Packaging and regulations of the hottest drugs

2022-07-31
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With the sustained and healthy economic development, China has become one of the top ten pharmaceutical producing countries and raw material exporting countries in the world. However, at present, the overall level of drug packaging in China still lags behind that in developed countries. In addition to technical and management reasons, a very important point is that the legal environment of packaging mdash includes many aspects, such as legislation, justice and legal awareness

the legal issues involved in drug packaging are quite extensive. It involves not only domestic laws, but also extraterritorial laws and international standards. This paper discusses the relationship between trademark right, patent right, copyright, anti unfair competition, consumer protection, environmental protection, product quality standards and drug packaging

drug packaging and trademark

trademark is a visual sign that distinguishes each other's goods. Its constituent elements can include words, graphics, numbers, letters, colors, three-dimensional signs and their combinations. Trademark registration can enable drugs to be more effectively protected by law, enhance their market competitiveness, help consumers identify and shop, correctly select safe and effective drugs, and support their confidence in drugs and manufacturers. In the trademark registration system, voluntary registration is the main method in China, but compulsory registration is given to human drugs and tobacco products. Because human drugs are related to people's life, health and safety. That is to say, drugs with unregistered trademarks will be regarded as fake drugs and counterfeit drugs when they enter the market. Drug trademarks mainly exist on drug packaging. The drug name, generic drug name and geographical indications shall not be used as trademarks. For example, Yunnan Baiyao and Liuwei Dihuang pills are geographical indications or generic names of drugs. In order to achieve the purpose of identifying or publicizing drugs, the drug trademark shall be highlighted on the drug package rather than the generic name of the drug. For example, Chinese medicine has the reputation of white medicine in the South and red medicine in the north. Shenyang traditional Chinese medicine factory produces Shenyang Hongyao, but the trademark is placed in a very inconspicuous position in the drug packaging, which is difficult to attract the eyes of consumers. Therefore, the market is impressed by Shenyang Hongyao, but is very unfamiliar with the trademark. Now they have to face up to the embarrassing situation that more than 20 manufacturers across the country counterfeit Shenyang red medicine but can do nothing about it. Wuji Baifeng pill is an ancient prescription of traditional Chinese medicine with many producers. However, Huiren Wuji Baifeng pill comes from behind and outshines others, that is, the manufacturer's legal concept and marketing concept are mature, and Huiren is highlighted in drug packaging and advertising

drug packaging and patents

drug production involves patented technology or technical secrets, but drug packaging mainly involves design protection. China is a member of the Paris Convention. The minimum requirement of the Paris Convention is to protect industrial designs. In the WTO, the agreement on trade related aspects of intellectual property rights (TRIPS) also stipulates in principle the protection of industrial designs. China's domestic law on design protection is mainly reflected in the patent law. The conditions for awarding the design are mainly novelty, practicality and beauty. The edible commodities for which design protection is applied in China mainly include food and alcohol products. However, the application for design protection of drug packaging is less, which may be related to the fact that people pay more attention to the efficacy of drugs. However, if the packaging of specialty drugs, high-grade drugs and drugs that can be given as gifts is not damaged, the design patent right should be ignored when it is connected with the collet

drug packaging and copyright protection

art works can become an integral part of drug packaging, so drug packaging may involve rights in the field of copyright. The author has not seen any cases of legal disputes in this regard. However, in 1980, Shandong Jingyanggang distillery used the 11th picture of Wusong beating the tiger created by painter liujiyou as its trademark pattern, wine bottle sticker and outer packaging decoration, and was awarded a compensation of 200000 yuan. Therefore, as a drug packaging designer, we should consider the legal status at the time of design: or copyright issues, or the complex legal relationship of overlapping trademarks, patents and copyrights

drug packaging and anti unfair competition

in drug packaging and drug advertising, unfair competition should be avoided. China's "Anti Unfair Competition Law" stipulates that the unauthorized use of the unique names, packaging and decoration of well-known commodities, the forgery or fraudulent use of certification marks, famous and high-quality marks, the use of false written descriptions, and the slandering of the goodwill of competitors constitute unfair competition, which must bear the corresponding legal responsibilities. In 1995, the giant company produced a product similar to Wahaha children's nutrition liquid mdash giant meal incense, and said in its product brochure: it is said that Wahaha has hormones, resulting in premature children and many modern children's diseases. The court found that it constituted unfair competition, and the giant was sentenced to pay 2million yuan

packaging design and protection of consumers' rights and interests

the consumer rights and interests protection law stipulates that any adulteration, adulteration, substandard goods as good, misleading consumers, or violation of the provisions of the product quality law shall be liable for legal liabilities. On april7,2003, the law enforcement officers of Hunan Provincial Institute of health supervision banned the Danlan brand fire reducing pueraria powder and Danlan brand fat reducing fern root powder sold in some supermarkets in Changsha. The former is clearly marked with fire reducing effect on the packaging box, but there is no formal approval on the packaging box or instruction manual to prove this function of the product. The latter claimed to have lipid-lowering function, but also failed to provide the approval of the health department for this function (see Sanxiang City daily, April 8, 2003). In the drugstore, the author saw a kind of sexual health care product that appeared frequently on TV recently. In the luxurious package of one foot square, only 40 small pills were embedded. Under the helpless introduction of the marketing personnel, the author had to shake his head and walk away

drug packaging and domestic regulations and international standards

China's drug administration law has set up a special chapter on drug packaging and sub packaging, which makes special provisions on drug packaging. Including: the name, specification, manufacturer, approval number, product batch number, main ingredients, indications, usage, dosage, contraindications, adverse reactions and precautions of the drug must be indicated on the label or instruction manual of the drug package. In 2000, the measures for the administration of materials and containers for drug packaging (Provisional) (order 21) and the regulations on the administration of drug packaging labels and instructions (order 23) also made detailed provisions on drug packaging. In march2003, the relevant law enforcement units in Hunan Province temporarily detained the gold of a well-known domestic health care drug from the cabinet because its drug packaging did not mark the relevant contents in accordance with the law

China's traditional Chinese medicine has a history of thousands of years, but it has failed to enter the European and American markets on a large scale. In addition to the old production process and some prejudice against traditional Chinese medicine in European and American countries, the failure of drug packaging to implement international standards is also an important reason. The packaging of traditional Chinese medicine for export must comply with the relevant laws and regulations of the importing countries and regions. For example, Singapore lists Coptis chinensis and Ligusticum chuanxiong as toxic substances, and the import of traditional Chinese medicine containing these ingredients is prohibited; For traditional Chinese medicine containing lead and aluminum, the content of lead must be less than 15ppm, and the content of aluminum must be less than 20ppm; The United States also prohibits the import and sale of traditional Chinese medicines containing heavy metals such as cinnabar, mercury and arsenic

it is understood that the health department of Canada has formulated a series of regulations such as the food and drug safety management act and the drug identification number management act to strengthen the management of Chinese herbal medicine and its products. It is stipulated that any product with the full digital 3 closed-loop control effect of therapeutic realization, deformation and displacement shall be treated as a drug. Products that do not meet the health standards shall not be allowed to go on the market. All Chinese herbal medicine products must apply for a drug license from Health Canada, that is, a drug identification number management license. In addition, the US Department of agriculture has recently made new regulations on the packaging of all imported products, including Chinese herbal medicine. All pure wood packaging materials must be subject to high-temperature fumigation or protective agent treatment. Otherwise, all incoming goods will be refused entry. France has stricter regulations on wood packaging, which stipulates that all imported products are not allowed to use wood packaging

the US FDA, that is, the US Food and drug administration, has formulated corresponding regulations for all links of drug sales, and stipulated that all drug-related materials should be subject to clinical scientific testing. The drug label must not only include the use of the drug, precautions for use by special groups (such as children, pregnant women, etc.), dose description, use method and time, but also indicate the side effects, contraindications and efficacy of the drug. Any label that does not meet the requirements of the regulations is recognized as a false label, which is a serious violation of federal law. In order to advertise drugs or provide relevant publicity materials, the contents must be exactly the same as those of the label, and there shall be no other materials that take polyurethane as an example and are not approved or used beyond the scope of the label. Obviously, the implementation of these regulations has had a certain impact on the sales of Chinese traditional medicine in the North American market

drug packaging and environmental protection

developing green packaging, protecting the environment and promoting the sustainable development of society are hot issues of global concern. After China's accession to the WTO, tariff barriers are gradually eliminated, but technical barriers and environmental barriers are gradually forming. In January1999, ISO's green environmental protection sign (EL) began to be implemented worldwide

now many countries in the world are restricting excessive packaging and issuing many corresponding laws and regulations. For example, the United Kingdom limits the complexity and luxury of commodity packaging in accordance with a certain proportion, and severely punishes those who exceed the standard. In order to encourage businesses to simplify packaging, in order to facilitate environmental protection. In China, a green packaging law should also be introduced, which should include the disposal of waste materials for drug packaging and data processing, and the safety of packaging materials for human health protection

market economy is legal economy. While carrying out the technical design of China's pharmaceutical packaging, we also pay attention to its unavoidable legal problems, and urge it to abide by the rules of the game. It will be beneficial to promote the healthy development of China's pharmaceutical packaging industry and even the pharmaceutical industry, and enhance its international competitiveness and its ability to resist risks

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