Parallel trade permit
This part of of registration manual is applicable for:
- Parallel authorisation (PAB)
- Prolongation parallel authorisation (VPAB)
- Expanding field of use (UPAB)
- Restriction of the field of use (WI/WWGGA)
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. When the parallel trade permit is granted, the product can be imported, sold and used in (only) 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 trade 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 or the environment.
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 imported product is authorised in a member state of the EU as a biocides.
- The imported product is identical to an authorised biocide (the reference product). Ctgb use the guideline for plant protection products: guideline SANCO/10524/2012, July 2015, Version 5.2, chapter 4, because until now there is no guideline for biocides available.
- The name of the product which is applied must not be too generic or confusing. See for information about acceptable product names: Beleidsregel naamgeving toegelaten biociden en gewasbeschermingsmiddelen (in Dutch, Government Gazette, 2016, nr. 54661
- The field of use is equal to the reference product or the field of use is less.
The text of the legal conditions 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, as long as these instructions do not contradict those for the reference product.
The permit is granted under the following conditions
- 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: use this Notification form. From that point, the product with the corresponding batch number can be imported.
- The notified batches must imported in the original packages and 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 2 consecutive working days you are allowed to re labeling 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).
Requirements during the permit period
During the permit period the authorization holder must have:
- one product of each batch in the original package for control purposes of the NVWA or
- the original batch number must mentioned on each product or
- or the original batch number must be reducible in the administration.
If you want to import a new batch, you have to mentioned this with form PAB . This notification is for free.
If the product is placed in a different package, this is defined as repackaging. After authorisation, the product can be imported into the Netherlands only in the original packaging. However, 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. See Sanco/223/2000 rev. 9, 6 December 2001 (page 7).
Marketing notification for repackaged product
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.
Changes of the reference product
If the reference product changes, the parallel permit must change too, with the same deadlines as for the authorisation holder to correct the label. In this case we need a new application form from the authorisation holder of the parallel permit.
If the reference product has 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.
If the reference product has withdrawn by the MS competent authority , the parallel trade permit will withdraw too with the same grace period for het disposal, storage, placing on the market and use of existing stocks.
If the reference product is renewed or administrative extended the expiry date of the parallel permit is extended to. In this case we need a complete dossier from the parallel authorisation holder.
Instructions for submission
On the form you find which information is needed. It is important that the request is completely filled in. If the application is not complete , you risk not obtaining the permit on time. If data are missing, you will only have one opportunity to correct this omission. If you do not use this opportunity, your application will not be taken into consideration. Below the most important forms with the handling period are given.
|Authorisation||Form PAB||8 weeks|
|Prolongation||Form PAB, choose VPAB||8 weeks|
|Expanding field of use||Form PAB, choose UPAB||8 weeks|
|Restriction of the field of use||Form WI, choose WWGGA||12 weeks|
|Notification import biocide (parallel import)||Notification import biocide (parallel import)||Not applicable; this is only a notification|
|Notification Article 95||Notification parallel trade permit biocides
Appendix article 95
|Not applicable; this is only a notification|
* No rights can be derived from these handling periods.
The application must be submitted to the competent authority of the importing Member State.
Form parallel trade permit
Application form for: parallel trade permit renewal of parallel trade permit expanding the field of use of the parallel trade ...
Notification parallel trade permit biocides Appendix article 95
Applicants may obtain a parallel trade permit in the Netherlands for a biocide authorised in another Member State, if the ...
Form WI; minor amendments and withdrawals
Application for an amendment or withdrawal of an authorisation for plant protection products and biocides. You cannot use form WI ...