Immunological veterinary medicinal products
Ordinance amending the Medicinal Products Ordinance
The new provision in Chapter 8, Section 1 of the Medicinal Products Ordinance means that the Swedish Medical Products Agency may, in individual cases, decide to prohibit the manufacture, import, distribution, possession, sale or supply of immunological veterinary medicinal products if any of the conditions laid down in Article 110(1) of Regulation (EU) 2019/6 of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC are met. Such a decision may be subject to conditions.
The provision authorising the Swedish Medical Products Agency to prohibit the use of certain immunological veterinary medicinal products in individual cases is an introduction into Swedish law of the prohibition that Member States are allowed to have in their national law under Article 110(1). The formulation of the provision is based on Article 106(3) of Regulation (EU) 2019/6, which provides that Member States may lay down all the procedures they deem necessary for the implementation of, inter alia, Article 110.
In this context, it may be mentioned that the government also intends to introduce in an ordinance an authorisation whereby the Swedish Medical Products Agency may issue regulations prohibiting the above mentioned handling of immunological veterinary medicinal products if any of the conditions laid down in Article 110(1) of Regulation (EU) 2019/6 are met. If the Swedish Medical Products Agency intends to issue such regulations, they will be notified under Directive (EU) 2015/1535 in a separate process.