Regulation 4 Insertion of Schedules 7 and 8 into the principal Regulations

After Schedule 6 to the principal Regulations, there shall be inserted the following Schedules—

“SCHEDULE 7

STANDARD LABELLING REQUIREMENTS FOR CONTAINERS AND PACKAGES OF MEDICINAL PRODUCTS FOR HUMAN USE

Regulation 4A(1)

1

The name of the product followed, where the product contains one active ingredient and its name is an invented name, by the common name.

2

A statement of the active ingredients of the product expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using the common names of the ingredients.

3

The pharmaceutical form of the product.

4

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

5

A list of excipients known to have a recognised action or effect. In relation to products which are injectable or are topical or eye preparations, all excipients.

6

The method and, if necessary, the route of administration of the product.

7

A special warning that the product must be stored out of reach of children.

8

Any special warning required by the product licence for the product concerned.

9

The expiry date of the product (stating the month and year) in clear terms.

10

Any special storage precautions for the product.

11

Any special precautions for the disposal of any unused products or waste materials derived from such products.

12

The name of the holder of the product licence of the product.

13

The address of the holder of the product licence of the product.

14

Any product licence number as allocated by the licensing authority which relates to the product preceded by the letters “PL” in capital letters or other abbreviation of the expression “product licence”.

15

The manufacturer’s batch reference.

16

Where a product is intended for self-medication, any instruction on the use of the product.

SCHEDULE 8

STANDARD LABELLING REQUIREMENTS FOR CONTAINERS AND PACKAGES OF RADIOPHARMACEUTICALS FOR HUMAN USE

Regulation 4B

1

The container and the package shall be labelled in accordance with the 1985 Edition (as amended in 1990) of the Regulations for the Safe Transport of Radioactive Materials recommended by the International Atomic Energy Agency.

2

The labelling on the shielding shall explain in full the codings used on the vial and shall indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or for liquids, the number of millilitres in the container.

3

The vial shall be labelled to show—

(a)

the name or code of the medicinal product, including the name or chemical symbol of the radionuclide;

(b)

the international symbol for radioactivity;

(c)

the name of the manufacturer; and

(d)

the amount of radioactivity as specified in paragraph 2 above.”.