Regulation 4 Renewal of certificates

(1)

An application for renewal of a certificate shall be made to the licensing authority in writing in the English language and be signed by the applicant.

(2)

The applicant shall supply four copies of the application.

(3)

Every renewal application shall contain particulars of—

(a)

the holder of the certificate,

(b)

the product to which the certificate relates,

(c)

the certificate held, together with details of any variation thereof and any notification given in accordance with the provisions of the certificate, since the issue of the certificate, or, if it has been renewed, since its last renewal,

(d)

any proposed alterations to the approved dossier in respect of which a provision of the certificate requires an application for variation,

(e)

a summary of all suspected adverse reactions occurring during the test, and

(f)

the reason why the renewal is needed, including up to date particulars of the progress of tests already conducted.

(4)

In the case of an application for the renewal of a certificate issued in respect of an application made in accordance with the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971^f1, the application shall also contain any of the particulars specified in Schedule 1 which have not been submitted before, and particulars of the current labelling, and any leaflet or package insert used for the product.

Annotations

Footnotes

f1: S.I. 1971/973; relevant amending instruments are S.I. 1972/1201 and 1975/681.