SCHEDULE 1Marketing authorisations F8in Great BritainF9in Northern Ireland

Annotations:
Amendments (Textual)

PART 8Pharmacovigilance

Action taken on account of pharmacovigilanceE161

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 F1... 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 productF4....

F63

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F74

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Action taken on account of pharmacovigilanceE261

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 F2... member States (irrespective of whether the product is authorised in F3a 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 F5... 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.