Duplicate application

You can also submit a duplicate application based on the dossier of an original product for which you are the Marketing Authorisation Holder.

You must hold the dossier of the original product. The two products must have different trade names.

The application can be submitted through the national procedure if the original product only has a marketing authorisation in the Netherlands. If the Marketing Authorisation Holders of the original product and of the duplicate application are the same or linked, the application will be processed through the Decentralised (DCP) or Mutual Recognition Procedure (MRP) if the original product was authorised via the MRP or DCP. In the case of DCP or MRP, you have two options:

• Submit the application at national level to the EU Reference Member State (RMS) first. After that, you will be able to register the duplicate in other Member States through the MRP;
• Submit the application to the RMS and the other desired Member States in one go through the DCP.

You must use the European application form for a marketing authorisation application. The following information must be provided alongside the application:

• the same dossier (copy of Parts 1, 2, 3 and 4) as the original veterinary medicinal product. The requested product name and the Marketing Authorisation Holder are the only elements that may differ from the referenced veterinary medicinal product;
• A completed and signed Annex I from the Guidance for duplicate applications in mutual recognition and decentralised procedures;
• The European application form including all necessary appendices,
• WORD versions of the SPC, labelling and package leaflet in accordance with the Veterinary Medicinal Products Regulation. Please see the EMA website for the most recent template. The application must meet all requirements stated in the Veterinary Medicinal Products Regulation. If you refer to an older dossier, you may need to submit a variation (change) first to update the dossier and the product information of the original product.

After the marketing authorisation has been granted, the duplicate veterinary medicinal product will be a product in its own right. This means that the veterinary medicine does not have to remain identical to the reference product. You may submit applications for changes and substantiate those applications based on your own data. However, it is recommended that you continue to harmonise both dossiers.

Legal basis

The duplicate veterinary medicinal product does not have a separate legal basis under the Veterinary Medicinal Products Regulation. The legal basis of the original product also applies to the duplicate veterinary medicinal product. Unlike the informed consent application, the original product does not have to be based on a complete dossier.

Please note that the fee for the application for the duplicate veterinary medicinal product is also based on the fee for the original product.

Additional information

Please find more information on duplicate applications in the Guidance for duplicate applications in mutual recognition and decentralised procedures as published on the CMDv website.