Once the dossier is complete, it still has to be submitted! Administrative documents may have to be generated according to national requirements and the type of application. For this step, it is important to know the right procedure and the right contact persons to whom to send the dossier. In certain circumstances, notification ahead of the project has to be submitted.
When to submit a dossier?
A dossier submission will be needed in the following circumstances.
- Approval of a new source of technical active substance.
- Approval of a new active substance.
- Renewal of active substances.
- Access to the active substance data.
- Authorization of a new product.
- Renewal of product authorization after renewal of an active substance.
- Extension of use of a registered product.
- Modification of a product registration.
What are the services provided by ENC ?
- ENC can manage the dossier submission at EU level for active substance and at zonal/national level (with a focus on BE, FR, NL, DE, IE and UK) for products.
- After a dossier has been submitted, ENC can also follow up the application.