May 2022 - Dc Blue

Actualización del listado de productos referentes para demostración de biosimilaridad

Update of the list of reference products for demonstration of biosimilarity

Leave a Comment / Biotechnological / By CleverDigital

On November 16, 2021, the Ministry of Health has issued the Exempt Decree No. 62 that modifies the exempt decree No. 945 that approves the technical guideline No. 170 on health registration of biotechnological products derived from recombinant DNA techniques. The most relevant changes included in Decree No. 62 are the following: Update of the …

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Alignment in relation to the condition of sale and graphic labeling of medicines

Leave a Comment / Pharmaceutical / By CleverDigital

Exempt Resolution N°395 On March 8, 2022, the Institute of Public Health has issued exempt resolution No. 395, instructing the Department of the National Medicines Agency, ANAMED, to consider rules regarding the graphic labeling of medicines. Avoid legends related to the type of establishment that can market the product. The approved sales conditions must be …

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Nuevo Formulario de notificación de eventos supuestamente atribuibles a la vacunación o inmunización (ESAVI)

New Form for Reporting Events Supposedly Attributable to Vaccination or Immunization (ESAVI)

Leave a Comment / Pharmacovigilance / By dcblue

Exempt Resolution N° 521 On March 18, 2022, the Public Health Institute has issued exempt resolution No. 521, approving the ESAVI notification form based on the need expressed by the Pharmacovigilance subdepartment to create a new version in order to incorporate information necessary to improve the monitoring of cases and the quality of the data …

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