Hungary to impose stricter rules against fake medicines

By Andrea Simándi, Bálint Halász


A stricter legislative regime will now apply those who manufacture, distribute or stockpile unauthorized medicinal or veterinary products. The amendment of Government Decree No 218/1999 (XII.28.) on offences was initiated by the Hungarian National Board Against Counterfeiting.

Under the old law, it was previously necessary to show that an individual had intent to put to market. In practice this requirement was very hard to prove, and it was almost impossible to bring a successful case against drug counterfeiters. The new amendment has removed this element of intent.

The offence as amended imposes a fine of up to HUF 100,000 (approx EUR 380) for any person who:

  • manufactures or distributes a medicine without authorization, deals with medicine withdrawn from the market or not authorized in Hungary or possesses such medicine in undue quality, or possesses a substance or preparation which is subject to prescription in Hungary in undue quality;

  • manufactures or places into circulation a medicine which does not comply with relevant legislation;

  • includes unapproved text or data on the primary or secondary packaging, label, leaflet or summary of products characteristics or does not include approved text;

  •  markets a product by referring to curative effect without authorization to do so; or

  • does not comply with provisions on pharmacies.

The statutory maximum fine has doubled with the passing of the amendment. The amendment has also imposed mandatory seizure of all goods with which one of the above offences is committed. As a result, Hungarian authorities are now able to deprive perpetrators of the illegal profits, whilst also preventing the release of unauthorized products thereby preventing the marketing of ineffectual or harmful products endangering the health of patients.

As mentioned above, fines and the mandatory seizure of goods will also apply to any person who possesses in ‘undue quantity’ a medicinal product that has not been authorized in Hungary or that is subject to prescription. The amendment defines ‘undue quantity’ as meaning a quantity exceeding the personal needs of a particular patient.

As part of the Hungarian anti-counterfeiting strategy, this amendment marks a major step in the fight against counterfeit products, especially fake medicinal products. The amendment also forms an important part of Hungary’s implementation of Directive 2001/83/EC as amended by Directive 2011/62/EU on the prevention of the entry into the legal supply chain of falsified medicinal products.