8Under Article 6(1) of that directive:‘No medicinal product may be placed on the market of a Member State unless [an MA] has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use [(OJ 2006 L 378, p. 1)] and Regulation (EC) No 1394/2007 [of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2007 L 324, p. 121)].When a medicinal product has been granted an initial [MA] in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial [MA]. All these [MAs] shall be considered as belonging to the same global marketing authorisation, ...’
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