Falsified Medicines Directive (FMD)

The FMD applies to the marketing of medical products for human use that are intended to be placed on the European market. These products must have been prepared industrially or manufactured by a method involving an industrial process.

The term ‘medical product’ is defined by the FMD as any substance or combination of substances presented as having properties for treating or preventing human diseases. Substances or combinations of substances used in or administered to human beings to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis are also considered as a ‘medical product’.

The FMD does not apply to magistral formulas (i.e., medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient).

The FMD imposes the labeling of certain information on the packaging of medicinal products or on the immediate packaging itself. This information includes (but is not limited to) the following elements:

• The name of the medicinal product, which must also be marked in Braille format on the product’s packaging.
• The pharmaceutical form and the contents by weight, by volume or by number of doses of the medicinal product.
• The method and route of administration.
• The expiry date of the product.
• The manufacturer's batch number.
• If the product can be purchased without a medical prescription, instructions for use.

The information must be provided in an easily legible, clearly comprehensible and indelible way.

Manufacturers and sellers of medicinal products as defined in the FMD must ensure that their products are properly labeled. Many labeling system providers offer labeling machines that ensure FMD-compliant labeling. These range from label dispensers to drop-on-demand inkjet printers.