Commission Working Document. Guidance document. The concept of ‘lawfully marketed’ in the Mutual Recognition Regulation (EC) No 764/2008

On 15 June 2012, the Commission adopted its first report on the application of Regulation (EC) 764/2008 (‘the Mutual Recognition Regulation’) and proposed that the Consultative Committee on Mutual Recognition should closely monitor, among other areas, the difficulties faced by economic operators when trying to demonstrate that a product has been lawfully marketed in another Member State.

To address this concern, this guidance document seeks to provide user-friendly guidance on the concept of ‘lawfully marketed’ in the Mutual Recognition Regulation. It will be updated to reflect experience and information from the Member States, authorities and businesses.

EUR-Lex: COM(2013)592: Follow the progress of this document through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2013:592:FIN

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