Article 1

Chapter XIII of Annex II to the EEA Agreement shall be amended as follows:

1. 1..

   The following text is inserted after the words ‘Committee on Orphan Medicinal Products (COMP)’ in the 13th paragraph of the introductory text:

   ‘, the Paediatric Committee’

2. 2..

   The following indent is added in points 15q (Directive 2001/83/EC of the European Parliament and of the Council) and 15zb (Regulation (EC) No 726/2004 of the European Parliament and of the Council):

   • ‘ 32006 R 1901: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 (OJ L 378, 27.12.2006, p. 1).’

3. 3..

   The adaptation text of point 15zb (Regulation (EC) No 726/2004 of the European Parliament and of the Council) is replaced by the following:

   ‘The powers vested in the European Commission in relation to the infringement procedure foreseen in Article 84(3), including the power to impose financial penalties on the holders of marketing authorisations, shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by the EFTA Surveillance Authority in close cooperation with the Commission. Before the EFTA Surveillance Authority takes a decision regarding financial penalties, the Commission shall provide it with its assessment and a proposal on how to act.’

4. 4..

   The text of point 15zj (Commission Regulation (EC) No 658/2007) is replaced by the following:

   ‘ 32007 R 0658: Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10), as amended by:

   • 32012 R 0488: Commission Regulation (EU) No 488/2012 of 8 June 2012 (OJ L 150, 9.6.2012, p. 68), as corrected by OJ L 338, 12.12.2012, p. 44.

   The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:

   The powers vested in the European Commission in relation to the infringement procedure, including the power to impose financial penalties on the holders of marketing authorisations, shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by the EFTA Surveillance Authority in close cooperation with the Commission. Before the EFTA Surveillance Authority takes a decision regarding financial penalties, the Commission shall provide it with its assessment and a proposal on how to act.’

5. 5..

   The following point is inserted after point 15zo (Commission Implementing Regulation (EU) No 198/2013):

   ‘15zp.

   32006 R 1901: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1), as amended by:

   • 32006 R 1902: Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 (OJ L 378, 27.12.2006, p. 20).

   The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

   1. (a)

      The application of Article 36(3) shall not be made dependent on an authorisation of the medicinal product in Liechtenstein.

   2. (b)

      The powers vested in the European Commission in relation to the infringement procedure foreseen in Article 49(3), including the power to impose financial penalties on the holders of marketing authorisations, shall, in the cases where the marketing authorisation holder is established in an EFTA State, be carried out by the EFTA Surveillance Authority in close cooperation with the Commission. Before the EFTA Surveillance Authority takes a decision regarding financial penalties, the Commission shall provide it with its assessment and a proposal on how to act.’.