Acuerdo 506-2002 / Resolución 93-2002 (COMIECO-XXIV)

Acuerdo No. 506-2002 of the Ministerio de Economía (Guatemala, 31 de octubre de 2002, signed by Ministra Patricia Ramírez Ceberg), which publishes the COMIECO resolution Resolución No. 93-2002 (COMIECO-XXIV) — the Central American mutual recognition of medicine sanitary registrations, the single format for the Certificado de Producto Farmacéutico, and, in its ANEXO 3, the Reglamento de Buenas Prácticas de Manufactura de la Industria Farmacéutica (243 articles across eleven títulos). Eight annexes in all: the mutual recognition procedure, the certificate format, the GMP reglamento, the list of pharmacopoeias and scientific literature, the alphanumeric coding for sanitary registrations, the sampling requirements, the GMP inspection and self-inspection guide, and the grounds for cancelling a recognised registration. Two things a reader must not miss. First, the resolution's own numeral 3 states that it "no es aplicable ni surte efectos en Costa Rica y Guatemala" — Guatemala publishes the regional instrument without applying it territorially, so this row is evidence of the regional framework and not of a Guatemalan approval route; the operative Guatemalan route is AG 712-99. Second, ANEXO 3 misnumbers its ninth título as "TITULO IV" (TÍTULO IV appears twice and TÍTULO IX never appears), so the block ids follow the título's position while the label keeps the numeral the source prints.

Acuerdo 506-2002 / Resolución 93-2002 (COMIECO-XXIV) is the official identifier MSPAS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.