L 202/46 Official Journal of the European Communities 27.7.2001 COMMISSION DECISION of 18 July 2001 on the national provisions notified by Germany in the field of pharmacovigilance (notified under document number C(2001) 1974) (Only the German text is authentic) (Text with EEA relevance) (2001/571/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, and in particular Article 95(6) thereof, Whereas: I. THE FACTS 1. Relevant Community legislation The current Community provisions on pharmacovigi- lance, ie. the supervision of medicinal products once they have been authorised, are contained in Chapter Va (Article 29a to 29i) of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products ('), as last amended by Directive 2000/38/EC (). Chapter Va was added to Directive 75/319/EEC by Directive 93/39/EEC (?). The provisions on reporting adverse reactions which are relevant for this notification are contained primarily in Article 29d. Pursuant to Article 29d(1) the person responsible for placing the medicinal product on the market shall be required to recall and to report all suspected serious adverse reactions which are brought to his attention by a health-care professional immediately to the competent authority, and in any case within 15 days at the latest. Pursuant to Article 29d(2) records shall be maintained of all other suspected adverse reac- tions and shall be sumitted to the authorities at regular intervals. In Article 29i the Commission is authorised to update the provisions of Chapter Va, in accordance with the procedures laid down in Article 37a of Directive 75/319/EEC, to take account of scientific and technical progress. In the light of new knowledge in the field of pharmaco- vigilance, continued efforts to achieve international harmonisation of pharmacovigilance data and techno- logical developments in electronic data collection and transmission, the Commission has made use of the authorisation contained in Article 29i and has amended () O] L 147, 9.6.1975, p. 13. () OJ L 139, 10.6.2000, p. 28; corrected in O] L 249, 4.10.2000, p. 26 and in O] L 262, 17.10.2000, p. 46. () O] L 214, 24.8.1993, p. 22. several points of the abovementioned provisions by Directive 2000/38/EC. In so doing the Commission took as a base a high level of protection pursuant to Article 95(3) of the EC Treaty and in particular it has taken account of all new scientifically based developments. For the sake of legal clarity and irrespective of the scope of each amendment, the individual provisions have been entirely redrafted. The main objective of Directive 2000/38/EC is to remodel the pharmacovigilance systems, which to date have primarily been paper-based and organised at national level, into a Community-wide electronic data system. All pharmacovigilance information will be entered in this and then automatically stored in a data bank, to be set up by the European Agency for the Evaluation of Medicinal Products (hereafter referred to as the EMEA) established by 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 Evaluation of Medicinal Products (*). From there the data can be retrieved at any time by the member States, the Commission and the EMEA itself. This electronic network will be based on new knowledge and advances in the field of information technology, thereby making the collection and exchange of data more efficient, relieving the marketing authorisation holders of unnecessary — reporting obligations and  generally improving the surveillance of medicinal products in the Community. The central provisions on reporting adverse reactions are contained in the revised version of Article 29d(2) and (4) from the year 2000. Pursuant to the new version of Article 29d(2), the marketing authorisation holder is required to record and to report all suspected serious adverse reactions which are brought to his attention by a health-care professional immediately to the competent authority of the Member State, in whose territory the incident occurred, and in no case later than 15 days after () O] L 214, 24.8.1993, p. 1.