Regulation 201 Amendment of Schedule 24 (packaging information requirements)

Schedule 24 is amended as follows.

In paragraph 7(b), for “published pursuant to Article 65 of the 2001 Directive” substitute “published under regulation 257D”.

In paragraphs 15, 16 and 23, for “marketing authorisation, Article 126a authorisation” substitute “UK marketing authorisation”.

Omit paragraph 18A^f1.

After Part 3 insert—

“PART 4

Outer and immediate packaging: advanced therapy medicinal products

34.

The name of the advanced therapy medicinal product which is the international non-proprietary name, or if none, the common name.

35.

Where appropriate, whether the product is intended for babies, children or adults.

36.

The expiry date in clear terms including the year and month and, if applicable, day.

37.

A description of the active substance, expressed qualitatively and quantitatively.

38.

Where the product contains tissues and cells of human or animal origin—

(a)

a statement that the product contains such cells or tissues; and

(b)

a short description of the cells or tissues and of their specific origin, including the species of animal in cases on non-human origin.

39.

The pharmaceutical form and the contents by weight, volume or number of doses of the product.

40.

A list of excipients, including preservative systems.

41.

The method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated.

42.

A special warning that the product is to be stored out of the sight and reach and children.

43.

Any special warning necessary for the particular product.

44.

Any special storage precautions.

45.

Specific precautions relating to the disposal of the unused product or of waste derived from the product and, where appropriate, reference to any appropriate collection system.

46.

The name and address of the holder of the UK marketing authorisation and, where applicable, the name of the representative appointed by the holder to represent him.

47.

The UK marketing authorisation number.

48.

The manufacturer’s batch number.

49.

The unique donation code assigned by a tissue establishment pursuant to—

(a)

paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990^f2, as regards human gametes and embryos; and

(b)

paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007^f3, as regards other human tissues and cells.

50.

Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.

PART 5

Immediate packaging: blister packs and small packaging (advanced therapy medicinal products)

51.

The information specified in Part 2.

52.

The unique donation code assigned by a tissue establishment pursuant to—

(a)

paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and

(b)

paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells.

53.

Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.”