Derived authorisation

This derived authorisation process is valid for

  • new derived authorisations
  • renewals of derived authorisations
  • expanding the field of use of a derived authorisation
  • restriction of the field of use of a derived authorisation

Characteristics

A derived authorisation is based on an existing, fully assessed authorisation in the Netherlands (the original product). The product authorised by a derived authorisation is completely identical to the original product, but is being marketed under a different name.

Under Biocidal products regulation (EU) 528/2012 derived authorisations don’t exist. During the transition from Dutch law to the Biocidal Products Regulation the policy of Ctgb is that applications for a derived authorisation can be submitted up to 90 days before the date of re-registration of the original authorisation. See also our recommendations to limit the duration of a possible 'market freeze'.

Products authorised via a derived authorisation can only be sold and used in the Netherlands.

The legal basis

Plant protection products and biocidal products Act, article 52 Wet gewasbeschermingsmiddelen en biociden (in Dutch)

Application type criteria

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

  • A derived authorisation can be submitted up to 90 days before the date of re-registration of the original authorisation. The derived product (“child”) is based on an existing fully assessed Dutch authorised biocide (original product/mother).
  • 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.
  • The derived product is identical in terms of formulation and packaging to the original product.
  • The derived product originates directly or indirectly from the authorisation holder of the original product (already authorised 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 authorisation holder of the original product. So a derived authorisation cannot be based on another derived authorisation.
  • The holder of the original authorisation explicitly consents to the original authorisation being used for the derived product.
  • The WG(GA) of the derived product contains no uses other than the uses listed on the WG(GA) of the “mother” authorisation.

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..

Information about acceptable product names : Beleidsregel naamgeving toegelaten biociden en gewasbeschermingsmiddelen (only in Dutch, Governement Gazette 2016, nr. 54661).

Duration period product authorisation

A derived authorisation applies for the same period as the authorisation of the product already authorised in the Netherlands. If the authorisation holder for the reference product submits a request to withdraw the authorisation, also the derived authorisation will be withdrawn.

Registration process

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.

Application types derived authorisation

Form and type:

Handling period*

Authorisation Form AB 10 weeks
Prolongation Form AB, choose VAB 10 weeks
Expanding field of use Form AB, choose UAB 10 weeks
Restriction of the field of use Form WI, choose WWGGA 12 weeks

*No rights can be derived from these handling periods.

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 authorisation, 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 authorisation that is identical for the original authorisation, 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 authorisation must be the same (or less) than the original authorisation. Frequently, the Ctgb receives applications for authorisation and applications to amend the field of use for which 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 authorisation applications and  applications to expand the field of use, for derived authorisations, 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 authorisation requires submission of

  • a completed form Derived authorization AB;
  • 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);
  • the applicant declaration, that confirms that the derived authorisation 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.