Regulation 3 Insertion of regulations 4A, 4B, 4C, 4D and 4E into the principal Regulations

After regulation 4 of the principal Regulations there shall be inserted the following regulations—

“Standard labelling requirements for containers and packages for medicinal products for human use

4A

(1)

Except where paragraph (2) or (3) of this regulation applies, containers and packages of relevant medicinal products shall be labelled to show the particulars set out in Schedule 7 to these regulations.

(2)

Where the container of a relevant medicinal product is not a blister pack and is too small to be labelled to show all of the particulars set out in Schedule 7 to these regulations, it shall nevertheless be labelled to show the particulars set out in paragraphs 1, 4, 6, 9 and 15 of that Schedule.

(3)

Where the container of a relevant medicinal product is a blister pack and is enclosed within a package which complies with paragraph (1) of this regulation, that container shall be labelled to show the particulars set out in paragraphs 1, 9, 12 and 15 of Schedule 7 to these regulations.

(4)

Containers and packages of relevant medicinal products may be labelled to show—

(a)

a symbol or pictogram designed to clarify the particulars set out in Schedule 7 to these regulations;

(b)

other information compatible with the summary of product characteristics which is useful for health education,

to the exclusion of any element of a promotional nature.

(5)

In sub-paragraph (b) of paragraph (4) of this regulation, “summary of product characteristics” means the information required to accompany any application for a product licence by virtue of Article 4a of Directive 65/65/EEC which was inserted by Article 1(2) of Directive 83/570/EEC^f1 and amended by Article 1(1) and (4) of Directive 89/341/EEC, which expression shall include, where there no such information accompanied the application—

(a)

the data sheet, if there is one; or

(b)

if there is no data sheet, the information which would be required to accompany an application for a product licence by virtue of Article 4a of Directive 65/65/EEC.

Standard labelling requirements for containers and packages of radiopharmaceuticals for human use

4B

Containers and packages of products to which Chapters II to V of the 1965 Directive applies which are radiopharmaceuticals shall be labelled to show the particulars set out in Schedule 8 to these regulations in addition to any particulars required by any other provision of these regulations.

General provisions relating to labelling of medicinal products for human use

4C

(1)

All labelling of containers and packages of relevant medicinal products shall be—

(a)

legible and indelible;

(b)

comprehensible; and

(b)

either in the English language only or in English and in one or more other languages provided that the same particulars appear in all the languages used.

(2)

Where the holder of a product licence for a relevant medicinal product proposes to alter the labelling relating to it in any respect as to which regulation 4A of these regulations imposes a requirement (not being an application made in connection with the grant or variation of a product licence), he shall notify the licensing authority in writing of such proposed alteration and, unless the licensing authority has earlier notified him that it does not approve the altered labelling, he may, after the expiry of 90 days from the date of notification by him, supply the product, or cause the product to be supplied, with the altered labelling.

Special requirements for the labelling of the name of medicinal products for human use

4D

(1)

In any case where—

(a)

a relevant medicinal product is available in more than one pharmaceutical form or in more than one strength; and

(b)

the name of that product does not include the pharmaceutical form and the strength of the product,

in a place where the label prominently shows the name of the product there shall be added immediately after the name, in the same style and size of letters as the name, a statement of the pharmaceutical form or strength of that product; and in this paragraph “strength” means the suitability of the product for a baby, child or adult.

(2)

The requirement for a container or package of a relevant medicinal product to be labelled to show its name is not met by the container or package being labelled to show an invented name which is liable to be confused with the common name.

Application of particular regulations

4E

Regulations 5 to 8, 11, 12, 14D and E, 15 to 17, 18(2) and 19 of these regulations shall not apply in relation to relevant medicinal products.”.