Parallel authorisations can be issued for products that are identical to existing authorised products in Denmark. The authorisation of an identical product follows a simplified procedure and incurs a significantly reduced fee.
When are products identical?
If a product is 100 per cent identical to an existing authorised product in Denmark, you may apply for parallel authorisation in Demark. The co-formulants must have identical CAS numbers, but need not necessarily be from the same manufacturer. The field of use must be the same or more restricted than for the original product and the doses for a parallel product must be the same as for the original product.
What documents must be submitted?
In order to demonstrate that a product is identical to an existing authorised product in Denmark, you must submit:
If you purchase the product from the original manufacturer
- A declaration from the manufacturer stating that you are purchasing the original product directly from the manufacturer and that the product is identical to the existing authorised product
- an invoice verifying that the product was purchased from the authorisation holder for the original product.
If you manufacture the product yourself
- Copy of licence or business agreement
- Information on the composition
- Safety Data Sheets (SDS) for all substances in the product
- The manufacturer of the active substance and co-formulants
For both types of parallel application, the following must also be submitted:
- Letters of Access (LoA) for both active substances and product.
- Signed printout of the application form from R4BP for each product. An application must be submitted in Denmark as the refer-ence Member State ("Product Authorisation"). Read more about R4BP.
- Proposed Danish label and user instructions if the product is to be placed on the market in Denmark
What should I do if I do not know the composition?
On occasions, parallel manufacturers do not know the complete composition down to the smallest detail. In such cases, the product can still be considered an identical product if the exact composition is submitted by the original manufacturer on behalf of the parallel manufacturer. The original manufacturer can for example do this through R4BP (”Delegate product”). Read more in the R4BP user guide on the European Commission website
What does authorisation of an identical product cost?
Authorisation of an identical product (parallel authorisation) currently costs DKK 5,530 (2012).
Read more about the fees.