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

Regulation 3(1)

SCHEDULE 1 Requirement that holders of manufacturer’s licences comply with certain obligations in relation to the manufacture and assembly of exempt advanced therapy medicinal products

A holder of a manufacturer’s licence must—

(a) comply with the principles and guidelines of good manufacturing practice;

(b) maintain such staff, premises, equipment and facilities—

(i) as are necessary for such stages of the manufacture and assembly of exempt advanced therapy medicinal products as are undertaken by the manufacturer’s licence holder in accordance with the requirements of the manufacturer’s licence, and

(ii) for the handling, control, storage and distribution of the exempt advanced therapy medicinal products which are handled, stored and distributed under the licence, as are necessary to maintain the quality of those products;

(c) inform the licensing authority—

(i) before making any material alteration to the premises or facilities used under the manufacturer’s licence, or in the operations for which they are used,

(ii) of any change that manufacturer’s licence holder proposes to make to any personnel named in the licence as responsible for quality control of the exempt advanced therapy medicinal products being manufactured or assembled by the manufacturer’s licence holder, and

(iii) of any adverse reaction or suspected adverse reaction of which the holder is aware within 15 days of becoming aware of it;

(d) for the purpose of enabling the licensing authority to ascertain whether there are any grounds—

(i) for suspending, revoking or varying any licence granted under Part II of the Act, or

(ii) suspending or terminating any licence in accordance with the provisions of Part II of the Act,

permit, and provide all necessary facilities to enable, any person duly authorised in writing by the licensing authority, on production if required of the relevant credentials, to carry out such inspection or to take such samples or copies, in relation to things belonging to, or any business carried on by, the holder of the licence, as such person would have the right to carry out or take under the Act for the purpose of verifying any statement contained in an application for a licence;

(e) ensure that any arrangements that are made with any person for the control, storage and distribution of the exempt advanced therapy medicinal products are adequate to maintain the quality of those products;

(f) not carry out any manufacture or assembly of exempt advanced therapy medicinal products other than—

(i) the manufacture or assembly of those classes of exempt advanced therapy medicinal product specified in the licence, and

(ii) at the premises specified in the licence;

(g) not use any premises for the handling, control, storage or distribution of exempt advanced therapy medicinal products other than those specified in the manufacturer’s licence as approved by the licensing authority for that purpose, or approved by the licensing authority for that purpose from time to time;

(h) if using human cells or tissues in an exempt advanced therapy medicinal product, ensure that the donation, procurement and testing of those cells or tissues is in accordance with Directive 2004/23/EC(1);

(i) ensure that any human tissue or cell component imported into the United Kingdom and used by the manufacturer’s licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those laid down in Commission Directives 2006/17/EC(2) and 2006/86/EC(3);

(j) ensure that any blood or blood component imported into the United Kingdom and used by the manufacturer’s licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those laid down in Commission Directive 2004/33/EC(4), implementing Directive 2002/98/EC(5) of the European Parliament and of the Council as regards certain technical requirements for blood and blood components;

(k) where the holder of a manufacturer’s licence distributes by way of wholesale dealing any exempt advanced therapy medicinal product manufactured or assembled pursuant to the licence, comply with the requirements of sub-paragraphs (e), (k), (o) and (p) of Schedule 3 as if that person were the holder of a wholesale dealer’s licence;

(l) not solicit any order for an exempt advanced therapy medicinal product by—

(i) advertising or making any representation relating to an exempt advanced therapy medicinal product with a view to the advertisement or representation being seen generally by the public in the United Kingdom,

(ii) advertising an exempt advanced therapy medicinal product by means of any catalogue or circular letter,

or otherwise;

(m) at the written request of the licensing authority set up a risk management system designed to identify, characterise, prevent or minimise risks related to the exempt advanced therapy medicinal product;

(n) establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivered to the establishment where the product is used;

(o) subject to paragraph 1(j) of Schedule 2, keep the data referred to in sub-paragraph (n) for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product;

(p) secure that the data referred to in sub-paragraph (n) will, in the event that—

(i) the licence is suspended, revoked or withdrawn, or

(ii) the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a manufacturer’s licence for the period described in sub-paragraph (o) or such longer period as may be required pursuant to paragraph 1(j) of Schedule 2;

(q) where an exempt advanced therapy medicinal product contains human cells or tissues, ensure that the traceability system established in accordance with subparagraph (n) is complementary to and compatible with the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC(6) as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC as regards human blood cells; and

(r) not import or export any exempt advanced therapy medicinal product.

(1)

OJ No. L 102, 7.4.2004, p.48.

(2)

OJ No. L 38, 9.2.2006, p.40.

(3)

OJ No. L 294, 25.10.2006, p.32.

(4)

OJ No. L 91, 30.3.2004, p.25.

(5)

OJ No. L 33, 8.2.2003, p.30.

(6)

OJ No. L 102, 7.4.2004, p.48.