Article 362 of the Criminal Code

What Article 362 of the Criminal Code punishes

Article 362 punishes the falsification of medicines and medical devices, among the offences against public health. It applies to anyone who manufactures or produces a medicine —including for human and veterinary use, and investigational medicines—, an active substance or excipient, or a medical device and its essential accessories, presenting it in a misleading way as to its identity (packaging, labelling, expiry date, composition, dosage), its origin (manufacturer, country of origin, marketing-authorisation holder), compliance with legal requirements or licences, or its distribution history, provided it was intended for public consumption or use by others and creates a risk to life or health. The same penalty applies to anyone who alters the quantity, dose, expiry date or genuine composition of those products in a way that reduces their safety, efficacy or quality and creates that risk.

This is an offence of concrete danger: it does not require the counterfeit medicine to actually cause real harm to someone's health, only that its misleading presentation creates a real risk to the life or health of those who might consume or use it.

Penalty

The penalty is six months to four years in prison, a fine of six to eighteen months, and special disqualification from a profession or trade for one to three years.

Common scenarios

This offence arises in the clandestine manufacture of counterfeit medicines —with active ingredients in the wrong dose, missing altogether, or entirely different from those declared— later sold as genuine products, often through unauthorised online sales channels or illegal pharmacies; in falsifying medical devices such as diagnostic tests, certified face masks or medical equipment, presenting them with non-existent quality or conformity certifications; and in altering expiry dates or batch numbers on genuine medicines to keep selling them after they have expired.

Defense strategy

The defense should focus on a pharmacological expert analysis of the seized product, to determine whether its actual composition truly created a health risk or whether, despite the administrative irregularity, the product was harmless from a health standpoint, which can remove the element of risk the offence requires. It is also important to distinguish between wilful falsification of the product's origin or composition and the mere marketing of genuine medicines outside authorised channels, which may amount to a separate, less serious administrative infringement. Finally, it is worth reviewing the product's actual intended use: if it was not truly intended for public consumption or use by others, the offence is not completed.