The Human Medicines Regulations 2012

PART 1 Manufacturer’s licences

1.  The requirements in paragraphs 2 to 12 apply to a manufacturer’s licence insofar as it relates to the manufacture and assembly of exempt advanced therapy medicinal products.

2.  The licence holder must inform the licensing authority of any adverse reaction or suspected adverse reaction of which the holder is aware within the period of 15 days beginning on the day following the first day on which the holder knew about the reaction.

3.  The licence holder must ensure, if using human cells or tissues in an exempt advanced therapy medicinal product, that the donation, procurement and testing of those cells or tissues is in accordance with Directive 2004/23/EC.

4.  The licence holder must ensure that any human tissue or cell component imported into the United Kingdom and used by the 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—

(a) Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells(1); and

(b) Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells(2).

5.  The licence holder must 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 meets equivalent standards of quality and safety to those laid down in Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components(3).

6.  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 that person must comply with—

(a) the requirements of paragraphs 15, 16, 18 and 19; and

(b) the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive;

as if that person were the holder of a wholesale dealer’s licence.

7.  The licence holder must, 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.

8.  The licence holder must 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 delivery to the establishment where the product is used.

9.  The licence holder must, subject to paragraph 27 of Schedule 4, keep the data referred to in paragraph 8 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product.

10.  The licence holder must secure that the data referred to in paragraph 8 will, in the event that—

(a) the licence is suspended, revoked or withdrawn; or

(b) 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 paragraph 9 or such longer period as may be required pursuant to paragraph 27 of Schedule 4.

11.  The licence holder must, where an exempt advanced therapy medicinal product contains human cells or tissues, ensure that the traceability system established in accordance with paragraph 8 is complementary to and compatible with the requirements laid down in—

(a) Articles 8 and 14 of Directive 2004/23/EC as regards human cells and tissues other than blood cells, and

(b) as regards human blood cells, Articles 14 and 24 of Directive 2002/98/EC.

12.  The licence holder must not import or export any exempt advanced therapy medicinal product.

(1)

OJ No L 38, 9.2.2006, p. 40.

(2)

OJ No L 294, 25.10.2006, p. 32.

(3)

OJ No L 91, 30.3.2004, p. 25, as amended by Commission Directive 2011/38/EU, OJ No L 94, 12.4.2011, p. 28.