Particulars to be contained in or to accompany renewal applications4

1

Every renewal application shall contain or be accompanied by particulars of—

a

the holder of the licence or certificate in respect of which the renewal application is made,

b

the product or class of products to which that licence or certificate relates,

c

the licence or certificate held, any variation thereof, and any notification to the licensing authority in accordance with the provisions of the licence or certificate, made since the grant of the licence or issue of the certificate as the case may be, or, if such licence or certificate has been renewed, since the date of the last renewal, and

d

any material changes, other than those submitted in accordance with sub-paragraph (c) above, in the information submitted in the application for the grant of the licence or issue of the certificate as the case may be, or, if such licence or certificate has been renewed, any such changes since the date of the last renewal.

2

In the case of the renewal of a certificate, every renewal application shall be accompanied by up to date particulars of the progress of the medicinal test on animals to which the certificate relates.