Judgment_paragraph 180 · Laboratoire Pareva and Biotech3D Ltd & Co. KG v European Commission (T-337/18)

180As a preliminary point, it should be recalled that, pursuant to Annex V to Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8 and amending Regulation (EC) No 1896/2000 (OJ 2003 L 307, p. 1), Laboratoire Pareva was required to submit a complete dossier for PHMB (1415; 4.7) by 31 July 2007 at the latest. However, the evaluating competent authority only considered that dossier to be complete in January 2016. Up until that date, Laboratoire Pareva had the opportunity to submit all the studies and all the documents which were supposed to enable the evaluating competent authority to assess Pareva’s PHMB.

Laboratoire Pareva and Biotech3D Ltd & Co. KG v European Commission (T-337/18)

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