Judgment_paragraph 67 · Novartis Europharm Ltd v European Commission (T-472/12)

67It follows from the foregoing considerations that, in the November 2005 edition of the document entitled ‘Notice to Applicants’, the Commission was correct to point out, in paragraphs 2.3 and 6.1.4 of Chapter 1 in Volume 2A of that document, which, while not legally binding, may provide a helpful reference point for a judicial assessment (Opinion of Advocate General Wahl in Olainfarm, C‑104/13, ECR, EU:C:2014:342, point 39), that ‘the global marketing authorisation contains the initial authorisation and all variations and extensions thereof, as well as any additional strengths, pharmaceutical form, administration routes or presentations authorised through separate procedures and under a different name, granted to the marketing authorisation holder of the initial authorisation …’ and that ‘for a reference medicinal product, the start of the data and market exclusivity periods is the date when the first marketing authorisation was granted in the Community’. Those provisions also state that ‘[a]ll additional strengths, pharmaceutical forms, administration routes, presentations as well as any variation and extensions have the same end point of the data and market exclusivity periods, namely 8 and 10 years after the first marketing authorisation was granted, respectively’ and, lastly, that ‘[t]his will apply even if the new presentation has been authorised to the same marketing authorisation holder through a separate procedure and under a different name’. That statement is equally valid as regards the regulatory 10-year data protection period applicable to medicinal products authorised under the centralised procedure before 20 November 2005 (see paragraph 43 above).