Regulation 7 Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

(1)

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 M1 shall be amended as follows.

(2)

In regulation 1 (citation, commencement and interpretation)—

(a)

in paragraph (2)—

(i)

in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”, and

(ii)

in the definition of “the relevant Community provisions”M2—

(aa)

omit “Regulation (EC) No. 541/95, as amended” and “Regulation (EC) No. 542/95, as amended”, and

(bb)

after “Regulation (EC) No. 847/2000” insert the following entries—

“Regulation (EC) No. 1084/2003 M3, and Regulation (EC) No. 1085/2003 M4;”; and

(b)

in paragraph (4), after sub-paragraph (b) insert the following sub-paragraph—

“(bb)
any reference in these Regulations to an application for the variation of a marketing authorization includes a reference to a notification of such a variation, and any reference to an applicant for a variation to a marketing authorization includes a reference to a person submitting such a notification; and”.

(3)

After regulation 6 (revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products), insert the following regulation—

“Urgent safety restrictions
6A
(1)
The licensing authority may, subject to and in accordance with the relevant Community provisions, impose an urgent safety restriction M5 on the holder of a United Kingdom marketing authorization.
(2)
Where the licensing authority imposes an urgent safety restriction in accordance with paragraph (1), the holder of the marketing authorization shall—
(a)
implement the restriction within a period specified by the licensing authority; and
(b)
apply to vary the authorization so as to take account of that safety restriction immediately and in any event not later than 15 days after the restriction was imposed.”.

(4)

In Schedule 3 (offences, penalties etc) M6—

(a)

after paragraph 3 insert the following paragraph—

“
3A
Any person who is the holder of a marketing authorization who fails to implement an urgent safety restriction imposed on him by the licensing authority under regulation 6A or by the European Commission under Commission Regulation (EC) No. 1085/2003 shall be guilty of an offence.”; and

(b)

in paragraph 6, in sub-paragraph (c), for “paragraph D of Part 2 of Annex I to the 2001 Directive” substitute “ paragraphs 3.2(9), 3.2.1.2(c) and 3.2.2.4(c) of Part I of Annex I to the 2001 Directive ”.

Annotations

Marginal citations

M1: S.I. 1994/3144; as amended by S.I. 1998/3105, 2000/292, 2001/795, 2002/236, 2002/542 and 2003/1618.
M2: The definition of “the relevant Community provisions” was substituted by regulation 8(a)(ii) of S.I. 2002/236.
M3: OJ No. L159, 27.6.2003, p.1.
M4: OJ No. L159, 27.6.2003, p.24.
M5: Expressions used in the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 have the same meaning as in the relevant Community provisions (by virtue of regulation 1(5)); for the definition of “urgent safety restriction” see article 3(5) of Regulation (EC) No. 1084/2003.
M6: Schedule 3 was amended by S.I. 1998/3105, 2000/292 and 2002/236.