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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS1This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are
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How to fill out black triangle scheme
How to fill out black triangle scheme
01
Obtain necessary information about the black triangle scheme and its requirements.
02
Identify the specific product or medical device that falls under the black triangle scheme.
03
Fill out the required documentation accurately and completely, providing all necessary details and information.
04
Submit the filled out documentation to the appropriate regulatory authority or agency responsible for monitoring the black triangle scheme.
05
Await approval or feedback from the regulatory authority regarding the product's inclusion in the black triangle scheme.
Who needs black triangle scheme?
01
Manufacturers of new drugs or medical devices that are authorized for marketing but are subject to additional monitoring and surveillance.
02
Healthcare professionals who want to stay informed about newly approved products with limited data on safety and efficacy.
03
Patients who want to be aware of new medications or medical devices that may have safety concerns or unknown side effects.
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What is black triangle scheme?
The black triangle scheme is a reporting system used to monitor the safety of medicines that have been newly approved.
Who is required to file black triangle scheme?
Marketing authorization holders are required to file the black triangle scheme.
How to fill out black triangle scheme?
The black triangle scheme can be filled out online through the regulatory authority's designated portal.
What is the purpose of black triangle scheme?
The purpose of the black triangle scheme is to closely monitor the safety and effectiveness of newly approved medicines.
What information must be reported on black triangle scheme?
Information such as adverse events, side effects, and any relevant safety data must be reported on the black triangle scheme.
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