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

Amendment of Schedule 3

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

(2) After paragraph 10A(1), 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(2) 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(b) whose Community marketing authorization for an advanced therapy medicinal product has been suspended, revoked or withdrawn.”.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(3), after “Directive” (in each place that it occurs) insert “, of Chapter 4 of the ATMP Regulation”.

(4) After paragraph 13B(4), 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(5) (miscellaneous), for “or 10A” substitute “, 10A or 10B”.

(1)

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

(2)

OJ No. L33, 8.2.2003, p.30.

(3)

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

(4)

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

(5)

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