Guidance, Law & Regulations
The Mobilisation of Reserve Medicines and Medical Devices Regulations
1.Promulgated on September 26, 2002
2.Amended on October 23, 2014
|These Regulations are made in exercising the powers conferred by Paragraph 3 of Article 23 ofThe 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.|
|The term “public and private hospitals” means –|
1. the emergency responsible hospitals designated by the municipal, county or city government health authorities asin accordance with the Emergency Medical Services Act;
2. Armed Forces Hospitals;
3. other hospitals as appointed by the municipal, county or city government health authorities when necessary.
|Public and private hospitals shall make a reservation of medicines and medical devices as requiredunder these Regulations.|
The Annexes include lists of items and quantities of the reserve medicines and medical devicesas 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 formobilisation, 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.|
|Municipal, 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.|
For 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|