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Order no. 1.353 of 30 July 2020 on amendment and supplementation of Order of the Minister of Health no. 861/2014 on approval of criteria and methodology for assessment of health technologies, of documentation

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Gather all necessary information and documentation required for the application process.

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Submit the application form along with any supporting documents to the national agency for medicines.

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Individuals who require access to regulated medicines

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Healthcare professionals prescribing medications

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Pharmaceutical companies seeking approval for new drugs

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What is national agency for medicines?

The national agency for medicines is a government organization responsible for regulating and overseeing the safe and effective use of medicines in a country.

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Pharmaceutical companies, manufacturers, and distributors are typically required to file with the national agency for medicines.

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Filing with the national agency for medicines usually involves submitting detailed information about the medicines being marketed or distributed, including safety and efficacy data.

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The purpose of the national agency for medicines is to ensure that all medicines available to the public are safe, effective, and of high quality.

What information must be reported on national agency for medicines?

Information such as drug approval status, adverse reactions, and post-marketing surveillance data may need to be reported to the national agency for medicines.

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