Venezuela requiring submission of GMP certificate(s) of Drug Substances for sanitary registrations

As of July 1, 2023, it will be mandatory, for applications for Sanitary Registration and post-registration changes that require it, to submit at the time of application to the National Institute of Hygiene "Rafael Rangel" a copy of the certificates of good manufacturing practices of the manufacturer(s) of the active ingredient(s), issued by the corresponding health authority, signed, sealed and legalized (apostilled).

You can find the press release issued by the regulatory authority here (in Spanish):

• CIRCULAR (from 28-mar-23) Certification of good manufacturer of active ingredients is now mandatory for sanitary registrations in Venezuela.