Parallell trade permits

Published 01.06.2015     Modified 17.08.2016

Authorisation for the import of a plant protection product that is identical to a product already authorised in Norway.

What is a parallel trade permit?

A plant protection product that is authorised in another Member State and is identical in composition to a plant protection product already authorised in Norway, can be given parallel trade permit in Norway. An approved parallel trade permit is valid only for Norway, and not the rest of the Northern zone, therefore an application must be made in each country for which you wish to obtain a permit.

Regulations

The requirements for parallel trade permits are described in Article 52 of Regulation (EC) No 1107/2009, which is included as Norwegian legislation through the EEA-agreement. Further details is described in the guidance document on parallel trade permits (newest version of SANCO 10524/2012), which must be followed when applying for a parallel trade permit.

What is required to get a parallel trade permit?

An authorisation to import and parallel trade a plant protection product can only be given if the Norwegian Food Safety Authority determines the product to be identical to a product that are already authorized in Norway.

Plant protection products are considered as being identical to the reference product when the following applies:

  1. they have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process;
  2. they are identical in specification and content to the active substance(s), safeners and synergist, and formulation; and
  3. they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human health, animal health or the environment.

Requirements of the application procedure

For the Norwegian Food Safety Authority to assess whether the requirements for identicality have been met, the application for a parallel trade permit must contain the following information:

  1. the name and registration number of the plant protection product in the country where the product is registered (Member State of origin);
  2. the Member State of origin;
  3. the name and address of the authorisation holder in the Member State of origin;
  4. the original label and instructions for the plant protection product in the Member State of origin. The Norwegian Food Safety Authority require a translation of the label to English or Norwegian.
  5. the name and address of the applicant;
  6. the name to be given to the plant protection product to be distributed in Norway (Member State of introduction);
  7. a draft label for the product intended to be placed on the market;
  8. a sample of the product which is intended to be introduced if this is considered necessary by the Norwegian Food Safety Authority;
  9. the name and registration number of the reference product in Norway
  10. information on repacking (if performed).

Regulation (EC) 1107/2009 does not prohibit re-packaging of plant protection products. Nevertheless, this is a crucial step in the parallel trade of plant protection products that usually creates the most concerns for MS. It is quite decisive for competent authorities to ensure traceability of the products, and especially whenever re-packaging occurs. A product repacked in a third country and imported to the EU cannot benefit from the provisions on parallel trade. Requirements concerning repacking can be found in the guidance document.

Case processing time

The case processing time is up to 55 days.

After receiving a parallel trade permit

A plant protection product under a parallel trade permit may only be placed on the market and used in accordance with the authorisation of the original product. The parallel trade permit will expire at the same time as the authorisation of the original product. If the authorisation of the original product is withdrawn for reasons other than safety reasons, the parallel trade permit will be similarly affected. The parallel trade permit can be withdrawn if the conditions of the permit are no longer met, which includes withdrawal of the original product authorisation for safety or efficacy reasons.

A list of approved parallel trade permits will be published on our website.

How to apply?

Application form

A complete application form, in accordance with the guidance document, must be filled out and sent to the Norwegian Food Safety Authority. Details on how to submit the application is included in the form.

Application - parallel trade

Guidance document

Guidance document concerning the parallel trade of plant protection products (SANCO 10524/2012 latest version)

New applicants

All companies that have no previously authorized plant protection product(s) in Norway have to submit a company/incorporation certificate.

Application fee

As of Regulation of 13th of February 2004 no. 406 regarding fees to the Norwegian Food Safety Authority, fees for processing applications for plant protection products are introduced. The fees cover all expenses related to the assessments according to the rules in the Regulation (EC) No 1107/2009.

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