PART 5Miscellaneous provisions, enforcement and offences

Appeals to an appointed person30

1

A person aggrieved by a provisional decision of the Secretary of State under regulation 29 may appeal against the decision to a person appointed for the purpose by the Secretary of State in accordance with this regulation.

2

So may an applicant for—

a

a manufacturing authorisation;

b

appointment as a Qualified Person for the purposes of a manufacturing authorisation;

c

authorisation for a person or premises to manufacture autogenous vaccines;

d

an authorisation of a blood bank;

e

authorisation of a person and premises to manufacture an unauthorised veterinary medicinal product for administration under the cascade;

f

authorisation of an equine stem cell centre;

g

a wholesale dealer’s authorisation;

h

the approval of premises for the supply of POM-VPS or NFA-VPS veterinary medicinal products by a suitably qualified person,

if such an application is refused.

3

A holder of any of the above authorisations, appointment or approvals may appeal against a suspension or compulsory variation in the same way.

4

The appointed person must consider the appeal (but may not consider any new data not available to the Secretary of State at the time of the original decision) and any representations made by the Secretary of State and report in writing, with a recommended course of action, to the Secretary of State.

5

The Secretary of State must then reach a final decision and notify the appellant, together with the reasons for it.