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Expert Review of Pharmacoeconomics & Outcomes Research Volume 2, 2002 - Issue 1
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Review

Toward new legislation on drugs in Europe

Silvio Garattini Silvio Garattini, Istituto di Ricerche Farmacologiche ‘Mario Negri’, Via Eritrea 62, 20157 Milano, Italy. [email protected]
&
Vittorio Bertele’ Vittorio Bertele’, Istituto di Ricerche Farmacologiche ‘Mario Negri’, Via Eritrea 62, 20157 Milano, Italy. [email protected]
Pages 51-56 | Published online: 09 Jan 2014

References

  • 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. Official Journal of the European Communities No L 214 of 24.08.93 (1993).
  • •This is the regulation that established the EMEA.
  • Garattini S, Bertele' V. Policing the European pharmaceutical market's priorities. Eur. j Clin. Pharmacol. 56, 441–443 (2000).
  • Garattini S, Bertelé V. Adjusting Europe's drug regulation to public health needs. Lancet 358,64–67 (2001).
  • •This includes the authors' suggestions to enable the European regulatory authority to fulfil its commitment to the defence of public health.
  • Council Conclusions of 29 June 2000 on Medicinal Products and Public Health. Official Journal of the European Communities, C 218/04, 10–11 (2000).
  • Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Safety 20(2), 109–117 (1999).
  • The European Agency for the Evaluation of Medicinal Products. Work Program 2000-2001. EMEA, London, 33 (2001).
  • Anonymous. French complete reimbursement review. Scrip 2645, 6 (2001).
  • Commission of the European Communities. Proposal for a Regulation of the European Parliament and of the Council laying down Community rocedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. http:// pharmacos.eudra.org/F2/review/doc/ finaltext/011126-COM_2001_404- EN.pdf

Websites

  • ••This includes the EC proposal for amendments to the regulatory system and procedures, with an annotated guide.
  • Commission of the European Communities. Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. http:// pharmacos.eudra.org/F2/review/doc/ finaltext/011126-COM_2001_404-EN.pdf
  • ••This includes the EC proposal ofamendments to the community code relating to medicines for human use, with an annotated guide.
  • The World Medical Association, Inc. The Declaration of Helsinki (2000). www.wma.net

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