Postponement of a comparative assessment

For product applications based on an active substance that is classified as Candidate for Substitution, a Comparative Assessment (CA) must be performed. The purpose of this CA is to prevent authorisation of new products for which alternatives are available with less impact on humans, animals and the environment. For this purpose, applicants should submit the CA form as an additional appendix to their dossier.

A CA is not required for some types of applications (minor uses, non-professional use, mutual recognition). Applicants can also request postponement of a comparative assessment under Article 50.3 of the Regulation. This Article states that the comparative assessment can be postponed if it is necessary to first acquire experience through use in practice. This postponement can be issued for a maximum of 5 years. The Ctgb will indeed issue this postponement if no experience has yet been acquired with this product.
The authorisation decision will state that a postponement of the comparative assessment has been issued on the basis of Article 50.3. The comparative assessment must therefore be completed within 5 years. For this purpose, a CA form must be submitted to the Ctgb no later than one year before the expiration of the postponement. The CA will then be carried out with the product assortment that is available at that time. The applicant is responsible for the timely submission of a new application. A dossier for which a CA has not been received on time will expire on the specified date.
The following must be submitted as part of a request for a postponed CA:

  • cover letter with reference to original application and authorisation number
  • CA form

In general, the expiration date of a product is the expiration date of the active substance + one year. However, the expiration date of a substance is sometimes extended. If this date falls after the postponed date of the comparative assessment, then the latter date becomes the norm. During a procedural renewal, a postponement of a comparative assessment will therefore be taken into account.