Registration process and instruction for submission
The Ctgb aims to provide the information requested within 10 weeks, provided that the request is complete. You will receive a response from Ctgb by regular mail. This will be a decision on your application.
Instructions for submission
|Applicationtypes derived trade permit||Form and type:||Handling period*|
|Trade permit||Form AG||10 weeks|
|Prolongation||Form AG, choose VAG||10 weeks|
|Expanding field of use||Form AG, choose UAG||10 weeks|
|Restriction of the field of use||Form WI, choose NLWATG||12 weeks|
*No rights can be derived from these handling periods.
The fees charged for these types of derived trade permit, can be found in the Ctgb Tariff decree.
Legal Conditions for Use and Instructions for Use (WGGA).
No uses may be listed on the draft WG(GA) other than the authorised uses for the reference product.
If you want to list fewer uses than the original product trade permit, then your application must include a draft proposal of the Legal Conditions for Use and Instructions for Use (WGGA). This must be the text as it will appear on the packaging.
If you want a derived trade permit that is identical for the original trade permit, you can indicate that on the application form. In that case, you do not have to include a WG(GA).
The text must be the same as that on the packaging of the original product and can be supplemented with technical instructions, if these are not prejudicial to the technical instructions on the label of the original product.
Note: The field of use of the derived trade permit must be the same (or smaller) than the original trade permit. Frequently, we receive applications for trade permits and applications to amend the field of use for wich the “mother”- authorisation (the original authorisation) is not expanded yet. Therefore these applications could not be handled. To avoid large numbers of unfinished applications or rejections, the policy of the Ctgb is that trade permit applications and applications to expand the field of use, for derived trade permits, can only be considered when the original authorisation is authorised for this field of use already.
Check for completeness application
The application for a derived trade permit requires submission of
- a completed Form Derived trade permit PPP;
- a completed and signed declaration of the authorisation holder of the original product that confirms that he agrees with issueing of a derived authorisation based on the authorisation of his product (printed on the official stationery of the original authorisation holder);
Important: withdrawing of this declaration does not lead to witdrawing of the derived trade permit.
- the applicant declaration, that confirms that the derived trade permit is identical to the original product and supplied by the authorisation holder of the original product;
- draft WG(GA) (Legal Conditions for Use and Instructions for Use)
It is obligatory to use the templates that have been added to the application form. Other declarations will not be accepted.