On November 8th, through Executive Decree No. 331, the Ministry of Health modified the procedure to update existing health records. As of the date, the general rule is that all those modifications and notifications (e.g. change of manufacturer, commercial name of the product, administration routes, among others) that are intended to be made to a current Sanitary Registry, will not include direct annotations to the Certificate, but that each change or modification will involve the issuance of a New Certificate of Sanitary Registration.
Also, the National Directorate of Pharmacy and Drugs will admit the use of technology and accept the submission of electronic documents, as long as they comply with the current legislation.
Finally, it regulates the use of inkjet printing for labels, packaging or packaging of pharmaceutical products. Now the manufacturer and/or pharmaceutical establishment will be required to fulfill with particular requirements. For its part, companies that provide this printing service are required to manage an Operation License and a Quality Assurance for storage.