1. Anyone who manufactures or produces
a) a medicinal product, including those for human and veterinary use, as well as investigational medicinal products; or an active substance or an excipient of said medicinal product;
b) a medical device, as well as the accessories, elements or materials that are essential for its integrity;
in such a way that it is presented deceptively: its identity, including, where applicable, the packaging and labelling, the expiry date, the name or composition of any of its components, or, where applicable, the dosage thereof; its origin, including the manufacturer, the country of manufacture, the country of origin and the holder of the marketing authorization or the documents of conformity; data relating to compliance with legal requirements or demands, licenses, documents of conformity or authorizations; shall be punished with a prison sentence of six months to four years, a fine of six to eighteen months and special disqualification from a profession or trade of one to three years; or its history, including records and documents relating to the distribution channels used, provided that they were intended for public consumption or use by third parties, and pose a risk to the life or health of individuals.
2. The same penalties shall be imposed on anyone who alters, during manufacture or production or at a later time, the quantity, dosage, expiry date or genuine composition, as authorized or declared, of any of the medicines, substances, excipients, medical devices, accessories, elements or materials mentioned in the preceding paragraph, in a way that reduces their safety, efficacy or quality, thereby creating a risk to the life or health of individuals.