The legal basis
The Ministry of Agriculture, Nature and Food Quality has requested the Ctgb to process derived trade permit 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 trade permit 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 (a 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 trade permit.
- 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 permit
With this permit the product can only be sold and used in the Netherlands.
Duration period product authorisation
A derived trade permit 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 trade permit must be changed. The authorisation holder of the original product is obliged to inform the permit holder 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 permit, can only be send to Ctgb when the original authorisation is already changed (not earlier).
- 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 change the package or shelf life we also don’t need an application. The reason for this is that we don’t mentioned this information in the permits. Of course the authorisation holder of the original product must also inform the derived permit holder about the changes in the packaging and the shelf life: the derived permit must be in line of het original product.
Renewal derived trade permit
For renewal of a derived trade permit 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 trade permit must be withdrawn. So the authorisation holder of the original product must inform the permit holder of the derived product, so the application holder of the derived authorisation 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 permit will withdraw too 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 Grace periods.