Application based on informed consent
If you want to apply for a marketing authorisation for a veterinary medicinal product that is identical to another veterinary medicinal product that is already on the market, you can do so with the informed consent marketing authorisation application.
With an informed consent marketing authorisation application, the application for a marketing authorisation is based on the complete referral with authorisation to another product (reference product). This reference product must be based on a complete dossier. You can also make an informed consent request based on a reference product of which you yourself are the marketing authorisation holder.
You must have the dossier of the reference product or have full access to it. The two products must have different trade names.
After approval of the marketing authorisation, the informed consent stands alone. This means that the veterinary medicinal product does not have to remain identical to the reference product. You can submit change requests and substantiate them based on your own data.
The European application form must be used for an application for a marketing authorisation. The following data must be provided with the application:
- Authorisation to apply for informed consent, in which you, as an applicant, also declare that you have the dossier of the reference product
- European application form with all the necessary annexes, including the description of the pharmacovigilance
- The original part II (quality part) of the reference product. You must hereby declare that the part II supplied is identical to part II of the reference product. If the reference product refers to a Drug Master File (DMF) from the manufacturer, you must also provide a Letter of Access for the DMF.
The legal basis of the informed consent procedure is Article 13 c of Directive 2001/82/EC.