24.6.2017   

EN

Official Journal of the European Union

L 163/13

(1)

Miyarisan Pharmaceutical Co. Ltd has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of its EU representative of the holder of the authorisation stated in Commission Regulation (EC) No 903/2009 (2) and Commission Implementing Regulations (EU) No 373/2011 (3), (EU) No 374/2013 (4) and (EU) No 1108/2014 (5).

(2)

The applicant claims that Huvepharma NV Belgium has become the new representative for Miyarisan Pharmaceutical Co. Ltd for the feed additive 4b1830 preparation of Clostridium butyricum FERM-BP 2789 with effect from 12 January 2017. The applicant has submitted relevant data supporting its request.

(3)

The proposed change of the representative of the holder of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additives concerned. The European Food Safety Authority was informed of the application.

(4)

In order to allow Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium to exploit its marketing rights, it is necessary to change the conditions of the respective authorisations. Regulation (EC) No 903/2009, Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014 should therefore be amended accordingly.

(5)

Since safety reasons do not require the immediate application of the amendments provided for by this Regulation to Regulation (EC) No 903/2009, Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014, it is appropriate to provide for a transitional period during which existing stocks may be used up.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plant, Animals, Food and Feed,

(1)

In the Title, the words ‘holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Miyarisan Pharmaceutical Europe S.L.U’ are replaced by the words ‘holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium’.

(2)

In the Annex to Regulation (EC) No 903/2009, in the second column ‘Name of the holder of authorisation’, the words ‘Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.’ are replaced by the words ‘Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium’.

(1)

In the Title, the words ‘holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Miyarisan Pharmaceutical Europe S.L.U’ are replaced by the words ‘holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium’.

(2)

In the Annex to Implementing Regulation (EU) No 373/2011, in the second column, the words ‘Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.’ are replaced by the words ‘Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium’.

(1)

In the Title, the words ‘holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Miyarisan Pharmaceutical Europe S.L.U’ are replaced by the words ‘holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium’.

(2)

In the Annex to Implementing Regulation (EU) No 374/2013, in the second column, the words ‘Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.’ are replaced by ‘Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium’.

(1)

In the Title, the words ‘holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Miyarisan Pharmaceutical Europe S.L.U’ are replaced by the words ‘holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium’.

(2)

In the Annex to Implementing Regulation (EU) No 1108/2014, in the second column, the words ‘Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.’ are replaced by ‘Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium’.