Regulation 85 Amendment to paragraph 5

In paragraph 5 (suspension, variation or revocation of authorisation)—

(a)

in sub-paragraph (1)—

(i)

after paragraph (c) omit “or”;

(ii)

at the end insert—

“(e)

has failed to carry out the activity specified in the authorisation for a period of five years or more; or

(f)

has not paid any fee required under these Regulations”;

(b)

for sub-paragraph (2) substitute—

“(2)

The Secretary of State may also suspend, vary or revoke the authorisation on being satisfied that the qualified person (manufacture), the person responsible for quality control or the person with responsibility for production is not fulfilling that person’s duties under these Regulations.

(3)

In particular, the Secretary of State may—

(a)

suspend the manufacture or import of veterinary medicinal products;

(b)

suspend, revoke or vary the manufacturing authorisation for one or more pharmaceutical forms;

(c)

suspend, revoke or vary the manufacturing authorisation for one or more activities in one or more manufacturing sites.”;

(c)

in the heading for “Suspension, variation or revocation” substitute “Suspension, revocation etc”.