Clipping Board » Medical Affairs and Administration ─ Medical system, pharmaceuticals, and medical community-related reports
Update Date: 2010/06/19 04:11 [Reporters Chen Jingmin, Wei Yijia / Taipei Report]
A 32-year-old woman surnamed Hong, after giving birth to her second child, posted a message on the well-known parenting website Baby Home, offering to "exchange" an infrared thermometer and a postpartum belly binder for infant formula for babies under one year old. Last week, the Taipei City Department of Health summoned her for questioning, stating that her actions allegedly violated Article 27 of the Pharmaceutical Affairs Act, which prohibits "non-pharmaceutical businesses from engaging in commercial activities." She may face a fine of NT$30,000 to NT$150,000 under Article 92, leaving Hong stunned.
**Responding to Other Parents' Experiences May Also Break the Law**
Hong mentioned that another young mother had kindly responded to a netizen's inquiry by sharing her experience using a certain maternal and child product and mentioning where it could be purchased. She was then reported for allegedly promoting pharmaceuticals, violating Article 65 of the Pharmaceutical Affairs Act, which states that "non-pharmaceutical businesses may not advertise drugs." She now faces a potential fine of NT$200,000 to NT$5 million under Article 91.
Netizens have reported that at least 1,000 people nationwide, primarily in Taipei City, Taoyuan County, and Kaohsiung County, are caught in this legal storm. They are now mobilizing to petition relevant authorities, hoping that "while cracking down on big offenders, small ones may be spared."
Yesterday, accompanied by Taipei City Councilor Chen Jianming, Hong spoke out, questioning the government's encouragement for citizens to have more children and its advocacy for resource conservation and maximizing utility, while simultaneously "targeting young mothers with contradictory and questionable practices." She suspects the case involves professional whistleblowers using entrapment tactics to lure people into breaking the law. She emphasized that she was not profiting and would not accept any penalty imposed on her.
**Health Authorities: Warnings Issued Upon Receiving Reports**
Shen Meili, a technical specialist at the Taipei City Department of Health's Drug and Food Management Division, explained that current regulations explicitly prohibit non-pharmaceutical businesses from selling or advertising drugs and medical devices. This year, the department has received 1,507 reported cases, of which three involved serious violations, each fined NT$30,000. Most others were deemed cases of ignorance or minor infractions, resulting in warnings and requests to remove the posted information. "In principle, first-time offenders are not heavily penalized."
Lin Xinhui, a section chief at the Department of Medical Devices and Cosmetics under the Department of Health, pointed out that sharing personal experiences online without involving sales or exchanges does not violate the law. If recommendations are made, personal endorsements are generally treated leniently without penalties. However, if the behavior constitutes advertising by a manufacturer, pharmaceutical advertisements must undergo prior review. Violations of advertising regulations will be severely penalized.
Chen Jianming stated that many items officially classified as drugs or medical devices are common household products. For example, someone selling three cotton swabs online was fined NT$30,000. He argued that the law should be amended.
Lin Xinhui noted that medical devices are categorized into three levels based on their invasiveness and potential risk to the human body: Class I (low risk), Class II (moderate risk), and Class III (high risk). Class I medical devices include cotton swabs and medical masks. However, some cotton swabs and masks are not certified as medical devices and thus are not subject to regulation when sold.
Regarding whether low-risk medical devices should be allowed for online sales, Lin Xinhui said further expert discussion and evaluation are needed. Moreover, any changes would require amendments to the Pharmaceutical Affairs Act, which cannot be altered easily.
**Background Information**
**Medical Devices Require Licenses for Sale**
Drugs or medical devices must undergo review and registration by the Department of Health before being marketed, and a license number must be issued. Manufacturers must include this number on the product packaging, such as "衛署藥製 (輸) 123456," indicating that the drug is approved by the Department of Health for domestic production (or import) with license number 123456. Medical devices are labeled as "衛署醫器製 (輸) 987654."Cotton swabs, band-aids, masks, artificial tears, condoms, pregnancy test strips, Viagra, hair growth solutions, eye drops, smoking cessation inhalers, mosquito repellent patches, ginseng and angelica, Siwu drink, glucosamine, Chujo-to, Biofermin, multivitamins, blood pressure monitors, ear (forehead) thermometers, nasal aspirators, electrotherapy devices, blood lancets, infrared health lamps, wheelchairs, crutches, abdominal binders, and other items certified as medical devices are considered pharmaceuticals or medical equipment.
Pharmaceuticals or medical equipment can only be sold with a medical device sales business license. Online shopping and auction platforms not only lack such licenses but also cannot provide in-person product inspection or professional usage instructions, making their sale prohibited. (Reporters: Chen Jingmin, Wei Yijia)
Source: http:/ / tw. news. yahoo. com/ art……url/ d/ a/ 100619/ 78/ 27qek. html
Violating Pharmaceutical Law: Online Trading of Thermometers and Belts Risks Penalties
A 32-year-old woman surnamed Hong, after giving birth to her second child, posted a message on the well-known parenting website Baby Home, offering to "exchange" an infrared thermometer and a postpartum belly binder for infant formula for babies under one year old. Last week, the Taipei City Department of Health summoned her for questioning, stating that her actions allegedly violated Article 27 of the Pharmaceutical Affairs Act, which prohibits "non-pharmaceutical businesses from engaging in commercial activities." She may face a fine of NT$30,000 to NT$150,000 under Article 92, leaving Hong stunned.
**Responding to Other Parents' Experiences May Also Break the Law**
Hong mentioned that another young mother had kindly responded to a netizen's inquiry by sharing her experience using a certain maternal and child product and mentioning where it could be purchased. She was then reported for allegedly promoting pharmaceuticals, violating Article 65 of the Pharmaceutical Affairs Act, which states that "non-pharmaceutical businesses may not advertise drugs." She now faces a potential fine of NT$200,000 to NT$5 million under Article 91.
Netizens have reported that at least 1,000 people nationwide, primarily in Taipei City, Taoyuan County, and Kaohsiung County, are caught in this legal storm. They are now mobilizing to petition relevant authorities, hoping that "while cracking down on big offenders, small ones may be spared."
Yesterday, accompanied by Taipei City Councilor Chen Jianming, Hong spoke out, questioning the government's encouragement for citizens to have more children and its advocacy for resource conservation and maximizing utility, while simultaneously "targeting young mothers with contradictory and questionable practices." She suspects the case involves professional whistleblowers using entrapment tactics to lure people into breaking the law. She emphasized that she was not profiting and would not accept any penalty imposed on her.
**Health Authorities: Warnings Issued Upon Receiving Reports**
Shen Meili, a technical specialist at the Taipei City Department of Health's Drug and Food Management Division, explained that current regulations explicitly prohibit non-pharmaceutical businesses from selling or advertising drugs and medical devices. This year, the department has received 1,507 reported cases, of which three involved serious violations, each fined NT$30,000. Most others were deemed cases of ignorance or minor infractions, resulting in warnings and requests to remove the posted information. "In principle, first-time offenders are not heavily penalized."
Lin Xinhui, a section chief at the Department of Medical Devices and Cosmetics under the Department of Health, pointed out that sharing personal experiences online without involving sales or exchanges does not violate the law. If recommendations are made, personal endorsements are generally treated leniently without penalties. However, if the behavior constitutes advertising by a manufacturer, pharmaceutical advertisements must undergo prior review. Violations of advertising regulations will be severely penalized.
Chen Jianming stated that many items officially classified as drugs or medical devices are common household products. For example, someone selling three cotton swabs online was fined NT$30,000. He argued that the law should be amended.
Lin Xinhui noted that medical devices are categorized into three levels based on their invasiveness and potential risk to the human body: Class I (low risk), Class II (moderate risk), and Class III (high risk). Class I medical devices include cotton swabs and medical masks. However, some cotton swabs and masks are not certified as medical devices and thus are not subject to regulation when sold.
Regarding whether low-risk medical devices should be allowed for online sales, Lin Xinhui said further expert discussion and evaluation are needed. Moreover, any changes would require amendments to the Pharmaceutical Affairs Act, which cannot be altered easily.
**Background Information**
**Medical Devices Require Licenses for Sale**
Drugs or medical devices must undergo review and registration by the Department of Health before being marketed, and a license number must be issued. Manufacturers must include this number on the product packaging, such as "衛署藥製 (輸) 123456," indicating that the drug is approved by the Department of Health for domestic production (or import) with license number 123456. Medical devices are labeled as "衛署醫器製 (輸) 987654."Cotton swabs, band-aids, masks, artificial tears, condoms, pregnancy test strips, Viagra, hair growth solutions, eye drops, smoking cessation inhalers, mosquito repellent patches, ginseng and angelica, Siwu drink, glucosamine, Chujo-to, Biofermin, multivitamins, blood pressure monitors, ear (forehead) thermometers, nasal aspirators, electrotherapy devices, blood lancets, infrared health lamps, wheelchairs, crutches, abdominal binders, and other items certified as medical devices are considered pharmaceuticals or medical equipment.
Pharmaceuticals or medical equipment can only be sold with a medical device sales business license. Online shopping and auction platforms not only lack such licenses but also cannot provide in-person product inspection or professional usage instructions, making their sale prohibited. (Reporters: Chen Jingmin, Wei Yijia)
Source: http:/ / tw. news. yahoo. com/ art……url/ d/ a/ 100619/ 78/ 27qek. html