The new regulation, which entered into force on May 17, updates the terms and policies on health records of medicines in Panama.

The Regulation containing 611 articles was published in Gaceta Oficial No. 28776-B, and establishes two procedures for granting sanitary registrations, one regular and the other abbreviated, which applies to medicines coming from countries with high standards or strict authorities accredited by international organizations.

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Panamaamerica.com.pa reviews that “… The regulation specifies that the Directorate of Pharmacy and Drugs is the entity that has competence for the issuance, renewal and cancellation of health registration, as well as conducting the work of pharmacovigilance.

Regarding the established norms, the article adds that “… Unjustified breach of contract, delivery of something other than that established in the contract and failure to honor the product warranty are grounds for suspension of accreditation of the provider company for three months if it is for the first time. If it relapses, the suspension is raised to six months and if it fails again for the third time, the accreditation will be definitively cancelled.”

See full regulations.