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Directive No. 2004/27/EC of the European Parliament and of the Council of 31 March 2004 of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, European Union (EU)

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Year of Version 2004 Dates Entry into force: April 30, 2004 Adopted: March 31, 2004 Type of Text IP-related Laws   Subject Matter Patents (Inventions) Subject Matter (secondary) Other Notes The notification by the European Union to the WTO under Article 63.2 of TRIPS states:
'Directive No. 2004/27/EC amends definitions and scope of Directive 2001/83/EC, as well as containing provisions on Marketing Authorisation Procedures, in order to further harmonize the legislation on medicinal products for human use and achieve the objective of free and safe movement of medicinal products for human use and the elimination of obstacles to trade of such products in the internal market.'


Available Texts Main text(s) Main text(s) French Directive n° 2004/27/CE du Parlement européen et du Conseil du 31 mars 2004 modifiant la directive n° 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain PDF HTML English Directive No. 2004/27/EC of the European Parliament and of the Council of 31 March 2004 of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use PDF HTML Spanish Directiva N° 2004/27/CE del Parlamento Europeo y del Consejo de 31 de marzo de 2004, que modifica la Directiva N° 2001/83/CE por la que se establece un Código Comunitario sobre Medicamentos de Uso Humano PDF HTML
Related Legislation Amends (1 text(s)) Amends (1 text(s))
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (EU173)
Is implemented by (6 text(s)) Is implemented by (6 text(s))
Patents Act (1967:837) (as amended up to Order (2023:216)) (SE235)
Act No. 378/2007 Coll. of 6 December 2007 on Pharmaceuticals and on Amendments to Some Related Acts (the Act on Pharmaceuticals) (as amended up to Act No. 262/2019 Coll.) (CZ114)
Trademarks Act (2010:1877) (as amended up to Act (2020:545))  (SE221)
The Consolidate Patents Act (Consolidate Act No. 90 of January 29, 2019) (DK212)
Medical Products Act (HR096)
Federal Law on Amendments to the Law on Patents 1970 and the Law on Utility Models (BGBl. I No. 130/2005) (AT153)

WTO Document Reference
IP/N/1/EU/1
IP/N/1/EU/U/1
IP/N/1/EU/17
IP/N/1/EU/U/4

WIPO Lex No. EU175