Regulation (EU) 2016/793 to avoid trade diversion into the European Union of certain key medicines (codification)

What it is

codification of Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines. PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Council Regulation (EC) No 953/2003 has been substantially amended several times. On 1 April 1987, the Commission decided to instruct its staff that all acts should be codified after no more than ten amendments, stressing that this is a minimum requirement. The Conclusions of the Presidency of the Edinburgh European Council (December 1992) confirmed this, stressing the importance of codification. The Committee on Legal Affairs adopted the report by Laura FERRARA (EFD, IT) on the proposal for a regulation of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codified text). The committee recommended the European Parliament to adopt its position at first reading, taking over the Commission proposal as adapted to the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission. According to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question contains a straightforward codification of the existing texts without any change in their substance. The European Parliament adopted by 664 votes to 29, with 4 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codified text). Parliament adopted its position at first reading, taking over the Commission proposal. The proposal in question aims to codify Council Regulation (EC) No 953/2003 which has been substantially amended several times. The proposal contains a straightforward codification of the existing texts without any change in their substance. the criteria for establishing what is a tiered-priced product; the conditions under which the customs authorities shall take action; the measures which shall be taken by the competent authorities in the Member States. The term ‘tiered-priced product’ shall mean any pharmaceutical product which is used in the prevention, diagnosis or treatment of a disease, referred to in Annex IV, and which is priced in accordance with one of the optional price calculations set out in the Regulation, verified by the Commission or an independent auditor and entered in the list of tiered-priced products set out in Annex I. PURPOSE: the codification of Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines. LEGISLATIVE ACT: Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines (codification). CONTENT: in the interests of legal clarity and transparency, this…

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