EU legislation
European Union legislation applicable to the marketing of medicines in Hungary
Source: eur-lex.europa.eu
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017
on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015
supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0161
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
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0083
Guidelines of 19 March 2015
on principles of Good Distribution Practice of active substances for medicinal products for human use
(Text with EEA relevance) (2015/C 95/01)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015XC0321(01)
Guidelines of 5 November 2013
on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) (2013/C 343/01)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013XC1123(01)
COMMISSION IMPLEMENTING REGULATION (EU) No 699/2014 of 24 June 2014
on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0699
REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014
on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536
COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 of 19 June 2012
on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32012R0520
DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011
amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011L0062
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009
on cosmetic products (recast) (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223
REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007
on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32007R1394
REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006
on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006R1901
REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004
laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0726
DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001
on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0020
REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 1999
on orphan medicinal products
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32000R0141
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998
on in vitro diagnostic medical devices
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https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079