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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 a Black Triangle Scheme form from the appropriate regulatory authority.
02
Fill out the form accurately and completely, providing all required information.
03
Submit the completed form along with any supporting documentation to the regulatory authority.
04
Follow up with the regulatory authority to ensure that the Black Triangle Scheme is properly processed.
Who needs black triangle scheme?
01
Individuals or companies who have developed a new pharmaceutical product and want to request conditional market authorization for it.
02
Individuals or companies who want to monitor and report any adverse reactions or safety issues relating to a pharmaceutical product on the market.
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What is black triangle scheme?
The black triangle scheme is a reporting system that tracks adverse reactions and side effects of new prescription medications.
Who is required to file black triangle scheme?
Pharmaceutical companies or manufacturers are required to file black triangle scheme.
How to fill out black triangle scheme?
The black triangle scheme can be filled out online through the designated regulatory authority's website.
What is the purpose of black triangle scheme?
The purpose of the black triangle scheme is to monitor and evaluate the safety of new medications in the market.
What information must be reported on black triangle scheme?
Information such as adverse reactions, side effects, patient demographics, and medication details must be reported on the black triangle scheme.
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