Derived authorisation

Characteristics

The legal basis

A derived authorisation is based on an existing, fully assessed (Dutch) authorisation. The derived product has the same composition and the same uses and types of packaging (or less) as the original product, and is authorised for the same period as the authorisation of the original product. Products authorised via a derived authorisation can be sold and used in the Netherlands.

Important

Applications for a derived authorisation under transitional legislation can be submitted up to 90 days before the date of re-registration of the original authorization. Under the regulation derived trade authorizations don’t excists.

Application type criteria

For a derived authorisation, the following conditions must be complied with:

• A derived trade application can be submitted up to 90 days before the date of re-registration of the original authorisation.
• The derived product will be placed on the market under a trade name different from the mother authorisation.
• The trade name of the derived product must not cause confusion or be too generic (Government Gazette 2016, nr. 5466 (only available in dutch).
• The derived product is identical in terms of formulation and packaging to the original product, also called the mother.
• The derived product originates directly or indirectly from the authorization holder of the original product (already authorized in the Netherlands). Indirect origination means that the product has been obtained through the wholesale trade, but has indeed been manufactured by, and originated from, the authorization holder of the original product. So a derived trade authorization cannot be based on another derived authorization.
• The holder of the original authorization explicitly consents to the original authorization being used for the derived product.
• It should be declared how the Article 95 requirements are met. For this purpose this declaration  must be used. On the ECHA website additional information is avialable about the procedure for being included on the Article 95
• The WG(GA) of the derived product contains no uses other than the uses listed on the WG(GA) of the “mother” authorization.  If you want to list fewer uses than the original product authorization, 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 authorization that is identical for the original authorization, you can indicate that on the application form. In that case, you do not have to include a WG(GA).
• The text of the WG(GA) must be the same as  the text 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.

Check for completeness application

The application for a derived trade authorization requires submission of

• a completed Form AB;
• a completed and signed declaration of the authorization holder of the original product that confirms that he agrees with issuing of a derived trade authorization based on the authorization of his product (printed on the official stationery of the original authorization holder);
• the applicant declaration, that confirms that the derived trade authorization is identical to the original product and supplied by the authorization 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.

Registration process

For this kind of minor applications a notification before submission, which is obligated for a number of applications, is not necessary, and also the intake process isn’t a part of the process. This application may be submitted until 90 days before the renewal of the reference authorisation.

New derived authorisation

For new derived authorizations you have to use Form AB. The Ctgb aims to handle the application for authorization within 10 weeks, provided that the request is complete. The decision will be sent by regular mail.

Prolongation of the derived authorisation

For prolongations you have to use Form AB also. We try to handle this application as soon as possible, after the original authorization is prolonged, provided that the request is complete.

Changes and withdrawal of the derived authorisation

For changes of the authorization or how to withdrawal the authorization see:  Administrative changes, minor changes and withdrawals. The changes must be in line with the original product, so you only can request for administrative changes: changes based on the review of the original product.

Instructions for submission

Preferably send the application to post@ctgb.nl. We don’t need a paper version. Please mention on the subject line of the e-mail the application type, product/active substance name and company name. Make sure the individual files have logical names. For example: “application form’’, “legal conditions for use/WG”. Please don’t submit a cover letter:  You will mention the changes on the application form clearly. If necessary, you can give an explanation in an appendix. In this case: Refer on the application form to the appendix.

Information about requirements applicant, payment method, language, product name see: Directions for submission

Fees

For this type of application an application fee needs to be paid. If the application results in an authorisation an annual fee needs to be paid.

The tariffs are published in the Government Gazette . The applicable tariff codes are mentioned on the application form.

Other important information

Withdrawal of the original authorisation

We would like to point out the following: If the original authorization is withdrawn by the authorization holder or the government, the derived trade authorization will withdraw too. The grace periods will be the same as the grace periods for the original product.

Renewal of the original authorisation

As mentioned above under regulation (EU) 528/2012 derived trade authorization don’t exist. If you want to remain the product on the market after the renewal of the original product you have to send:

• an application for a Same Biocidal Product or
• the authorization holder of the original product have to send an application to add a product name to the existing authorization.

If you didn’t send one of the above mentioned applications before the active substance is approved, the derived authorization will expire on the date of the approval of the active substance.