Parallel Import procedures operated in the EU for pesticide products
The European Court of Justice judgement in the case ofKohlpharma GmbHvBundesrepublik Deutschland(C112/02) in April 2004 established that a parallel import application could not be rejected solely on the basis that the parallel(s) and the master product do not have common origin, i.e., are not made by the same manufacturer or their agents under licence.
In the light of this the UK will be revising its parallel import arrangements and revised procedures to take account of the judgment and other issues will be published later this year. In the meantime the principles by which we will now operate our parallel import arrangements are set out below:
- PSD will no longer require a parallel import to have a common origin with the UK master product, i.e. it need not be made by the same manufacturer or their agents under licence. However, where the manufacturer of the proposed imported product is different to that of the UK master product then it is more likely that the two formulations (including technical specifications of the active ingredients) will be different.
- To obtain an approval, it must still be established that a parallel import is “identical” to (materially the same as) the UK master product. Common origin is the best means by which this can be established. In the absence of common origin there are more likely to be differences with respect to formulation and active ingredient specifications. As a result the verification procedure may take longer.
- For parallel import approvals granted under the Plant Protection Products Regulations 2005 the product to be imported must still be authorised for use in the originating/exporting member state, which must be part of the European Economic Area (EEA).
- For parallel import approvals issued under Control of Pesticides Regulations the product to be imported must still be authorised for use in the country of export.
- For parallel import approvals granted under the Plant Protection Products Regulations 2005 the parallel importer must have a permanent address within the European Economic Area (EEA).
In all other respects PSD will continue to work within guidelines laid down in its currently published arrangements. These are being revised in the light of the above and we plan to issue a full Regulatory Update containing the revised arrangements shortly.
Contact details
If you have any comments on these revisions to our procedures for parallel import applications, please contact Matthew Wells on 01904 455749, email matthew.wells@hse.gsi.gov.uk or write to:
Matthew Wells
Room 312
PSD
Mallard House
3 Peasholme Green
Kings Pool
York
YO1 7PX
Update Reference
Regulatory Update 06/2006
Issued: 7 March 2006