Is pharmaceutical labeling regulated differently in different countries?

When it comes to labeling drugs, the industry is heavily regulated to ensure the safety of users. With every country having its economy and governing bodies, the regulations are likely to see some variations overseas depending on the market a new product is being sold.

The exporting of drugs is an area that is handled differently in different nations, with thorough processes often being required to ensure an importation meets local regulations. Certificates of origin are requested by foreign trading partners when pharmaceutical companies export their drugs which proves their eligibility and shows that the product meets the criteria set by the arrival country. Customs are in a position to penalize a company that fails to accurately disclose the contents of its products and if drugs are incorrectly labeled, the suppliers are subject to high penalties and can face severe legal issues.

In the U.S., customs law requires all entering drugs to be marked with their COO if not U.S. made as certain components may not be permitted, even if they are commonplace in the country of origin. To maintain a supply chain flow, pharmaceutical companies trading overseas must be aware of overseas regulations and reflect this in the labeling, packaging, and any promotional material created. For example, if a product is being designed for sale in the U.S., they are forbidden by law to be marked “Made in the USA” unless they are entirely produced in the U.S., even if the majority was done so.

Another key difference in pharmaceutical labeling across different countries is the way drugs are labeled. According to the FDA, a drug label must state the manufacturer’s place of business, but the manufacturer may be considered differently in a different nation. In this case, it is stated as the provider who performs mixing, granulating, milling, molding, lyophilizing, tableting, encapsulating, coating, sterilizing, or filling, only being considered a U.S. manufacturer if completely carried out in the home country. If this is miscommunicated on labeling, it will be denied entry as it is classified as false or misleading.


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