The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs are regulated under the deliberate release framework- part B of Directive 2001/18. The applications to seek authorization under the clinical trials framework and under the GMO framework are not linked (i.e. the applicant can decide the timing of the submission of the GMO application).

Additional information can be found at:
- https://sede.mapama.gob.es/portal/site/se/ficha-procedimiento?procedure_id=413&procedure_ suborg_responsable=79&by=theme
- Ministry of Health and Social Policy
- Ministry of the Environment and Rural and Marine Affairs

Application forms to seek authorisation for the GMO aspects
Application forms can be found at:
https://www.mapama.gob.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/organismos-modificados-geneticamente-omg-/notificaciones-y-autorizaciones/proc_autorizacion.aspx

Public consultation
Information about public consultation on GMO aspects can be found at:
https://www.mapama.gob.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/organismos-modificados-geneticamente-omg-/participacion-publica/liberacion-voluntaria/default.aspx

National authorities involved

Authorization of clinical trials:
Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency of Medicines and Medical Devices)
alle Campezo 1, Edificio 8, E-28022 Madrid
e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it..

Authorisation of GMO aspects:
Consejo Interministerial de OMG (CIOMG)
Comisión Nacional de Bioseguridad (CNB)
Paseo Infanta Isabel, 1, 28014. Madrid.
CIOMG: This email address is being protected from spambots. You need JavaScript enabled to view it.
CNB: This email address is being protected from spambots. You need JavaScript enabled to view it.

(Last reviewed by the Competent Authority: December 2017)