Honduras: ARSA Highlights the Need for Pre-Approval on updates to a Marketing Authorization
Keywords: Regulatory Affairs, Honduras, Medicines, ARSA
Has your company updated the formula of its product or the analytical methodology?
If the answer is yes: Have you already requested the update of the Marketing Authorization from the Health Agency?
Summary
The Health Regulation Agency (ARSA) of Honduras published notice No. A-ARSA-027-V1 on June 10 of the current year. The notice highlights the following:
- The responsibility to keep product dossiers up to date.
- Any changes related to analytical methodologies, finished product specifications, or the qualitative-quantitative formula require prior approval from ARSA.
Who must take action?
Legal representatives, qualified professionals, marketing authorization holders, distributors, representatives, and manufacturers of pharmaceutical products registered in Honduras.
Legal Basis (English Translation):
Central American Technical Regulation, RTCA.
What action should I take as a Marketing Authorization Holder?
If your company holds Marketing Authorizations in Honduras, it is important to periodically review and ensure that they are up to date.
For more information, contact us at: info@scheelconsulting.com
Source: www.arsa.gob.hn
