The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

Regulation 8

SCHEDULE 5 Amendments to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Amendment of regulation 1

1.  In regulation 1(2) (citation, commencement and interpretation)—

(a) after the definition of “the Act”, insert the following definitions—

““advanced therapy medicinal product” has the meaning set out in paragraph 1(a) of Article 2 of the ATMP Regulation”;

““the ATMP Regulation” means Regulation (EC) No. 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products;”;

(b) in the definition of “the 2001 Directive”(1), for “and the Paediatric Regulation” substitute—

“,

the Paediatric Regulation,

the ATMP Regulation,

Directive 2008/29/EC of the European Parliament and of the Council,

Directive 2009/53/EC of the European Parliament and of the Council, and

Commission Directive 2009/120/EC;”;

(c) in the definition of “Regulation (EC) No. 726/2004”(2), after “as amended by the Paediatric Regulation” insert “and the ATMP Regulation”; and

(d) in the definition of “the relevant Community provisions”(3)—

(i) delete the word “and”, and

(ii) after “the Paediatric Regulation;” insert—

“and the ATMP Regulation;”.

Amendment of Schedule 1

2.  In Schedule 1 (exemptions and exceptions from the provisions of regulation 3), in paragraph 2(b), delete “, price list ”.

Amendment of Schedule 3

3.—(1) Schedule 3 (offences, penalties etc) shall be amended as follows.

(2) After paragraph 10A(4), insert the following paragraphs—

“10B.— (1) A holder of a Community marketing authorization for an advanced therapy medicinal product who fails to—

(a) submit an additional report evaluating the effectiveness of a risk management system and the results of studies within 21 days of receipt of a request made under sub-paragraph (2) of Article 14(2) of the ATMP Regulation or such longer period as the European Medicines Agency may specify; or

(b) include an evaluation of the effectiveness of a risk management system or the results of any study performed pursuant to sub-paragraph (3) of Article 14(2) of the ATMP Regulation,

shall be guilty of an offence.

(2) Any relevant person who fails—

(a) to establish a traceability system in accordance with the requirements set out in Article 15(1) of the ATMP Regulation;

(b) where the product contains human cells or tissues, to ensure that the traceability system is complementary to and compatible with, the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC(5) as regards blood cells; or

(c) to keep the data to which the traceability system relates in accordance with the requirements set out in Article 15(4) of the ATMP Regulation,

shall be guilty of an offence.

(3) In sub-paragraph (2), “relevant person” means a person—

(a) who is the holder of a Community marketing authorization for an advanced therapy medicinal product, or

(b) whose Community marketing authorization for an advanced therapy medicinal product has been suspended, revoked or withdrawn.”.

(3) In paragraphs 11 and 12(6), after “Directive” (in each place that it occurs) insert “, of Chapter 4 of the ATMP Regulation”.

(4) After paragraph 13B(7), insert the following paragraphs—

“13C.— (1) Subject to sub-paragraphs (2) and (3), any person who is or, immediately before its revocation or suspension, was the holder of a marketing authorisation relating to an advanced therapy medicinal product who fails to—

(a) keep the data referred to in Article 15(1) of the ATMP Regulation for 30 years after the expiry date of the product or such longer period as may be required by the Commission; or

(b) transfer the data referred to in Article 15(1) to the European Medicines Agency established by Regulation (EC) No. 726/2004 in the event of that person’s bankruptcy or liquidation,

shall be guilty of an offence.

(2) Sub-paragraph (1)(b) does not apply if—

(a) the person is bankrupt or in liquidation and has transferred the data to another person; or

(b) the period for which the person was required to keep the data pursuant to sub-paragraph (1)(a) has expired.”.

(5) In paragraph 15(8) (miscellaneous), for “or 10A” substitute “, 10A or 10B”.

Amendment of Schedule 6

4.  In Schedule 6 (transitional provisions), after paragraph 5 insert the following paragraph—

“6.— (1) Subject to sub-paragraph (2), these Regulations shall not apply to advanced therapy medicinal products which were legally on the European Union market on 30^th December 2008 until 30th December 2011.

(2) These Regulations shall not apply to advanced therapy medicinal products which are tissue engineered products which were legally on the Community market in accordance with national or Community legislation on 30th December 2008 until 30th December 2012.”.

(1)

The definition of “the 2001 Directive” was inserted by S.I. 2002/236 and amended by S.I. 2003/2321, 2004/3224, 2005/50, 2005/2759 and 2008/3097.

(2)

The definition of “the Regulation (EC) No 726/2004” was inserted by S.I. 2004/3224 and amended by S.I. 2008/3097.

(3)

The definition of “the relevant Community provisions” was substituted by S.I. 2002/236 and amended by S.I. 2003/2321, 2004/3224, 2005/2759 and 2008/3097.

(4)

Paragraph 10A was inserted by S.I. 2005/1710.

(5)

OJ No. L33, 8.2.2003, p.30.

(6)

Paragraph 12 was amended by S.I. 1998/3105 and S.I. 2002/236.

(7)

Paragraph 13B was inserted by S.I.2008/3097.

(8)

Paragraph 15 was amended by S.I.2005/1710.