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Product authorisation

A company wishing to place disinfectants or teat disinfection products on the market must submit an application to the DVFA before the product can be placed on the market.

​​​​​​The Danish Veterinary and Food Administration approves these products after assessing whether they are proven to be effective in eliminating microorganisms at the recommended concentration. The authorisation is also based on the fact that when properly used, there is no human health risk from residues. Only products which do not pose a health risk are approved.

The DVFA does not approve disinfectants and teat disinfection products containing certain type of dyes. If colouring is requested for the product, these must be approved for the EU food industry.

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Q&A​ about product authorisation ​

With​ who​​​​m should I apply for product authorisation (disinfectant/teat disinfectant product)?​

If all active substances in a product are approved, then an application must be made under the BPR. 

How do I ge​​​​t my disinfectant/ teat disinfection product approved under the national authorisation scheme?

If your product is covered by the DVFA's national authorisation scheme, you must submit an application form, which you can find here on the DVFA's website.

 

How long is the pr​​​ocessing time for a product authorisation?

The processing time at the DVFA for a product authorisation is approximately 5-6 months.

 

What is the pri​​ce of a product authorisation?

The case handling fee amounts to DKK 13,300. For parallel authorisation s of products that are no more than 5 years old and do not require further toxicological assessment, the fee is approx. DKK 5,000. The fee rates will be adjusted annually.

 

How long is a prod​​​uct apprival under the national authorisation scheme valid?

A product authorisation by the DVFA under the national authorisation  scheme has no end date. It is therefore not necessary to renew an authorisation. All authorisation s under the Danish national authorisation scheme will expire when the area is fully regulated by the BPR.

 

What are the requi​​​rements for applying for product authorisation of a disinfectant/ teat disinfection product at the DVFA?

An application for product authorisation by the DVFA must comply with the following requirements:

  • All fields in the application form must be filled in.Evidence that the disinfectant or teat disinfection products has a technological effect in accordance with applicable European standards. The products must meet the requirements for technological effect by having either a bactericidal or a fungicide effect or both.
  • Evidence that the product contains active substances that are approved or in the process of being approved in the EU review programme.
  • Evidence that the active substance supplier is registered in the Article 95 list.
  • In the case of parallel authorisation, the company must demonstrate that the product is identical to the product already approved.
Can you a​​​​pply for product authorisation under the national authorisation scheme even if you are not established in Denmark?

There is no requirement for the applicant company to be established in Denmark.

However, if the active substances in the product are approved under the BPR, the product must be approved under the BPR, and this regulation there is a requirement that the authorisation holder is established within the EU.

 

Can you change the​​​ product name of a product approved by the DVFA?

No. According to the DVFA's authorisation, if an approved product is changed, being tha​t the composition, use, trade name or similar product qualities, this requires a new authorisation from the DVFA. It is not possible to correct the trade name associated with an authorisation. If you wish to market a product under a different trade name, a new application must be sent to the Danish Veterinary and Food Administration (DVFA).

However, it is possible to place several products on the market under the same trade name if they have identical composition, use, concentration of active substance and the like, and only the quantity in the product is different.

 

Can you chang​e the authorisatio​​​n holder for a specific product authorisation by the DVFA?

Yes. However, thi​s requires that the request and documentation come from the original authorisation holder.  The original applicant company must confirm to the DVFA that they wish to transfer the authorisation to another company, which will then become the new authorisation holder for the product in question.

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Last Modified 1. August 2022