Explanatory Memorandum to COM(2006)616 - For duty-free treatment for specified pharmaceutical active ingredients bearing an "international non-proprietary name" (INN) from the World Health Organisation and specified products used for the manufacture of finished pharmaceuticals and amending Annex I to Regulation (EEC) No 2658/87

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The Council is hereby invited to authorise the addition of 1290 pharmaceutical and chemical products to the already-existing list of 7329 products benefiting from bound duty-free treatment upon importation into the EU.

The EC grants duty-free treatment to imports of 7329 products, as provided for under the 1994 Record of Discussions on trade in pharmaceutical products agreed upon within the World Trade Organisation.

A third review of the products covered by the Record was launched in 2000, in accordance with Article 3 of the Record, which requires Participants to review at least once every three years the product coverage with a view to including additional pharmaceutical products for tariff elimination. The EC participated in these technical discussions. In the course of these discussions, Participants concluded that additional INNs and intermediates used for production and manufacture of finished pharmaceuticals should be granted duty-free treatment and that the list of specified prefixes and suffixes for salts, esters or hydrates of INNs should be expanded, thereby adding 1290 new substances to the list of products eligible for duty-free treatment.

The Member States have been consulted during the technical discussions.

The Council is invited to adopt the attached proposal for a Council Decision amending Annex I to Council Regulation (EEC) No 2658/87 in order to extend duty-free treatment in the Community to the above-mentioned 1290 pharmaceutical and chemical products.