3. 6.98 Official Journal of the European Communities L 159/31 COMMISSION REGULATION (EC) No 1146/98 of 2 June 1998 amending Regulation (EC) No 541/95 concerning the examination of variations in the terms of a marketing authorisation granted by a competent authority of a Member State THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 75/319/EEC of 20 May 1975, on the approximation of provisions laid down by law, regulations or administrative action relating to medicinal products ('), as last amended by Directive 93/39/EEC (%), and in particular Article 15 thereof, Having regard to Council Directive 81/851/EEC of 28 September 1981, on the approximation of legislation of the Member States relating to veterinary medicinal products (°), as last amended by Directive 93/40/EEC (%), and in particular Article 23 thereof, Whereas, following practical experience in the application of Commission Regulation (EC) No 541/95 () appropriate provisions should be made to the terms of this Regula- tion; Whereas it is appropriate to provide for a procedure to be followed in the case where national competent authority imposes urgent safety restrictions; Whereas, moreover, it is necessary to simplify the notifi- cation procedure for minor variations and to introduce some changes to the annexes to this Regulation; Whereas, the provisions of this Regulation are in ac- cordance with the opinion of the Standing Committee on Medicinal Products for Human Use and the Standing Committee on Veterinary Medicinal Products, HAS ADOPTED THIS REGULATION: Article 1 Regulation (EC) No 541/95 is amended as follows: 1. In Article 1 the following paragraph 3 is added: ‘3. Where national competent authorities impose urgent provisional safety restrictions on the marketing () OJ L 147, 9. 6. 1975, p. 13. () OJ L 214, 24. 8. 1993, p. 22. () OJ L 317, 6. 11. 1981, p. 1. () OF L 214, 24. 8. 1993, p. 31. () OJ L 55, 11. 3. 1995, p. 7. authorisation holder, the marketing authorisation holder shall be obliged to submit an application for a variation taking account of the safety restrictions imposed by the national authorities. This application shall be submitted without delay to the national competent authorities concerned for the application of the procedures set out in Articles 6 and 7 of this Regu- lation. This paragraph is without prejudice to Article 15a of Directive 75/319/EEC and Article 23a of Direc- tive 81/851/EEC’. . In Article 4, paragraph 2 is replaced by the following text: ‘2. The reference Member State shall forthwith inform all other concerned Member States about the date of the start of the procedure. The reference Member State shall also inform the marketing author- isation holder(s) about the date of the start of the pro- cedure’. . After Article 7, Article 7a and Article 7b are added: ‘Article 7a Because of the specificities inherent in the manufac- turing of human influenza vaccines, the following dispositions are applicable: 1. Within 30 days following the date of the start of the procedure, the national competent authorities of the reference Member State shall prepare an assessment report on a pharmaceutical dossier and a draft de- cision which shall be addressed to the other national competent authorities concerned. 2. Within that period, the competent authority of the reference Member State may send the marketing authorisation holder a single request for information in addition to that already supplied pursuant to Article 6. It shall inform the other competent authorities concerned. 3. Within 12 days of receipt of the draft decision and the assessment report, the other competent national authorities concerned shall accept this draft decision and inform the competent national authority of the reference Member State to this effect.