Paragraph 8B Recalled and counterfeit productsF1

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.

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

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

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.

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

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.

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