Regulation 88 New paragraphs 8A and 8B

After paragraph 8 insert—

“Good manufacturing practice

8A.

(1)

A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with this paragraph, whether the manufacturing is performed by the holder or another person.

(2)

The manufacturing operations must be conducted in accordance with a written methodology, to be known as the “pharmaceutical quality system” or “PQS”.

(3)

The PQS must be—

(a)

clear;

(b)

systematically reviewed from time to time in the light of experience; and

(c)

capable of consistently manufacturing veterinary medicinal products which are of the required quality and which meet the requirements of the relevant marketing authorisation.

(4)

The critical steps of the manufacturing process set out in the PQS must be validated.

(5)

Any significant amendments to the PQS must be validated.

(6)

The PQS must provide for—

(a)

appropriately qualified and trained personnel;

(b)

adequate premises and space;

(c)

suitable equipment and access to services;

(d)

suitable materials, containers and labelling;

(e)

relevant procedures and instructions;

(f)

suitable storage and transport;

(g)

investigation into complaints and defects.

(7)

The PQS must provide for any significant deviations from its provisions to be—

(a)

fully recorded, and

(b)

investigated, with appropriate corrective and preventative action implemented.

(8)

The holder of a manufacturing authorisation must ensure that records of the manufacturing process, including distribution, are kept in a comprehensible and accessible form until the later of—

(a)

the date which is five years after the date on which the veterinary medicinal product is placed on the market;

(b)

the date which is one year after the expiry date of the batch of veterinary medicinal product.

(9)

In this paragraph, a process (or part of a process) is “validated” if scientific evidence is assembled which demonstrates that it is capable of consistently delivering expected results.

Recalled and counterfeit products

8B.

(1)

The holder of a manufacturing authorisation must comply with any requirement by the Secretary of State to recall a veterinary medicinal product and must record the details of the recall operation.

(2)

The holder of a manufacturing authorisation must record any veterinary medicinal product which is—

(a)

recalled (whether or not the holder physically receives the recalled product); or

(b)

discovered to be counterfeit.

(3)

Where any veterinary medicinal product is recalled and physically received, the qualified person (manufacture) must assess the recalled product in order to determine whether—

(a)

the product has been stored (including during transport) in accordance with the summary of product characteristics;

(b)

the product is a genuine product and not counterfeit.

(4)

Where the qualified person (manufacture) determines that a recalled veterinary medicinal product does not satisfy sub-paragraph (3)(a) or (b), or where it is not possible for the qualified person (manufacture) to determine whether the product does so, the product may not be re-sold.

(5)

The qualified person (manufacture) must record any assessment and determination made under sub-paragraphs (3) and (4).

(6)

Any veterinary medicinal products which may not be re-sold must be identified, held separately and destroyed and the holder of a manufacturing authorisation must develop a suitable procedure to set out the steps to be taken in accordance with this sub-paragraph.

(7)

The holder of a manufacturing authorisation must keep any information recorded under this paragraph for five years.”.