل ميثادول Betacetylmethadol β-3-acetoxy-6-dimethylamino-4,4-diphenylheptane .18 بيتا-هيدروك�سي فنتانيل Beta-Hydroxyfentanyl N-[1-(β-hydroxyphenethyl)-4-piperidyl]propionanilide .19 بيتا-هيدروك�سي- 3-ميثيل فنتانيل Beta-Hydroxy-3-Methylfentanyl N-[1-(β-hydroxyphenethyl)-3-methyl-4-piperidyl]propionanilide .20 بيتاميربودين Betameprodine β-3-ethyl-1-methyl-4-phenyl-4-propionoxypiperidine .21 بيتاميثادول Betamethadol β-6-dimethylamino-4,4-diphenyl-3-heptanol .22 بيتابرودين Betaprodine β-1,3-dimethyl-4-phenyl-4-propionoxypiperidine .23 الجمعة 10 صفر 1440 هـ 19 أكتوبر 2018 م UM AL-QURA 14 ال�سنة 96 العدد 4749 قـرارات و أنظـمـة 96 اأحكام عامة على اجلداول املرفقة بنظام مكافحة املخـدرات واملـوؤثرات العقلية .. تتمة 1-(3-cyano-3,3-diphenylpropyl)-4-(2-oxo-3-propionyl-1-benzimidazolinyl) بيزيرتاميد Bezitramide .24 piperidine بيوتايرفينتانيل Butyrfentanyl N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]butanamide .25 Cannabis and cannabis resin ّالقنب وراتنج ّالقنب وخﻻ�سات 26. and extracts and tinctures of Indian hemp and resin of Indian hemp واأ�سباغ ّالقنب cannabis (4-((1-oxopropyl)-phenylamino)- 1-(2-phenylethyl)- 4-piperidinecarboxylic كارفينتانيل Carfentanil .27 acid methyl ester) الهيئة العامة للغذاء والدواء كلونيتازين Clonitazene 2-(p-chlorobenzyl)-1-diethylaminoethyl-5-nitrobenzimidazole .28 the leaf of the coca bush (plant material), except a leaf from which all 29.
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