Medicines: New Rules for Health Records

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

Wednesday, May 22, 2019

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.

You may be interested in "Pharmaceuticals: Imports up to September 2018" 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.

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More on this topic

Medicines: Changes Approved in Panamanian Market

October 2019

In the third debate, the Assembly approved a bill establishing that the government may make exceptions to the sanitary registration of pharmaceutical products in situations of critical shortage.

At the same time, it empowers the Ministry of Health to purchase medicines under the criteria established by the World Health Organization (WHO), which will allow that when local agents do not participate in the sale, it will be possible to go through international agents, informed the National Assembly on October 3.

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The most important change proposed by the authorities is to make exceptions to the health registration of pharmaceutical products in situations of critical shortage.

After receiving the approval from the Cabinet Council, it is expected that next week, the Minister of Health, Rosario Turner Montenegro, will present before the National Assembly the Draft Law, which seeks to amend Law 1 on Medicines.

Panama: Extension of Registrations for Medicines

August 2016

In order to solve the problem of shortages, health registrations will be automatically extended for pharmaceuticals expiring this month.

The president of the Chamber of Commerce, Industries and Agriculture in Panama said that "... '[Ministers] told us they welcomed the proposal by the Chamber of Commerce to extend the health records of drugs that are expiring between August 14 2016 and August 15 2017.

Pharmaceutical Labeling

August 2015

Panama has adopted the Central American technical regulations on minimum conditions and labeling of pharmaceuticals for human use.

From the Resolution by the Ministry of Health published in La Gaceta:

The purpose of this technical regulation is to establish minimum requirements that must be met in the labeling of pharmaceutical products for human use, both products in the territory of the countries of the Central American region, and foreign ones.

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