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Paragraph 24 Refusal of a marketing authorisationI1

United Kingdom

(1)

The Secretary of State shall refuse to grant a marketing authorisation if the application does not comply with these Regulations.

(2)

In addition, he shall refuse to grant it if—

(a)

the data submitted with the application are inadequate;

(b)

the risk-benefit balance of the veterinary medicinal product is unfavourable;

(c)

the product has insufficient therapeutic effect;

(d)

the withdrawal period proposed by the applicant is not long enough to ensure that Council Regulation (EEC) No. 2377/90 is complied with, or is insufficiently substantiated;

(e)

the veterinary medicinal product is for a prohibited use;

(f)

the way that the product will be used will have an unnecessarily undesirable effect on the environment.

(3)

The Secretary of State may refuse a marketing authorisation—

(a)

if there is Community legislation pending that is incompatible with the requested authorisation; or

(b)

if he requests additional data and those data are not provided within such time limit as he may stipulate.

Annotations

Commencement

I1

Sch. 1 para. 24 in force at 1.10.2006, see reg. 1