Commission Regulation (EC) No 1234/2008Dangos y teitl llawn

Article 2 Definitions

For the purposes of this Regulation, the following definitions shall apply:

1.

‘Variation to the terms of a marketing authorisation’ or ‘variation’ means an amendment to the contents of the particulars and documents referred to in:

(a)

Articles 12(3), 13, 13a, 13b, 13c, 13d and 14 of Directive 2001/82/EC and Annex I thereto, and Article 31(2) of Regulation (EC) No 726/2004 in the case of veterinary medicinal products;

(b)

Articles 8(3), 9, 10, 10a, 10b, 10c and 11 of Directive 2001/83/EC and Annex I thereto, Article 6(2) of Regulation (EC) No 726/2004, point (a) of Article 7(1) and Article 34(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council(1) and Articles 7 and 14(1) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council(2) in the case of medicinal products for human use;

2.

‘Minor variation of type IA’ means a variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;

3.

‘Major variation of type II’ means a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned;

4.

‘Extension of a marketing authorisation’ or ‘extension’ means a variation which is listed in Annex I and fulfils the conditions laid down therein;

5.

‘Minor variation of type IB’ means a variation which is neither a minor variation of type IA nor a major variation of type II nor an extension;

6.

‘Member State concerned’ means a Member State whose competent authority has granted a marketing authorisation for the medicinal product in question;

7.

‘Relevant authority’ means:

(a)

the competent authority of each Member State concerned;

(b)

in the case of centralised marketing authorisations, the Agency;

8.

‘Urgent safety restriction’ means an interim change to the product information due to new information having a bearing on the safe use of the medicinal product, concerning in particular one or more of the following items in the summary of product characteristics: therapeutic indications, posology, contra-indications, warnings, target species and withdrawal periods.

(1)

OJ L 378, 27.12.2006, p. 1.

(2)

OJ L 324, 10.12.2007, p. 121.