27. 5. 98 Official Journal of the European Communities L 153/11 COMMISSION REGULATION (EC) No 1069/98 of 26 May 1998 amending Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/93 THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evalutaion of Medicinal Products ('), as amended by Commission Regulation (EC) No 649/98 (3, and in particular Articles 15(4) and 37(4) thereof, Whereas following practical experience in the application of Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/93 (%), appro- priate adaptations should be adopted to the terms of this Regulation; Whereas, it is appropriate to provide for a procedure to be followed in the case that the Commission imposes urgent safety restrictions; Whereas, moreover, it is necessary to introduce some changes to the Annexes to this Regulation; Whereas, the measures provided for in this Regulation are in accordance 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 542/95 is hereby amended as follows: 1. the following paragraph 3 is added to Article 1: ‘3. Where the Commission imposes provisional urgent safety restrictions on the marketing authorisa- () OJ L 214, 24. 8. 1993, p. 1. () OJ L 88, 24. 3. 1998, p. 7. () OJ L 55, 11. 3. 1995, p. 15. tion holder, the marketing authorisation holder shall be obliged to submit an application for a variation taking account of the safety restrictions imposed by the Commission. This application shall be submitted without delay to the Agency for the application of the procedures set out in Articles 6 and 7 of this Regula- tion. This paragraph is without prejudice to Article 18 of Regulation (EEC) No 2309/93.; 2. paragraphs 1 and 2 of Article 8 are replaced by the following: ‘1.  Where the competent Committee delivers an opinion, the Agency shall inform the marketing authorisation holder and the Commission forthwith and shall send to the Commission the amendments to be made to the terms of the marketing authorisa- tion accompanied by the documents set out in Article 9(3) and 31(3) of Regulation (EEC) No 2309/93. 2. Article 9(1) and (2) or Article 31(1) and (2) of Regulation (EEC) No 2309/93 shall apply to the opinion adopted by the competent Committee.’; 3. in Annex I, point A is replaced by the following: ‘A. By derogation, the procedure set out in Articles 6, 7 and 8 of the present Regulation shall apply: — to the minor variations Nos 11, 12, 13, 15 and 16 as referred to below and to minor vari- ations Nos 24 and 25 if the test procedure used is not a physico-chemical method for medicinal products falling within the scope of Council ~ Directive ~ 89/342/EEC (), or 89/381/EEC (), or 90/667/EEC (™), or for medicinal products which had been consid- ered as arising under Part A of the Annex to Regulation (EEC) No 2309/93, — to any minor variation when a specific inspec- tion of a manufacturing site needs to be carried out. () OJ L 142, 25.5.1989, p. 14. (*) OJ L 181, 28.6.1989, p. 44. (*) OJ L 373, 31.12.1990, p. 26.;