Conformity assessment of medicaments

Reglamento de control oficial y evaluación de la conformidad de medicamentos (Regulations for the official control and conformity assessment of medicaments); (40 pages, in Spanish)

The notified regulations establish the official control measures, procedures and mechanisms applied by the Ministry of Health, coordinated through the Directorate for the regulation of health-related products and products posing a health risk, to assess the conformity of medicaments and their inputs, prior to and during marketing, based on the approved specifications in the health register or as set out in the official pharmacopoeias.