Parallel trade permit

A permit for paralleltrade is a permit to import a product from a EU member state to put it on the Dutch market. With this permit the imported product can be sold and used in the Netherlands.

The objective of granting parallel trade permits is to promote the free movement and availability of goods in the Member States. The free circulation of biocidesPPPs within the EU must be facilitated without posing any unnecessary barriers but at the same time safeguarding that the provisions in place do not pose any risk for human health, animals and/or the environment.

Do you want to apply for a permit, or do you want to change or prolong the permit, please read the information on this page.

Characteristics

Applicants may obtain a parallel trade permit in the Netherlands for a biocide authorised in another Member State, if the product is identical to a product already authorised in the Netherlands.

Note

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 biocides finds its legal basis in article 53, Regulation (EU) nr. 528/2012.

Application type criteria

Requirements for parallel trade:

  1. The imported product is authorised in a member state of the EU as a biocide.
  2. The imported product is identical to an authorised biocide (the reference product) as mentioned in SANCO guideline 10524/2012 (July 2015, Version 5.2, chapter 4).
  3. The name of the product which is applied must not be too generic or confusing. See Government Gazette, 2016, nr. 54661 Beleidsregel naamgeving toegelaten biociden en gewasbeschermingsmiddelen.
  4. The field of use is equal to the reference product or the field of use is less.
  5. 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.
  6. If the product is repacked, the new package must not be harmful.

Applicants

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:

  1. Official or scientific bodies involved in agricultural activities;
  2. Professional agricultural organisations or
  3. Professional users

Please be aware that 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 Human Environment and Transport Inspectorate (in Dutch Inspectie Leefomgeving en Transport; IL&T) and the Ctgb one day before the day of import. For the notification you must use the form: Notification import biocide.

Import of the product

You are allowed to import the product one day after informing the IL&T and CTGB with the corresponding batch number. You have to use the form: Notification import biocide. The notified batches must imported in the original packages and you must notify the IL&T and the Ctgb immediately (or you have permission of IL&T to show the identity of the imported product on another way).

The package

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 IL&T 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

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 the 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 again by filling out the Notification form import biocide.

You have to follow the same steps described 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 Directions for submission.

Withdrawal of the reference product

  • Withdrawn by the authorisation holder
    If the reference product has been withdrawn by the authorisation holder 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 Directions for submission.

  • Withdrawn by the authority
    If the reference product has been withdrawn by the authority (), the parallel trade permit will withdraw too with the same grace period for  disposal, storage, placing on the market and use of existing stocks. See Directions for submission.

Grace period

See our information on grace periods.

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.

Applications for parallel permits should be handled within 55 days.

Instruction for submission

For information about sending the forms, payment method and language, see Directions for submission. More information about this kind of applications can be found under Administrative and minor applications.

Fees

For this kind of applications you have to pay application fees and an annual fee.