: International drug labeling guidelines Are there any international guidelines regarding the labeling of drugs and pharmaceuticals?

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Generally, legislation of each country prescribes how medicines should be labeled. There are international guidelines, but national regulations always come first.

An example of international guidelines on labeling are the ones by World Health Organisation (WHO) given in Guidelines on packaging for pharmaceutical
products; WHO Technical Report Series, No. 902, 2002 which state that the label should contain at least:

(a) The name of the drug product;

(b) a list of the active ingredients (if applicable, with the International Nonproprietary Names), showing the amount of each
present, and a statement of the net contents, e.g. number of
dosage units, weight or volume;

(c) the batch number assigned by the manufacturer;

(d) the expiry date in an uncoded form;

(e) any special storage conditions or handling precautions that
may
be necessary;

(f) directions for use, and warnings and precautions that may be
necessary; and

(g) the name and address of the manufacturer or the company or the
person responsible for placing the product on the market.

Other example of international guidelines are those by European Medicines Agency in Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the Union which is binding for the member states.