Parallel trade permit
A permit for paralleltrade is a authorisation to import a product from a EU member state to place it on the Dutch market. The product is identical to a product already authorised in the Netherlands. With this permit the imported product can be sold and used in the Netherlands.
The objective of granting authorisation for parallel trade is to promote the free movement and availability of goods in the Member States. The free circulation of biocides 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.
The application for a parallel permit should be send to the European Chemicals Agency (ECHA) and the national authorities by R4BP.
Important
The application must be submitted if the renewal authorisation of the reference product is approved, not earlier. Has the renewal application of the reference product not been approved yet: up to 90 days before the date of re-registration of the reference product you can send an application for parallel trade under transitional law.
Characteristics
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:
- The renewal authorisation of the reference product must be approved.
- The application should be send by R4BP.
- The imported product is authorized in a member state of the EU as a biocide.
- The imported product is identical to an authorized biocide (the reference product) as mentioned in Sanco guideline 10524/2012 (July 2015, Version 5.2, chapter 4). For biocides there is no guidance, so we use the guidance for plant protection products.
- 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.
- 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.
- If the product is repacked, the new package must not be harmful.
Applicants
For this type of applications also third parties may apply for a product authorisation. Third parties that are allowed to apply for a parallel trade permit are:
- official or scientific bodies involved in agricultural activities;
- professional agricultural organisations or
- professional users.
Registration process
For this kind of applications a notification before submission - which is obligated for a number of applications - is not necessary. For this type of application is no separate step foreseen for intake of the application.
New parallel permit
An application for an parallel permit under the BPR must be submitted if the renewal authorization of the reference product is approved, not earlier. The application should be handled within 60 days (depending on the speed at which the concerned Member States sent the requested information. Please note that the application process takes longer).
Prolongation of the parallel permit
We try to handle this application as soon as possible after the original authorisation is prolonged, provided that the request is complete. We are depending on the speed at which the concerned Member States sent the requested information. Please note that the application process takes longer),
Changes and withdrawals of the parallel authorization
For information about changes and withdrawals, see: Minor, administrative amendments and withdrawal
Instruction for submission
The application should be send to the European Chemicals Agency (ECHA) and the national authorities by R4BP. For more information about how to submit an application to R4BP see How to use R4BP3. For information about requirements authorisation holder, language, product names, fees and charges, spc and declaration article 95 see: Directions for submission biociden
Important remark for applications for a new parallel permit:
After you have logged in on R4BP you have to select for example ‘PP-APP – Parallel trade' in ‘NEW APPLICATION' tab and enter the reference numbers (the national authorisation asset number in the Member State of origin and the national authorisation asset number in the Member State of introduction) to launch the application ‘wizard', which will guide you through the various steps of the submission process. Please add in R4BP an accompanying letter in which you mentioned the travel name(s) of the new product.
Fees
For this kind of applications you have to pay application fees and annual fee. The tariffs are published in the Government Gazette. The tariff codes you find on the application form.
Other important information
Import of the product
After you received the authorization you are allowed to import the product one day after informing the enforcement (mailadrress is in the notification form) 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 enforcement and the Ctgb immediately (or you have permission of the enforcement to show the identity of the imported product on another way). You must keep the products in the original packaging, for 2 consecutive working days so that the enforcement can carry out an inspection.
Remark
The permit is only granted for the batch numbers which are send to the enforcement and Ctgb.
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 a biocide 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 authorization holder of the reference product, to correct the label. In this case an application is needed from the authorization holder of the parallel permit.
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. In this case the authorisation holder must send a request via ECHA to withdrawal this authorisation too. - Withdrawn by the authority
If the reference product has been withdrawn by the authority, the parallel trade permit will withdraw too by the authority with the same grace period for disposal, storage, placing on the market and use of existing stocks.