Panama- Industry Property and Regulatory Affairs news

Panama- Industry Property and Regulatory Affairs news

1.New Decree that regulates Law No. 1 dated January 10, 2001 that regulates Pharmaceuticals and other health products

On May 18, 2019, Executive Decree No. 95 of May 14, 2019, which regulates Law 1 on Medicines and Other Products for Human Health, became effective. Subrogates Decree 40 of February 13, 2019 due to inconsistencies found.

This Decree is intended to update the requirements and costs for health registration and renewal for pharmaceuticals, cosmetics, disinfectants, personal hygiene products, pesticides were updated.

2. On October 4, 2019, Executive Decree No. 490 of October 4, 2019, Regulating Law 90 of December 26, 2017 on medical devices and related products, began to govern.
In summary the Decree establishes the following:

  1. The National Directorate of Medical Devices is created dedicated exclusively to everything related to medical devices.
  2. The current nomenclature system established by the Pan American Health Organization is adopted.
  3. Risk levels are adopted for the classification of medical devices
  4. Implementation of new Medical Device License to import and distribute locally

3. On June 12, 2019, Resolution No. 550 of May 29, 2019, which regulates the registration of vitamin, dietary and nutritional supplements with therapeutic properties, became effective.
In summary the Decree:

  1. Establishes a procedure for the registration of vitamin, dietary and nutritional supplements with therapeutic properties.
  2. The requirements and costs for registration and renewal are detailed.

4. Since last July 15, 2019, work is being done on a bill to eliminate the Panamanian Food Safety Authority (AUPSA), which is the entity in charge of introducing food for human and animal consumption into the national territory, and in a period of 120 days the authorities must present the bill to the National Assembly and approve the transfer of AUPSA to Ministry of Health and Ministry of Agricultural Development respectively. If this bill is passed, Ministry of Health will then be responsible for the safety of human health foods, export approval and food care laboratories.

5. Resolution 569 of June 10, 2019 published in the Official Gazette on June 20, 2019, whereby the Guide to the Evaluation of Good Practices for Storage, Distribution and Transport of medicines and other products for human health is adopted as support for the performance of audit and self-inspection processes in each commercial establishment that is dedicated to the Storage, Distribution and Transportation of medicines and other products for human health, under the jurisdiction of the National Pharmacy and Drug Directorate.

 6. On September 4, 2019, the Minister of Commerce presented to the National Assembly the Free Trade Agreement signed between Panama and Israel. First FTA that is negotiated with a Middle Eastern country in relation to trade in goods and services. 

7. On August 13, 2019, Bill 11 created by the Ministry of Culture was approved in the Third Debate. This reform brings as a consequence that the Directorates of Copyright, Crafts, Cinematographic, Audiovisual Industry and state radio and Television system will become part of the Ministry of Culture. Currently, the Copyright Department is part of the Ministry of Commerce together with the General Directorate of Industrial Property Law.

 8. On October 3, 2019, Bill 55, which modifies Law 1 on Medicines was approved in the Third Debate, with the purpose of streamlining procedures and expediting the process of purchasing medications, streamlining the process and avoiding shortages. Among other things, it seeks to expedite the processing of health records by automating online processes. To apply, pharmaceuticals must be from High Standard countries.

Yolianna Arosemena Benedetti
CENTRAL LAW
Panama

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