Regulation 266 Language requirements etc

(1)

Information given in accordance with the requirements of this Part must be given in English unless either or both of paragraphs (2) and (3) applies.

(2)

This paragraph applies in the case of a medicinal product that has been designated as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products M1 where—

(a)

any information specified in paragraph (1) is given in a language of an EEA State other than English; and

(b)

the licensing authority accedes to a reasoned request that the information need not be given in English.

(3)

This paragraph applies in the case of a product for which the licensing authority grants an Article 126a authorisation where the licensing authority decides that the information need not be given in English.

(4)

In a case where paragraph (5) applies, the licensing authority may grant either or both of—

(a)

an exemption from the obligation that certain particulars should appear on the outer and immediate packaging and in the package leaflet of the medicinal product in accordance with this Part; and

(b)

a full or partial exemption from the obligation that the information included on the outer and immediate packaging and in the package leaflet for the product must be given in English in accordance with paragraph (1).

(5)

This paragraph applies—

(a)

when a medicinal product is not intended to be delivered directly to the patient; or

(b)

where there are severe problems in respect of the availability of the medicinal product.

(6)

The licensing authority may make the grant of an exemption in accordance with paragraph (4) subject to measures that it considers necessary to safeguard human health

(7)

Information given in English in accordance with this regulation may be given in several languages in addition to English, provided that the same particulars appear in all the languages used.

Annotations

Marginal citations

M1: OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.