The Mobilisation of Reserve Medicines and Medical Devices Regulations
1.中華民國九十一年九月二十六日行政院衛生署衛署醫字第 0910049422 號令、國防部(九一)鐸錮字第 001396 號令會銜訂定發布全文 10 條 ;並自發布日施行 中華民國一百零二年七月十九日行政院院臺規字第 1020141353 號公告 第 9 條所列屬「行政院衛生署管制藥品管理局」之權責事項,自一百 零二年七月二十三日起改由「衛生福利部食品藥物管理署」管轄 2.中華民國一百零三年十月二十三日衛生福利部部授食字第 1031203336 號令修正發布第 9 條條文 3.中華民國一百零九年二月二十一日衛生福利部衛授食字第 1081190495 號令、國防部國規委會字第 1080000338 號令會銜修正發布第 4 條條 文之附表
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These Regulations are made in exercising the powers conferred by Paragraph 3 of Article 23 of The National Defense Mobilisation Preparation Regulations (hereinafter referred to as “the Regulations”).
The term “medicines and medical devices” means essential medicines and medical devices for external use as indicated in Paragraphs 1 and 2 of Article 23 of the Regulations.
1The term “public and private hospitals” means –
21. the emergency responsible hospitals designated by the municipal, county or city government health authorities as in accordance with the Emergency Medical Services Act;
32. Armed Forces Hospitals;
43. other hospitals as appointed by the municipal, county or city government health authorities when necessary.
1Public and private hospitals shall make a reservation of medicines and medical devices as required under these Regulations.
2The Annexes include lists of items and quantities of the reserve medicines and medical devices as mentioned in the preceding paragraph.
Medicines and medical devices reserved by public and private hospitals shall be properly controlled and maintained of its items and quantities in order to comply with the requirements. Shall the expiration dates of the reserved items fall below 3 months, the stock should be renewed.
Medicines and medical devices reserved by public and private hospitals shall be stored separately according to their proper storage conditions in order to maintain the quality. In relation to any need arising for mobilisation, the reservoir shall be supplied within 2 hours.
Medicines and medical devices reserved by public and private hospitals shall, in relation to any needs arising for mobilisation, be under the control and schedule of their use by the competent health authorities.
1Municipal, county or city government health authorities shall provide counseling services to public and private hospitals within their jurisdiction annually, with regular checks on their reserve medicines and medical devices.
2For the control and schedule of use, and the counseling with regular checks on reserve medicines and medical devices as prescribed in the preceding article and paragraph, the activities to be carried out in armed forces hospitals shall be performed by the Medical Affairs Bureau of the Ministry of National Defense.
Schedule 1 and 2 controlled drugs shall be reserved by the Food and Drug Administration of the Ministry of Health and Welfare, in case of any need arising for mobilisation, as to provide public and private hospitals with sufficient stock.
These Regulations shall come into force on the date of promulgation.