Article 4
Unexpected, non-serious, suspected adverse reactions which, according to the assessment carried out by the holder of the marketing authorization, can be attributed to the medicinal product and requiring a change to the summary of products characteristics referred to in Article 4 (9) second paragraph of Council Directive 65/65/EEC (2), as last amended by Directive 93/39/EEC (3), and in Article 5 (9) second paragraph of Council Directive 81/851/EEC (4), as last amended by Directive 93/40/EEC, shall be dealt with in accordance with Commission Regulation (EC) No 542/95 of 10 March 1995, as last amended by Directive 93/40/EEC (5), concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93 (6), and with Commission Regulation (EEC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State (7).