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COUNCIL OF THE EUROPEAN UNION
Brussels, 27 February 2007
6618/07
Interinstitutional File: 2006/0136 (COD)
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AGRILEG 28
ENV 115 CODEC 140
OUTCOME OF PROCEEDINGS from : dated :
Working Party on Agricultural Questions (Pesticides/Plant Protection Products) 20 February 2007
No. Cion prop. : 11755/06 + ADD 1-12 Subject :
Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market
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1.At its meeting on 20 February 2007, the Working Group on Agricultural Questions
(Pesticides/Plant Protection Products) composed of experts in the field of parallel imports held a detailed discussion on the difficulties in the practice of handling parallel imports.
2.
The Presidency summarized the results of the discussions at the end of the meeting as follows:
A.
Member States underlined the need
o o
o o
to achieve a harmonized approach on how parallel imports should be handled,
to ensure that the level of protection afforded by Directive 91/414/EEC is also
guaranteed for parallel imports of plant protection products,
to take into account specific differences between pharmaceuticals and PPP,1
to set up basic principles in the proposal for a Regulation revising the Directive
91/414/EEC,
IT suggests to add a new bullet point: o "to take into account that the market of PPPs is not yet harmonized, due to the many
compounds still under Peer review, and the pertinent approved products in Member States, the transitory regime as provided by art. 8(2) of the Directive 91/414/EEC is applied",
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o to define parallel import [also to clarify the question on common origin]
including the requirement that the active substance is listed in Annex I,1 o to provide for a simplified procedure for authorisation, including a procedure on
application and including various [basic] options where further evaluation is needed, o to set up an EU system of traceability of PPPs for an effective control of the
authenticity of PPPs against illegal trade, and o to include parallel import products in the general framework of the control
obligations for PPP in the proposal.
Member States are of the opinion that
o further detailed provisions may be developed by the Commission
in Commission Guidelines and/or in accordance with the procedure laid down in Article 76 (2)/(3) such as
§ Criteria for identity; and
§ Procedures to be followed by applicants and Member States.
B. The European Commission
o is open to reflect on accepting provisions on parallel imports as requested by
Member States; o agreed that safety is an important aspect with view to parallel imports; o stated that rules should be in line with Article 28 of the Treaty as interpreted by the
case law of the European Court of Justice; o understands that the rules on parallel import of pharmaceuticals apply mutatis
mutandis to PPP in the light of the current case law.
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3.The Presidency will present these results at the next meeting of the Working Party on Agricultural Questions (Pesticides/Plant Protection Products) on 28 February and 1 March 2007.
A second meeting on parallel imports will take place on 13 March 2007, in order to complete the examination of all relevant aspects of this issue.
1 UK considers that Article 8(2) allows Member States to follow national rules for parallel imports of products from outside EEA where active substance is under review and not yet in Annex I.
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