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2001/571/EC: Commission Decision of 18 July 2001 on the national provisions notified by Germany in the field of pharmacovigilance (Text with EEA relevance) (notified under document number C(2001) 1974)

2001/571/EC: Commission Decision of 18 July 2001 on the national provisions notified by Germany in the field of pharmacovigilance (Text with EEA relevance) (notified under document number C(2001) 1974)

Decision Β· 2 articles

Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β†—

Article 1

The national provisions on the obligation to report the adverse reactions of medicinal products notified to the Commission by the Federal Republic of Germany by letter of 18 January 2001, and which derogate from Directive 2000/38/EC are rejected.

Article 2

This Decision is addressed to the Federal Republic of Germany. Done at Brussels, 18 July 2001. For the Commission Erkki Liikanen Member of the Commission (1) OJ L 147, 9.6.1975, p. 13. (2) OJ L 139, 10.6.2000, p. 28; corrected in OJ L 249, 4.10.2000, p. 26 and in OJ L 262, 17.10.2000, p. 46. (3) OJ L 214, 24.8.1993, p. 22. (4) OJ L 214, 24.8.1993, p. 1. (5) In the light of the corrigendum in OJ L 262, 10.7.2000, p. 46. (6) BGBl. I p. 3586; as last amended by Article 2 of the Law of 20 July 2000, BGBl. I p. 1045. (7) OJ C 130, 1.5.2001, p. 2.

Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.

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