Selling Health Products Abroad: Drug and Health Licences

Health products are among the most regulated goods in the world. A product can be a medicine or a medical device or a supplement or a cosmetic. Each group follows its own route and the line between them is not always obvious.

Work out your category first The same ingredient can be a medicine in one country and a supplement in another. The claims you make on the label often decide the category. Ask the regulator early so you do not prepare the wrong dossier.

A local licence holder Many countries require a licence holder or an authorised representative based locally. That person is responsible to the regulator for the product. Plan for this before you begin.

What the regulator looks at Expect to show the quality of manufacturing and the safety of the product and the evidence for what it does. Labels usually need to be in the local language. Approvals for medicines can take a long time so build that into your launch plan.

Tips Start with the regulator named on your country page. Keep your quality records and test data ready. If you sell supplements or cosmetics also check the ingredient rules because they differ by country.

These are general guides, not legal advice. Rules differ by country and by product and they change often. Confirm the details with the regulator named on your country page or with an expert before you act.