SCHEDULE 3Classification and supply, wholesale dealers and sheep dip
PART 2Requirements for a wholesale dealer’s authorisation
Application
16.
An application for a wholesale dealer’s authorisation must be made to the Secretary of State.
Time limits
17.
The Secretary of State must process an application for a wholesale dealer’s authorisation within 90 days of receiving it.
Granting the authorisation
18.
(1)
The Secretary of State must grant a wholesale dealer’s authorisation if he is satisfied that this paragraph is complied with.
(2)
The authorised site must be—
(a)
weatherproof;
(b)
secure and lockable;
(c)
clean; and
(d)
free from contaminants.
(3)
If the veterinary medicinal products covered by the authorisation are subject to specific storage conditions, the site must be capable of fulfilling those requirements.
(4)
The authorisation holder must—
(a)
have at his disposal the services of technically competent staff; and
(b)
have an effective emergency recall plan.
The authorisation
19.
(1)
The wholesale dealer’s authorisation must specify—
(a)
the types of veterinary medicinal products and pharmaceutical forms that may be dealt in;
(b)
the place where they are to be stored;
(c)
the name and address of the person holding the authorisation;
(d)
the address of the premises to which it relates;
(e)
the name of the qualified person nominated to act under the Guidelines on Good Distribution Practice under paragraph 22.
(2)
It may cover more than one site.
(3)
It lapses if the holder does not deal in veterinary medicinal products for five years.
Suspension or revocation of the authorisation
20.
The Secretary of State may suspend or revoke a wholesale dealer’s authorisation if the holder—
(a)
has not complied with these Regulations; or
(b)
no longer has suitable premises or equipment.
Appeals
21.
(1)
A person may appeal against a refusal, suspension or revocation of a wholesale dealer’s authorisation to a person appointed for the purpose by the Secretary of State.
(2)
The appointed person must consider the appeal and report in writing to the Secretary of State.
(3)
The Secretary of State must give written notification of his final determination and the reasons for it.
Duties on the holder of a wholesale dealer’s authorisation
22.
(1)
The holder of a wholesale dealer’s authorisation must store veterinary medicinal products in accordance with the terms of the marketing authorisation for each product.
(2)
(3)
He must carry out a detailed stock audit at least once a year.
(4)
He must supply information and samples to the Secretary of State on demand.
(5)
He must notify the Secretary of State if there are any changes to the information held by him.
(6)
It is an offence to fail to comply with this paragraph.