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La AEMPS aplica el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios (Real Decreto Legislativo 1/2015, que sustituyó a la Ley 29/2006) y el Real Decreto 1015/2009 sobre disponibilidad de medicamentos en situaciones especiales, integrados en el marco europeo de la Agencia Europea de Medicamentos (EMA)
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