S.L. 437.47 Art. 27Holder to take account of scientific and technical progress.

(1) After a marketing authorisation has been issued, the holder must, in respect of the manufacturing methods and control methods provided for in regulation 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 Veterinary Services.

(2) The Veterinary Services 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 Veterinary Services’ 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 European Union Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products.

(3) The authorisation holder shall immediately supply the Veterinary Services with any new information that might entail the amendment of the particulars or documents referred to in regulations 12(3), 13, 13A, 13B and 14 or in the Schedule. In particular, he shall immediately inform the Veterinary Services 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 Veterinary Services may at any time ask the marketing authorisation holder to forward data demonstrating that the risk-benefit balance remains favourable.

(4) (Deleted by L.N. 82 of 2006).

(5) The marketing authorisation holder shall immediately inform the Veterinary Services, with a view to authorisation, of any alteration which he proposes to make to the particulars or documents referred to in regulations 12 to 13D.