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

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    – Lucky
    Oct 20 '16 at 2:08

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.

  • 1
    Thanks a lot! Still seems problematic to me. If a European pharmacy labels a drug product according to the EU guidelines and sells it in another country, it should be fine. But if that product than enters a third party country, there seems to be no guarantee that the labeling is sufficient for that country. Oct 21 '16 at 15:32
  • @jack Labeling is usually done for each country the medicine should be marketed in. After all, the patients should be able to understand the label - if you label a medicine in, say, German and try to market it in France that would not be good. Regulatory agencies in each country actually have requirements for labeling before they issue a marketing authorisation.
    – Lucky
    Oct 21 '16 at 15:36
  • There are pharmacies who sell their medicine to cargo ships, so the medicine enters different countries on a regular basis. Some countries' authorities are very particular about drug labeling (Nigera seems to be a pain-in-the-ass on that for some reason). And because a pharmacy cannot know in which countries a client's cargo ship is going to travel, it is virtually impossible to meet every countries labeling standards. Oct 24 '16 at 16:37

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