Parallel trade permit

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:

1. A parallel trade application under transitional legislation can be submitted up to 90 days before the date of re-registration of the original authorisation.
2. The imported product is authorised in a member state of the EU as a biocide.
3. 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).
4. 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.
5. The field of use is equal to the reference product or the field of use is less.
6. 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 authorisations) is not allowed.

7. 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 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

New parallel authorisation

An application for a new parallel authorisation may be submitted until 90 days before the renewal of the reference authorisation* (transitional law).

* After this time the transitional law is no longer applicable, you must send the application through R4BP (Biocidal Product Regulation.)

You have to use Form PAB. The Ctgb aims to handle the application for authorisation within 55 days*, provided that the request is complete. The decision will be sent by regular mail.

Prolongation of the parallel authorisation

For prolongations you have to use Form PAB also. We try to handle this application as soon as possible*, after the original authorisation is prolonged, provided that the request is complete. The decision will be sent by regular mail.

*we are dependent on the speed at which the concerned Member States sent the requested information. Please note that the application process takes longer.

Changes and withdrawal of the parallel authorisation

For changes of the authorisation or how to withdrawal the authorisation see:  Administrative changes, minor changes and withdrawals. The changes must be in line with the original product, so you only can request for administrative changes: changes based on the review of the original product. We try to handle this applications within 12 weeks, provided that the request is complete. The decision will be sent by regular mail.

Instruction for submission

Preferably send the application to post@ctgb.nl. We don’t need a paper version. Please mention on the subject line of the e-mail the application type, product/active substance name and company name. Make sure the individual files have logical names. For example: “application form’’, “legal conditions for use/WG”. Please don’t submit a cover letter:  You will mention the changes on the application form clearly. If necessary, you can give an explanation in an appendix. In this case: Refer on the application form to the appendix.

Information about requirements applicant, payment method, language, product name see: Directions for submission biociden

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 authorisation you are allowed to import the product one day after informing the enforcement* 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.

 *for e-mail addresses see notification form.

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 authorisation 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 authorized. 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 authorisation 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 the application holder of the parallel authorisation should ensure that this change is also implemented in his parallel authorisation . So the application holder should send Form W to Ctgb.

Withdrawal of the reference product

Withdrawn by the authorisation holder

If the reference product has been withdrawn by the authorisation holder the parallel trade authorisation will remain valid. The parallel trade authorisation 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 to withdrawal this authorisation too (Form W).

Withdrawn by the authority

If the reference product has been withdrawn by the authority, the parallel trade authorisation will withdraw too by the authority with the same grace period for  disposal, storage, placing on the market and use of existing stocks.