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Medicament Biologics e Biosimilar: Descontinuidades no System de Farmacovigilncia em Portugal Maria the Conceit Constantino PORTELA1, Carlos SINOGAS2,3, Fernando Albuquerque de ALMEIDA4, Ricardo BAPTISTALEITE1,5,

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What is medicamentos biológicos e biossimilares?

Medicamentos biológicos e biossimilares are biologic drugs and biosimilars, which are drugs that are similar to already approved biologic drugs.

Who is required to file medicamentos biológicos e biossimilares?

Manufacturers, importers, and distributors of biologic drugs and biosimilars are required to file medicamentos biológicos e biossimilares.

How to fill out medicamentos biológicos e biossimilares?

Medicamentos biológicos e biossimilares can be filled out using the specific forms provided by the regulatory authorities, with all necessary information about the drug.

What is the purpose of medicamentos biológicos e biossimilares?

The purpose of medicamentos biológicos e biossimilares is to ensure the safety, efficacy, and quality of biologic drugs and biosimilars in the market.

What information must be reported on medicamentos biológicos e biossimilares?

Information such as manufacturing process, composition, stability data, and clinical studies must be reported on medicamentos biológicos e biossimilares.

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