TITLE III U.K. MARKETING

CHAPTER 3 U.K. Procedure for marketing authorization

Article 27 U.K.

1. After a marketing authorization has been issued, the holder must, in respect of the manufacturing methods and control methods provided for in Article 12(3)(d) and (i), take account of scientific and technical progress and introduce any changes that may be required to enable that veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

These changes shall be subject to the approval of the competent authorities of the Member State concerned.

[F1 2. The competent authority may require the applicant or the marketing authorisation holder to provide sufficient quantities of the substances to enable controls to be made on the identification of the presence of residues of the veterinary medicinal products in question.

At the competent authority's request, the marketing authorisation holder shall provide his technical expertise to facilitate the implementation of the analytical method for detecting residues of the veterinary medicinal products in the national reference laboratory designated under Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (1) .

3. The authorisation holder shall immediately supply the competent authority with any new information that might entail the amendment of the particulars or documents referred to in Articles 12(3), 13, 13a, 13b and 14 or Annex I.

In particular, he shall immediately inform the competent authority of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is placed on the market and of any other new information which might influence the assessment of the benefits and risks of the veterinary medicinal product concerned.

In order to permit continuous assessment of the risk-benefit balance, the competent authority may at any time ask the marketing authorisation holder to forward data demonstrating that the risk-benefit balance remains favourable.]

F2 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F1 5. The marketing authorisation holder shall immediately inform the competent authorities, with a view to authorisation, of any alteration which he proposes to make to the particulars or documents referred to in Articles 12 to 13d.]

Textual Amendments

F1 Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.

F2 Deleted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.

(1)

[F1 OJ L 125, 23.5.1996, p. 10 . Directive as amended by Regulation (EC) No 806/2003 ( OJ L 122, 16.5.2003, p. 1 ).]

Textual Amendments

F1 Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.