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Characteristics

The legal basis

The Ministry of Agriculture, Nature and Food Quality has requested the Ctgb to process applications for a derived authorisation of plant protection products based on the ‘Guidance document on renewal (Withdrawal and amendment of authorisation under Regulation (EC) 1107/2009)’. This means that applications for a derived trade permit of a plant protection product can be processed administratively based on the original authorisation. This approach is defensible from the perspective of the risk assessment because the derived trade permit is identical to the previously assessed original authorisation. On 29 August 2012, the Board approved this decision.

Application type criteria

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

  • The derived product  is based on an existing fully assessed Dutch authorised plant protection product: the original product (also called the ‘’mother”).
  • The derived product will be placed on the market under a product  name different from the  original authorisation.*
  • The 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 ( fewer types or packaging are possible).
  • 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.
  • The holder of the original authorisation explicitly consents to the original authorisation being used for the derived product. Import: Withdrawing of the declaration does not lead to witdrawing of the derived authorisation.
  • The WG(GA) of the derived product contains no uses other than the uses listed on the WG(GA) of the “original” authorisation.
  • It is obligatory to use the templates that have been added to the application form. Other declarations will not be accepted.

*) see 'Beleidsregel naamgeving toegelaten gewasbeschermingsmiddelen en biociden' for information about acceptable product names.

Scope of the derived authorisation

With this permit the product can only be sold and used in the Netherlands.

Duration period product authorisation

A derived authorisation applies for the same period as the original  product.

Changes of the original product

If the authorisation holder for the original product submits a request to change the authorisation in accordance with PPPR 1107/2009, art. 45.1, also the derived authorisationmust be changed. The authorisation holder of the original product is obliged to inform the authorisationholder of the derived product, so they can also send an application for a change to Ctgb.

To avoid large numbers of unfinished applications, the policy of the Ctgb is that the application for change for the derived authorisation, can only be send to Ctgb when the original authorisation is already changed (not earlier).

Exceptions:

  • Expanding the field of use is excepted (It is not obligatory to expand the derived permit too).
  • If the authorisation holder of the original product changes the package or shelf life we also don’t need an application. The reason for this is that we don’t mention this information in the permit. Of course the authorisation holder of the original product must also inform the derived authorisation holder about the changes in the packaging and the shelf life: the derived product must be in line with the original product.

Renewal derived authorisation

For renewal of a derived authorisation some relevant information can be found under 'Product renewals'  (NL=zRMS and NL=CMS).

Withdrawal original product

Withdrawn by the authorisation holder

If the authorisation holder for the original product submits a request to withdraw the authorisation in accordance with PPPR 1107/2009, art. 45.1, also the derived authorisation must be withdrawn. So the authorisation holder of the original product must inform the holder of the derived trade permit, so the holder of the derived trade permit can also send an application for a withdrawal to the Ctgb.

Withdrawn by the authority

If the original product has been withdrawn by the authority (article 44), the derived authorisation will be withdrawn as well, with the same grace period for  disposal, storage, placing on the market and use of existing stocks. “Registration process and instructions for submission”.

Grace periods on derived permits

See the last paragraph on the page  Grace periods.