Pharmaceutical Affairs Law (Republic of China)
Encyclopedia
The Pharmaceutical Affairs Law (PAL) of the Republic of China
(Taiwan
) is a
law regulating the manufacturing, importation, and sale of drugs and medical devices.
Article 103 of the February 1993 version of the law removed herbalist
s' rights to dispense drugs. In 1996, legislators from various parties are believed to have taken bribes from the National Union Chinese Medicine Association (中華民國中藥商業同業公會聯合會) in exchange for their support of an amendment reversing the February 1993 changes. The eight legislators in question were indicted in January 2008. Among them, Jao Yung-ching (DPP
) was simultaneously indicted in another bribery case regarding a 2003 amendment to the Oral Healthcare Act. Of the eight legislators in question, Chiu Chuei-chen (DPP) and Liao Hwu-peng (KMT
) were found guilty in a lower court trial, while the remainder were found not guilty. However, the High Court reversed the lower court ruling in September 2010; Lin Kwang-hua and Jao Yung-ching (both DPP) received eight-year sentences, Feng Ting-kuo (PFP) got seven years and two months, while Cheng Horng-chi (KMT) was sentenced to seven years.
, usage instructions, and a list of side effect
s. Such items are not limited to ingested medicines, but include other items such as condom
s and face masks. The Department of Health
is tasked with inspections to ensure compliance with the law; private organisations such as the Consumers' Foundation have also been known to carry out clandestine checks. A February 2007 check of sex shop
s found that 18 out of 25 condom brands did not label their ingredients clearly or at all, while 22 gave an incorrect authorisation number or none at all. A 2009 survey, also by the Consumers' Foundation, looked at 41 face masks (17 N95 masks and 24 surgical mask
s), and found that 90% did not meet the labelling and packaging requirements.
Sellers of drugs and medical devices are required by article 27 of the PAL to obtain a license from the Ministry of Health. Furthermore, article 37 requires that sales of all drugs, though not of medical devices, be carried out by a licensed pharmacist (or assistant pharmacist, in the case of non-narcotic
drugs). Not just pharmacies, but various other types of stores including convenience store
s and supermarket
s, have been able to obtain the required licenses. However, many small online sellers bring covered items back from overseas and sell them on internet auction websites without knowing about this requirement. Under articles 27 and 92, fines could range from NT$30,000 to $150,000. Items covered under the law include not just those which consumers traditionally think of as pharmaceuticals, but some unexpected items such as make-up, tooth bleaching
agents, hair removal
products, band-aids, knee pad
s, and body fat percentage
monitors.
Republic of China
The Republic of China , commonly known as Taiwan , is a unitary sovereign state located in East Asia. Originally based in mainland China, the Republic of China currently governs the island of Taiwan , which forms over 99% of its current territory, as well as Penghu, Kinmen, Matsu and other minor...
(Taiwan
Taiwan
Taiwan , also known, especially in the past, as Formosa , is the largest island of the same-named island group of East Asia in the western Pacific Ocean and located off the southeastern coast of mainland China. The island forms over 99% of the current territory of the Republic of China following...
) is a
law regulating the manufacturing, importation, and sale of drugs and medical devices.
Legislative history
The law was first publicised on 17 August 1970 as the Pharmaceutical and Drug Manufacturer Administration Law, with 90 articles. Thereafter it was amended eleven times (listed by date of publication):- 4 April 1979: amended Articles 24 to 27 and 54
- 5 February 1993: Act #0476 changed the name of the law to its present name and amended the whole text, with a new total of 106 articles.
- 8 March 1993: Act #0539 amended articles 38 and 61
- 7 May 1997: Act #8600104890 amended articles 53 and 106. Executive Yuan Order #075680-3 on 25 December 2001 established regulations as directed under article 53, bringing it into effect from 1 January 2002.
- 24 June 1998: Act #8700122830 amended article 103
- 26 April 2000: Act #8900105220 amended articles 2, 3, 27, 66, 77 to 79, 100, and 102
- 6 February 2003: Act #09200017750 amended article 39 and added subarticles 48-1 and 96-1
- 21 April 2004: Act #09300074821:
- amended articles 1, 8 9, 11, 13, 16, 22, 33, 37, 40 to 42, 45, 47, 48, 57, 62, 64, 66, 74 to 78, 82, 83, 91 to 93, 95, 96
- added sub-articles 27-1, 40-1, 45-1, 57-1, 66-1, 97-1, 99-1, 104-1, 104-2
- deleted articles 61 and 63
- 5 February 2005: Act #09400017691 amended sub-article 40-1 and added sub-article 40-2
- 17 May 2006: Act #09500069811 amended articles 66, 91, 92, 95, and 99, and deleted article 98
- 30 May 2006: Act #09500075771 amended articles 82, 83, and 106 with effect from 1 July 2006
Article 103 of the February 1993 version of the law removed herbalist
Herbalist
An herbalist is:#A person whose life is dedicated to the economic or medicinal uses of plants.#One skilled in the harvesting and collection of medicinal plants ....
s' rights to dispense drugs. In 1996, legislators from various parties are believed to have taken bribes from the National Union Chinese Medicine Association (中華民國中藥商業同業公會聯合會) in exchange for their support of an amendment reversing the February 1993 changes. The eight legislators in question were indicted in January 2008. Among them, Jao Yung-ching (DPP
Democratic Progressive Party
The Democratic Progressive Party is a political party in Taiwan, and the dominant party in the Pan-Green Coalition. Founded in 1986, DPP is the first meaningful opposition party in Taiwan. It has traditionally been associated with strong advocacy of human rights and a distinct Taiwanese identity,...
) was simultaneously indicted in another bribery case regarding a 2003 amendment to the Oral Healthcare Act. Of the eight legislators in question, Chiu Chuei-chen (DPP) and Liao Hwu-peng (KMT
Kuomintang
The Kuomintang of China , sometimes romanized as Guomindang via the Pinyin transcription system or GMD for short, and translated as the Chinese Nationalist Party is a founding and ruling political party of the Republic of China . Its guiding ideology is the Three Principles of the People, espoused...
) were found guilty in a lower court trial, while the remainder were found not guilty. However, the High Court reversed the lower court ruling in September 2010; Lin Kwang-hua and Jao Yung-ching (both DPP) received eight-year sentences, Feng Ting-kuo (PFP) got seven years and two months, while Cheng Horng-chi (KMT) was sentenced to seven years.
Effects
The PAL establishes labelling requirements for all items under its purview, requiring them to display an authorisation number, expiration dateShelf life
Shelf life is the length of time that food, drink, medicine, chemicals, and many other perishable items are given before they are considered unsuitable for sale, use, or consumption...
, usage instructions, and a list of side effect
Side effect
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequences of the use of a drug.Occasionally, drugs are...
s. Such items are not limited to ingested medicines, but include other items such as condom
Condom
A condom is a barrier device most commonly used during sexual intercourse to reduce the probability of pregnancy and spreading sexually transmitted diseases . It is put on a man's erect penis and physically blocks ejaculated semen from entering the body of a sexual partner...
s and face masks. The Department of Health
Department of Health (Republic of China)
Department of Health of the Republic of China is an executive agency of the Executive Yuan responsible for the administration of the public health system, affordable and universal health care, hospitals, pharmaceutical, immunisation programmes, disease prevention, supervision and coordination of...
is tasked with inspections to ensure compliance with the law; private organisations such as the Consumers' Foundation have also been known to carry out clandestine checks. A February 2007 check of sex shop
Sex shop
A sex shop, erotic shop is a shop that sells products related to adult sexual or erotic entertainment, such as sex toys, lingerie, clothing, pornography, and other related products...
s found that 18 out of 25 condom brands did not label their ingredients clearly or at all, while 22 gave an incorrect authorisation number or none at all. A 2009 survey, also by the Consumers' Foundation, looked at 41 face masks (17 N95 masks and 24 surgical mask
Surgical mask
A surgical mask also known as a procedure mask is intended to be worn by health professionals during surgery and at other times to catch the bacteria shed in liquid droplets and aerosols from the wearer's mouth and nose....
s), and found that 90% did not meet the labelling and packaging requirements.
Sellers of drugs and medical devices are required by article 27 of the PAL to obtain a license from the Ministry of Health. Furthermore, article 37 requires that sales of all drugs, though not of medical devices, be carried out by a licensed pharmacist (or assistant pharmacist, in the case of non-narcotic
Narcotic
The term narcotic originally referred medically to any psychoactive compound with any sleep-inducing properties. In the United States of America it has since become associated with opioids, commonly morphine and heroin and their derivatives, such as hydrocodone. The term is, today, imprecisely...
drugs). Not just pharmacies, but various other types of stores including convenience store
Convenience store
A convenience store, corner store, corner shop, commonly called a bodega in Spanish-speaking areas of the United States, is a small store or shop in a built up area that stocks a range of everyday items such as groceries, toiletries, alcoholic and soft drinks, and may also offer money order and...
s and supermarket
Supermarket
A supermarket, a form of grocery store, is a self-service store offering a wide variety of food and household merchandise, organized into departments...
s, have been able to obtain the required licenses. However, many small online sellers bring covered items back from overseas and sell them on internet auction websites without knowing about this requirement. Under articles 27 and 92, fines could range from NT$30,000 to $150,000. Items covered under the law include not just those which consumers traditionally think of as pharmaceuticals, but some unexpected items such as make-up, tooth bleaching
Tooth bleaching
Dental bleaching, also known as tooth whitening, is a common procedure in general dentistry but most especially in the field of cosmetic dentistry. A child's deciduous teeth are generally whiter than the adult teeth that follow. As a person ages the adult teeth often become darker due to changes in...
agents, hair removal
Hair removal
Hair removal is the removal of body hair, and describes the methods used to achieve that result.Hair typically grows all over the human body during and after puberty. Men tend to have more body hair than women. Both men and women tend to have hair on the head, eyebrows, eyelashes, armpits, pubic...
products, band-aids, knee pad
Knee pad
Kneepads or knee pads are protective gear worn on knees to protect them against impact injury during , e.g., a fall or a strike, or to provide padding for extended kneeling.-In sports:...
s, and body fat percentage
Body fat percentage
A person's body mass percentage is the total weight of the person's fat divided by the person's weight and consists of essential body fat and storage body fat. Essential body fat is necessary to maintain life and reproductive functions. The percentage of essential body fat for women is greater than...
monitors.
External links
- English translation of the law from the Republic of China's Department of Health (current as of July 2005)