IMIM - Institut Hospital del Mar d'Investigacions Mèdiques IMIM - Institut Hospital del Mar d'Investigacions Mèdiques

Legal regulations CEIm-PSMAR

  • Law 14/2007 on Biomedical Research.
  • Royal Decree 1716/2011, of 18th November, establishing the basic requirements for the authorisation and operation of biobanks for biomedical research and the treatment of biological samples of human origin, and regulating the operation and organisation of the National Register of Biobanks for Biomedical Research.
  • Law 29/2006, of 26th July, on guarantees and the rational use of medicines and health products.
  • Royal Decree 1090/2015 of 4th December, 2015, establishing the requirements for conducting clinical trials with medicines.
  • Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16th April, 2014, on clinical trials on medicinal products for human use; and which repeals Directive 2001/20.
  • Order SCO/362/2008 of 4th February. Amends Order SCO/256/2007, of 5th February, which establishes the principles and detailed guidelines for good clinical practice and the requirements for authorising the manufacture or import of investigational medicinal products for human use. (Official State Gazette (BOE) 41, 16th February).
  • Royal Decree 577/2013, of 26th July, regulating the pharmacovigilance of medicines for human use.
  • Order SAS/3470/2009 of 16th December, on the guidelines for post-authorisation studies of an observational nature for medicinal products for human use
  • Royal Decree 1591/2009, of 16th October, regulating medical devices (Official State Gazette (BOE) no. 268, 6th November).
  • Royal Decree 1616/2009, of 26th October, regulating active implantable medical devices
  • Circular 7/2004. Clinical research with medical devices.
  • Organic Law 3/2018 of 5th December on the Protection of Personal Data and the Guarantee of Digital Rights
  • Standards of Good Clinical Practice (CPMP/ICH/135/95)
  • Declaration of Helsinki (64th General Assembly, Fortaleza, Brazil, October 2013) Ethical principles for medical research involving human subjects.
  • Law 41/2002, of 14th November, basic regulation of patient autonomy and rights and obligations regarding clinical information and documentation.
  • Oviedo Convention of 4th April, 1997, on human rights and biomedicine, ratified in the Official State Gazette (BOE) of 20th October, 1999.
  • Belmont Report of 18th April, 1979, on ethical principles for the protection of human subjects of research.
  • Nuremberg Code (1947).
  • Contact

    Secretaría técnica:
    Cristina Llop(ELIMINAR)

    Horari: 9 a 14 dll-dv

    Tel:
    93 316 06 79

    Fax:
    93 316 06 36

    1ª planta, espai 163.05 c/Doctor Aiguader, 88 (Edifici PRBB)
    08003 Barcelona

  • Contact

    Secretaria Administrativa:
    Esther Catalan(ELIMINAR)

    Horari: 9 a 14 dll-dv

    Tel:
    93 316 06 77

    Fax:
    93 316 06 36

    1ª planta, espai 163.05 c/Doctor Aiguader, 88 (Edifici PRBB)
    08003 Barcelona

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