Spanish Legislation

  • Legislation

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  • European Directives

DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31st March 2004 on ‘Setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells’.

COMMISSION DIRECTIVE 2006/17/EC of 8th February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.

COMMISSION DIRECTIVE 2006/86/EC of 24th October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.

 

  • Laws

LAW 41/2002 of 14th November, regulatory plan regarding patient autonomy and rights and obligations regarding information and clinical documentation.

LAW 44/2003 of 21st November, regulation of health professions.

LAW 14/2006 of 26th May, regarding human assisted reproduction techniques.

LAW 29/2006 of 26th July, regarding guarantees and rational use of medicines and healthcare products.

LAW 14/2007 of 3rd July, regarding biomedical research.

 

  • Royal Decrees

ROYAL DECREE 412/1996 of 1st March, establishing ‘Protocols for the Study of Donors of Gametes and Users of Assisted Reproduction Techniques’.

ROYAL DECREE 413/1996 of 1st March, establishing ‘Requirements for the approval of centres and services related to assisted reproduction techniques’.

ROYAL DECREE 415/1997 of 21st March, establishing the National Commission of Human Assisted Reproduction (Official State Bulletin No. 70 of 22nd March 1997).

ROYAL DECREE 120/2003 of 31st January, regulating ‘Requirements of controlled experiments, with reproductive purposes of fertilization with previously frozen oocytes or ovarian tissue, related to the assisted human reproduction techniques’. 

ROYAL DECREE 1277/2003 of 10th October, establishing ‘The general bases for authorization of health centres, services and establishments’.

ROYAL DECREE 223/2004 of 6th February, regulating ‘Clinical trials with medicinal products’.

ROYAL DECREE 2132/2004 of October 29th, establishing ‘Requirements and procedures for the development of research projects with stem cells taken from surplus pre-embryos’.

ROYAL DECREE 1301/2006 of 10th November, establishing ‘Standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells’ and approving ‘Standards for coordination and human use’.

ROYAL DECREE 906/2007 of 6th July, modifying Royal Decree 15/1997 of 21st March, establishing the National Commission of Human Assisted Reproduction.

 

  • Ministerial Orders

MINISTERIAL ORDER of 25th March 1996, establishing the ‘Operating Rules of the National Register of Donors of Gametes and Pre-embryos’.

 

  • Regional Legislation

DECREE 176/2004 of 24th September of the Council of the Generalitat Valenciana, regarding ‘Regional healthcare authorization and registration of health centres, services and establishments’ (DOGV No. 4854 of 01/10/2004).

ORDER of 18th April 2005 of the Regional Health Ministry, regulating ‘Healthcare authorization procedures for health centres and services in the regional area of ​​the Valencian Community (GOGV No. 5038 of 29/06/2005).

 

  • Other relevant legislation

ORGANIC LAW 1/2002 of 22nd March, regulating the ‘Right of Association’.

LAW 3/2007 of 15th March, regulating ‘Registration rectification regarding gender’. 

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