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