Legal issues involved in pharmaceutical packaging is quite extensive , involving not only domestic law , but also involves extraterritorial laws and international plastic packaging box standards. Text on trademarks, relations patents, copyrights , unfair competition and consumer protection , environmental protection, product quality standards , such as legal issues were discussed and pharmaceutical packaging .

Pharmaceutical packaging with international standards

China’s ” Drug Administration Law” established “drug packaging and repackaging ” special chapter on the issue of pharmaceutical packaging made ??special provisions . These include: pharmaceutical packaging must be marked on the label or instructions drug name, size, manufacturer, approval number, batch number, the main ingredients, indications, usage , dosage , contraindications , side effects and precautions. 2000 promulgated the ” drug packaging materials , container management practices ( Provisional ) ” ( 21 orders ) , “drug packaging labels and instructions regulations” ( 23 orders ) for pharmaceutical packaging also made detailed provisions. March 2003 , the law enforcement unit of packaging design Hunan had a famous health drugs ” gold” withheld under the counter , because the law fails to pharmaceutical packaging labeling the contents.

Chinese medicine in China several thousand years of history , has failed mass into the European market, in addition to the production process obsolete and European countries for a certain bias in medicine , the pharmaceutical packaging failed to perform well with clear plastic packaging international standards is also an important reason. Export of pharmaceutical packaging must comply with the relevant regulations of the importing countries and regions . Such as Singapore to berberine, plastic packaging design Chuanxiong as toxic , medicine containing these ingredients are banned the import ; of lead, aluminum, Chinese medicine , lead content must be less than 15ppm, the aluminum content of less than 20ppm; United States about cinnabar, mercury, Chinese arsenic and other heavy metals are also banned the import and sales.

It is understood that the Canadian Ministry of Health to strengthen the management of its herbal products , developed a ” Food and Drug Safety Administration Law ,” ” Drug Identification Number Management Law” and a series of laws and regulations. Require any therapeutic effect of drugs should be treated products , the product does not meet the health standards are not allowed to market, all herbal products must apply for a permit from the Health Canada Drug , Drug identification number that management licenses. In addition , the U.S. Department of Agriculture also recently imported , including herbal products plastic trays , including all packaging to make new regulations, all pure wood packaging material to go through fumigation or repellant treatment temperature , otherwise all goods shipped will be refused entry off. France on wood packaging regulations are more stringent , requiring all imported products are not allowed to use wood packaging.

U.S. fda, namely the United States Food and Drug Administration for all aspects of drug sales , have developed appropriate laws and regulations of all materials required by the drug-related clinical science test. Drug labels must include not plastic packaging only the use of drugs , special populations ( such as children , pregnant women , etc. ) Note the use of dosage instructions , using the method and time , but also to indicate the side effects of drugs , contraindications and efficacy of any non-compliance labeling requirements have been identified as “fake label” , is a serious violation of federal law. And do drugs -related advertisements or promotional materials provided , and label its contents must be identical, may not have any information other than the unauthorized use of or beyond the scope of the label . Clearly, the implementation of these regulations on the sale of traditional Chinese medicine in the vac tray North American market had a certain impact.

Becoming the new international standards of environmental protection

Development of green packaging , protecting the environment and promoting sustainable development of society , is today’s hot issues of global concern . After China joined the WTO, the gradual elimination of tariff barriers , but technical barriers, environmental barriers , but plastic box in an increasingly formed . January 1999 , iso green flag (el) introduced worldwide.

Now many countries are limiting excessive packaging and introduced many of the corresponding regulations. For example, the extent of the British luxury goods on the complexity of the package shall be restricted in accordance with a certain proportion of heavy penalties for those who exceed the standard . Thus prompting businesses to simplify packaging, in order to facilitate environmental protection. In our country , we should also introduce a ” Green clamshell packaging Packaging Act ” , which should include pharmaceutical packaging waste is handled , security packaging materials for the protection of human health and other specifications . Market economy that is the legal economy . At the same time, China’s pharmaceutical packaging technology design , but also concerned about their legal problems can not be circumvented , prompting its compliance with rules of the game , to promote the healthy development of China’s pharmaceutical packaging industry and even the pharmaceutical industry, and to enhance its international competitiveness and its own against risks capabilities are beneficial rather than harmful.

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