These Regulations are promulgated pursuant to Article 45-1 of the Pharmaceutical Affairs Act (hereafter the Act).
The term "medicaments" as used in these Regulations shall refer to medicaments specified in Article 4 of the Act.
In the event that a medicament causes a severe adverse reaction, the medical care institution, pharmacy, and pharmaceutical firm shall fill out a notification along with relevant information and report to the central competent health authority or its commissioned institution in accordance with these Regulations.
The term "severe adverse reaction of medicament" as used in these Regulations shall refer to the use of a medicament resulting in occurrence of one of the conditions listed in the following subparagraphs:
2. Life-threatening condition;
3. Permanent disability;
4. Congenital anomaly/birth defect of fetus/infant;
5. Inpatient hospitalization or prolongation of existing hospitalization;
6. Others that may result in permanent injuries requiring intervention.
Within 7 days from the day of becoming aware of a severe adverse reaction of medicament in Subparagraphs 1 and 2 of the preceding Article, the medical care institution and pharmacy shall undertake reporting in accordance with Article 3 and notify with a copy to the pharmaceutical firm holding the medicament permit license.
In the event that information in the preceding Paragraph is not sufficiently provided, it shall be fully provided within 15 days.
In the event that reporting mentioned in the first Paragraph requires the pharmaceutical firm holding the medicament permit license to provide product relevant information, the pharmaceutical firm shall not refuse such a request.
Within 15 days from the day of becoming aware of a severe adverse reaction of medicament, the pharmaceutical firm holding the medicament permit license shall undertake reporting in accordance with Article 3.
When undertaking reporting in accordance with these Regulations, medical care institutions, pharmacies, and pharmaceutical firms may do so through postal mail, facsimile, or the Internet.
In the case of emergencies, reporting of the preceding Paragraph may first be done orally, and written reporting shall be completed within the time limit.
The competent central health authority and its commissioned institution may, when necessary, request that medical care institutions, pharmacies, and pharmaceutical firms provide medical records, medication administration records, or product information for patients with severe adverse reactions of medicaments. Medical care institutions, pharmacies, and pharmaceutical firms shall not refuse such requests.
These Regulations take effect from the date of promulgation.