Drug product certificate renewal in Argentina

In Argentina, once granted the registration by ANMAT, product certificates expire in 5 years. The registration renewal procedure is relatively very simple, almost an entirely administrative procedure. The request for renewal has to be submitted within 30 days prior to the certificate expiration date, and should include the following documents:

• Written request
• Sworn statement – marketed/non marketed status
• Evidence of marketing
• Certified copy of original certificate
• Copy of last approved labeling texts

Last update: October 2013