On 9 February 2019, the Delegated Regulation 2016/161 (Delegated Regulation), as part of the implementation measures by the Commission in the context of the Falsified Medicine Directive (2011/62/EU) entered into force.
The rationale behind the Falsified Medicines Directive is to improve the safety and security of original medicines in the European Union (see also Synapse on Falsified Medicines Directive here). For example, the Falsified Medicines Directive introduces the obligation for online pharmacies/retailers to use a particular logo on websites and specifies rules on imports of pharmaceuticals.
The new Delegated Regulation lays down detailed rules for a new medicine verification system appearing on the packaging of medicinal products for human use. In other words, this new regulation requires manufacturers to add a safety feature which consists of an anti-tampering device and a unique identifier on the outer packaging of medicinal products.
The unique identifier is a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product and is encoded in a 2D barcode. The Delegated Regulation sets out several required data elements for this unique identifier.
The unique identifier is a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product and is encoded in a 2D barcode. The Delegated Regulation sets out several required data elements for this unique identifier.
Implications (in the Netherlands)
The Delegated Regulation does not provide for any financial compensation to manufacturers for applying the new safety features. In the Netherlands, this has raised concerns among generic and biosimilar medicines producers. In contrast to the Association Innovative Medicines, which confirmed to the Dutch regulator that these financial costs for the safety features could be compensated in the market price, the Dutch Generic and Biosimilar Medicines Association stated that the extra costs would have the effect that they would not make a reasonable profit on their products.
Therefore, the Dutch Minister of Health, Welfare and Sport decided that the legally permitted maximum price could be temporarily raised upon request of the manufacturer. Manufacturers were given until December last year to file such requests. Several manufacturers have made use of this possibility.
