Judgment_paragraph 51 · PTC Therapeutics International Ltd v European Medicines Agency (T-718/15)

51[As rectified by order of 27 April 2018] As regards Regulation No 507/2006, its legal basis being Regulation No 726/2004, that also reflects the legislature’s intention that the MA procedure should be transparent. In addition, the provisions of Regulation No 507/2006 to which the applicant refers provide for the publication of certain information such as the specific obligations of the holder of a conditional MA and the timeframe for their completion (Article 5(3) of that regulation), the opinion of the CHMP given in the context of a renewal application for a conditional MA (Article 6(3) of that regulation) and the clear mention, in the patient package leaflet, of the conditional nature of the MA (Article 8 of that regulation). Those provisions, the sole purpose of which is to require the EMA to proactively publish that information, just like the provisions of Regulation No 726/2004, as was noted in paragraph 49 above, do not relate to the regulatory scheme on access to the documents submitted in the context of an MA application and cannot therefore under any circumstances be interpreted as providing for a special scheme in that regard.

PTC Therapeutics International Ltd v European Medicines Agency (T-718/15)

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