Applicants may obtain a parallel trade permit in the Netherlands for a plant protection product authorised in another Member State, if the product is identical to a product already authorised in the Netherlands.
Products authorised via a parallel permit can only be sold and used in the Netherlands. Re-export of a product imported under a parallel trade permit to another Member State (stacked permits) is not allowed.
The legal basis
The parallel trade permit for plant protection products finds its legal basis in article 52 of Regulation 1107/2009.
Application type criteria
Requirements for parallel trade:
- The imported product is authorised in a member state of the EU as a plant protection product.
- The imported product is identical to an authorized plant production product (the reference product) as mentioned in SANCO guidline 10524/2012 (July 2015, Version 5.2, chapter 4).
- The name of the product which is applied must not be too generic or confusing. See Government Gazette (in Dutch), 2016, nr. 54661 Beleidsregel naamgeving toegelaten biociden en gewasbeschermingsmiddelen
- The field of use is equal to the reference product or the field of use is less.
The imported product is an original product (not a parallel trade permit). Re-export of a product imported under a parallel trade permit to another Member State (stacked permits) is not allowed.
For this type of applications also third parties my apply for a product authorisation.
Third parties that may apply for a parallel trade permit are:
- official or scientific bodies involved in agricultural activities;
- professional agricultural organisations or
- professional users
Please realize; in addition to application fees, you also have to pay an annual fee.
Scope of the permit
With this permit the imported product can be sold and used in the Netherlands.
Important: The permit is only granted for the batch numbers which are send by the authorization holder to the NVWA and the Ctgb one day before the day of import. For the notification you must use the form: Notification import plant protection product.
Import of the product
You are allowed to import the product one day after informing the NVWA and CTGB with the corresponding batch number. You have to use the form: Notification import plant protection product. The notified batches must imported in the original packages and you must notify the NVWA and the Ctgb immediately (or you have permission of the NVWA to show the identity of the imported product on another way)
The products must remain in the original package for 2 consecutive working days after the notification to NVWA and Ctgb, for the control purposes. After this 2 consecutive working days you are allowed to re labelling or repacking, conformity the application and the decision (or you have permission of the NVWA to show the identity of the imported product on another way).
The original batch number must mentioned on each product (or the original batch number must be traceable in the administration or one product of each batch in the original package for control purposes of the NVWA during the permit period).
The text of the legal instructions for use and the directions for use (WGGA) must be the same as will appear on the packaging. The text must agree with the text for the reference product, and may be supplemented with technical instructions if these instructions do not contradict those for the reference product.
Repackaging the product before resale in the Netherlands is permitted if this does not affect the quality and properties of the product. The Ctgb, based on data about the packaging, determines whether the new packaging provides the same risk protection and has the same quality as the packaging for the reference product (Sanco/223/2000 rev. 9, 6 December 2001, page 7). The importer is allowed to repackage the product if the rights and reputation of the authorisation holder of the original product are not harmed. The importer must notify the holder of the rights for the reference authorisation about the intention to market the product, and if necessary provide the holder with a sample of the product. The importer is the individual who is responsible for importing a plant protection product for trading and marketing the imported product that is to be authorised. This is the applicant for the parallel authorisation.
Import of a new batch
If you want to import a new batch under the same conditions, you have to notify this with the form: Notification import plant protection product again. You have to follow the same steps describe above under “import of the product’’.
Changes of the reference product
If the reference product changes, the parallel permit must change too (except for expand field of use), with the same deadlines as set for the authorisation holder of the reference product, to correct the label. In this case a new application form is needed from the authorisation holder of the parallel permit. For the right application form see “Registration process and instructions form submission” <link maken>.
Withdrawal of the reference product
Withdrawn by the authorisation holder
If the reference product has been withdrawn by the authorisation holder (article 45), the parallel trade permit will remain valid. The parallel trade permit will elapse on the date when the authorisation for the reference product would have normally elapsed. For the right application form see “Registration process and instructions for submission”.
Withdrawn by the authority
If the reference product has been withdrawn by the authority (article 44), the parallel trade 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”.
Renewal reference product
For renewal of parallel trade permits relevant information can be found under 'Product renewals (NL=zRMS and NL=CMS / Instructions for submission), under: Renewal of derived authorizations and parallel trade permits.
Grace periods on parallel trade permits
See Grace periods.