Regulation 107 Validity of certificate of registration

(1)

Subject to the following paragraphs, a certificate of registration remains in force—

(a)

for an initial period of five years beginning with the date on which it is granted; and

(b)

if the authorisation is renewed under regulation 108 for an unlimited period after its renewal.

(2)

The licensing authority may, on the first application for renewal of a certificate, determine on grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, that it should be necessary for the holder to make one further application for renewal.

(3)

In that event, the certificate remains in force—

(a)

for a further period of five years beginning with the date on which it is first renewed; and

(b)

if the authorisation is further renewed under regulation 108 for an unlimited period after its further renewal.

(4)

If an application for the renewal or further renewal of a certificate is made in accordance with regulation 108 the certificate remains in force until the licensing authority notifies the applicant of its decision on the application.

(5)

This regulation is subject to—

(a)

regulation 109 (failure to place on the market etc); and

(b)

regulation 110 (revocation etc of certificate of registration).