The Veterinary Medicines Regulations 2013

Action taken on account of pharmacovigilanceE+W+S

This section has no associated Explanatory Memorandum

61.—(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation [F3, or a group of marketing authorisations containing the same active substance,] should be—

(a)suspended;

(b)revoked; or

(c)varied so as to—

(i)restrict the indications;

(ii)change the distribution category;

(iii)amend the dose;

(iv)add a contraindication; F4...

(v)add a new precautionary measure, [F5or

(vi)implement a risk management plan,]

the Secretary of State must forthwith inform F6... and the marketing authorisation holder.

(2) If urgent action is necessary for protecting human or animal health, the Secretary of State may suspend the marketing authorisation of a veterinary medicinal productF7....

F8(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F9(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Action taken on account of pharmacovigilanceN.I.

61.—(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation should be—

(a)suspended;

(b)revoked; or

(c)varied so as to—

(i)restrict the indications;

(ii)change the distribution category;

(iii)amend the dose;

(iv)add a contraindication; or

(v)add a new precautionary measure,

the Secretary of State must forthwith inform the Agency, all F10... member States (irrespective of whether the product is authorised in [F11a] member State) and the marketing authorisation holder.

(2) If urgent action is necessary for protecting human or animal health, the Secretary of State may suspend the marketing authorisation of a veterinary medicinal product, but must inform the Agency, the Commission and the F12... member States within one working day.

(3) If, following the opinion of the Agency, the Commission requests the Secretary of State to suspend, withdraw or vary the marketing authorisation, the Secretary of State must comply with that request immediately on a temporary basis.

(4) The Secretary of State must take final measures in accordance with the Decision of the Commission.

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments