Application process

Applying for an authorisation

The applicant submits an application dossier to the Ctgb that complies with Europe and national regulations. For example, the information in the dossier must be obtained from studies conducted by independent laboratories that meet the criteria for “Good Laboratory Practice” and “Good Experimental Practice”. The Ctgb conducts a critical assessment about whether all the studies provided by the applicant meet these criteria.

All documents required for the assessment must be present in the dossier and must comply with the substantive requirements (read our general instruction and directions for submission.  The actual assessment begins only after the application dossier is complete.

Assessment

During the assessment, the possible exposures to substances for humans, animals and the environment are calculated. These calculated exposures are then compared with the safe values. In this way, the risks of using the product are specified. If the assessment indicates that the product can be used safely and that it is effective, then the Board will decide to authorise the product.

Assessment framework

The Ctgb assesses the risks in accordance with European law (regulations and directives). We refer to this as the assessment framework. The framework applies to all EU Member States. However, country-specific rules and requirements may also apply.

This determines the implementation of the assessment framework, including the risks and how these should be assessed and reviewed according to the prevailing laws and regulations. The adoption of these laws and regulations is a political process.

Decision

After the Secretariat has prepared a decision, a draft decision is submitted to the Board. The Board checks the draft decision to make sure it is correct and then makes a decision on the application (whether or not to authorise the product). All decisions concerning an authorisation can be appealed. See also Public disclosure of studies. 

Legal conditions for use

As part of the authorisation process, legal conditions for use are approved, which must be included on the label of the product. In addition, the Ctgb assigns an authorisation number (e.g. 12345 N or NL-1234567) that must also be included on the packaging, so users can see whether the product has indeed been authorised in the Netherlands.

Overview of authorisations

Most of the assessments of authorised products conducted by the Ctgb are publicly accessible. In this way, everyone can see the studies on which the Ctgb based its decision to grant an authorisation and the considerations that played a role in this process.