A parallel trade permit is an authorisation for the import of a plant protection product that is identical to a product already authorised in Denmark.
As parallel trade permits according to the EU regulations are not regarded as authorisations, a parallel trade permit can only be granted to an authorised plant protection product, and not to a product which has been granted a parallel trade permit. A parallel trade permit is valid only for Denmark. It is not valid in the rest of the Northern Zone. An application must be made in each country for which you wish to obtain a permit.
Identical products
A plant protection product is considered identical with a product already authorised in Denmark only if:
a) it is produced by the same company, or an associated company or under licence according to the same method of manufacture as that of the authorised product
b) it has the same specification, that is, contains the same active substances, safeners and synergists. The plant protection product is of the same formulation type
c) the contents of the co-formulants and the packaging are the same or equivalent. The packaging and co-formulants may not have more negative effects on health or the environment than the original product.
Requirements for the application procedure
For the Danish EPA to assess whether the requirements for identicality have been met, your application for a parallel trade permit must contain the following information:
a) the name and registration number of the plant protection product in the country of origin
b) the country or countries of origin
c) the name and address of the holder of the authorisation in the country of origin
d) the label from the country of origin, if the Danish EPA so requires. A translation may also be required
e) the name and address of the applicant for a parallel trade permit
f) the name that the plant protection product will carry if authorised in Denmark
g) a draft Danish label
h) a sample of the product, if requested by the Danish EPA
i) the name and registration number of the product already approved in Denmark.
Application form for a parallel trade permit
The application can be emailed pesticider@mst.dk or submitted to:
The Environmental Protection Agency, Pesticides
Tolderlundsvej 5
DK-5000 Odense C
Processing time
Up to 55 days.
Fees
As of 1 January 2014 fees for processing applications for Plant Protection Products were introduced. Read more on fees.
Note that fees will also be charged for the renewal of a parallel permit.
When the reference product is in the process of being renewed, The Danish EPA will ask the authorisation holder to submit an application for renewal and fees will be charged upon receipt of the application.
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.
An annual fee of DKK 500, together with the relevant duties due to the Danish Tax and Customs Administration, is payable for each permit.
Regulations
The requirements for parallel trade permits are described in detail in Article 52 of Regulation No 1107/2009.