The labelling of the expiry date on certain veterinary packages to be allowed in the format dd/mm/yyyy

With the entry into force of Regulation (EU) 2019/6 on veterinary medicinal products on 28 January 2022, the product information (QRD) template was updated substantially. One of the changes is the indication of the expiry date on the outer and immediate package for veterinary medicinal products. The updated QRD template allows the expiry date to be expressed to the nearest day,i.e. in the format ‘dd/mm/yyyy’, on a case-by-case basis for biological and novel therapy veterinary medicinal products (e.g. for products whose shelf life is less than two years). According to Fimea’s Administrative Regulation 3/2019 ‘Labelling and package leaflets for medicinal products’, which is still in force, theexpiry date must be in the format ‘mm/yyyy’, which is based on the previous QRDtemplate guidelines when Directive 2001/82/EC on the Community code relating to veterinary medicinal products was in force. 

In applying Regulation (EU) 2019/6, the packages for veterinary medicinal products described above, where the expiry date has been approved for the format ‘dd/mm/yyyy’ with the variation application for updating the QRD template, do not therefore denote that the products are defective and no exemption needs to be applied for to bring these packages onto the market. It is Fimea’s view that indicating a more precise expiry date on the product types referred to is an exception permitted under Article 13 of Regulation (EU) 2019/6to the basic requirements stated under Article 10 of the Regulation, according to which the date must be expressed in the format ‘mm/yyyy.’

Fimea’s Administrative Regulations are to be updated regarding veterinary medicinal products, when the amendments to the Finnish Medicines Act being drafted by the Ministry of Social Affairs and Health have made sufficient progress.