Parallel Trade – Regulatory Framework

According to Article 52 of Regulation (EC) No 1107/2009, granting an approval for the parallel trade of plant protection products essentially leads to the same legal consequences as granting an authorisation for a plant protection product. In detail, this means:

Import / Placing on the Market

Plant protection products for which parallel trade has been approved may be imported and placed on the market in Germany as long as the approval is valid. However, they are not allowed to be placed on the market if an approval for parallel trade has been applied for and has been granted for the applicant's own use.

Labelling

A plant protection product intended for parallel trade must be labelled for import or placing on the market with its name, the name and address of the parallel trade approval holder and the number allocated by the Federal Office of Consumer Protection and Food Safety (BVL) on its approval. The labelling regulations according to Article 65 of Regulation (EC) No 1107/2009 and Article 47 of the German Plant Protection Act are still applicable. Such a label is not required if an approval for parallel trade has been applied for and has been granted for the applicant's own use. However, in these cases the owner of the approval must have the instructions for use for the reference product at his disposal.

Use

According to Article 52 (5) of Regulation (EC) No 1107/2009, a plant protection product intended for parallel trade is to be used in the same way as the corresponding reference product. The same fields of application, conditions of application and restrictions apply. This also applies when the reference authorisation is changed at a later date. Amendments to the reference authorisation according to Article 51 of the stated Regulation also apply to the parallel trade of plant protection products. Authorisations / approvals based on Article 53 (emergency situations in plant protection) and Article 54 (research and development) of the stated Regulation do not apply to the parallel trade of plant protection products.

Period of validity for parallel trade permits

The status of a parallel trade permit is linked to the status of the respective reference authorisation. If this ends as a result of expiry, revocation or withdrawal, the validity of any parallel trade permits issued also ends at the same time. If, for example, the authorisation of a reference product ends after 10 years, the validity of the permit expires as well at that time. This also applies if the reference product is subsequently reauthorised. If the plant protection product is still intended for parallel trade in this case, a new permit is required.

However, if the reference authorisation has been withdrawn at the request of the authorisation holder, and unless there are no other reasons for revocation or withdrawal, the validity of the parallel trade permit expires at the time when the reference authorisation would normally have expired.

Grace periods for sale and use of existing stocks

Article 52 (7) of Regulation (EC) No 1107/2009 refers, as regards sale and and use of stocks, to the provision in Article 46 of that Regulation. In this respect, plant protection products which have been brought into Germany and placed on the market there on the basis of a parallel trade permit are subject to the same rules as authorised plant protection products. This means:

A grace period of 6 months for sale and distribution of stocks applies after the parallel trade permit has expired (Article 28 (4) PflSchG).

A grace period of 18 months for use of existing stocks applies after the parallel trade permit has expired (Article 12 (5) PflSchG).

Grace periods may be restricted by EU legislation in individual cases.

Product observation and obligation to inform

The plant protection product supplier must observe his product in the same way as an authorisation holder. If he should have any new findings regarding the impact of the product on sale concerning human and animal health or the environment, he is obliged to inform the BVL straight away. Finally, like the authorisation holder, the supplier must inform the BVL annually as to which plant protection products and what amount have been imported into Germany and placed on the market there.