Decision giving consent for use (Article 110, paragraph 2)
In cases of emergency, the minister of Agriculture, Fisheries, Food Security and Nature (Dutch LVVN) may take a decision giving consent for the use of an unauthorised veterinary medicinal product.
A decision giving consent for use is issued pursuant to Article 110, paragraph 2 of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).
Assessment of a decision giving consent for use
A decision giving consent for use is not a marketing authorisation. Such decision may only be taken in cases of emergency. That is why fewer requirements apply.
A decision under Article 110, paragraph 2 can only be taken for immunological veterinary medicinal products (such as vaccines). It only applies for a listed disease as referred to in Article 5 of Regulation (EU) 2016/429 or an emerging disease as referred to in Article 6 of that Regulation.
In the case of a decision giving consent for use, the data are assessed for the most critical points of quality, safety and efficacy. This assessment is carried out by the Veterinary Medicinal Products Unit, after which the Committee for the Authorisation of Veterinary Medicines (Ctd) advises the Minister of LVVN. This allows for a veterinary medicinal product to become available as soon as possible if there is an emergency.
Duration of a decision giving consent for use
A decision giving consent for use does not apply for an indefinite period of time. The end date of the consent can be found in the decision giving consent for use. The minister of LVVN, who decides on this period, has decided that the standard period is 90 days after a comparable veterinary medicinal product received a marketing authorisation.
Transitional situation after issue of a marketing authorisation
At the time a vaccine against the same disease has received official authorisation (in other words: a marketing authorisation), the requirements as set out in the summary of the product characteristics (SPC) of the authorised veterinary medicinal product will apply. In addition, all requirements set in the Veterinary Medicinal Products Regulation to veterinary medicinal products with a marketing authorisation apply.
It may well be that these requirements differ from the requirements as listed in the previous decision giving consent for use, so you should read the package leaflet carefully to ensure correct use of the product.
During a period of 90 days after the vaccine or another vaccine against the same disease received a marketing authorisation, you are allowed to use the vaccines already authorised under Article 110, paragraph 2 in accordance with the old SPC. After that period, you are no longer allowed to use the product authorised under Article 110, paragraph 2.