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MATERIAL SAFETY DATA SHEET According to article 31 and Annex II of the EU REACH RegulationGRAFEN PROFESSIONAL SANITARY SILICONERevision: 12.07.2013 Update date: 29.12.2017 Version 3.0-Page 1 of 8SECTION

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Step 1: Collect all relevant safety data information

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Step 2: Use the appropriate safety data sheet (SDS) format

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Step 3: Fill out the necessary fields with accurate information

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Step 4: Ensure all hazard warnings and precautionary measures are clearly stated

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Step 5: Review and verify the completed safety data information

Who needs information on safety data?

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What is information on safety data?

Information on safety data refers to data that pertains to the safety and efficacy of products, particularly in the pharmaceutical and medical device sectors. It includes findings from clinical trials, post-market surveillance, and adverse event reporting.

Who is required to file information on safety data?

Manufacturers, researchers, and organizations involved in the development and marketing of pharmaceutical products and medical devices are required to file information on safety data.

How to fill out information on safety data?

To fill out information on safety data, the filer must collect all relevant safety information, document any adverse events, and complete the specific forms or templates required by regulatory agencies, ensuring that all data is accurate and comprehensive.

What is the purpose of information on safety data?

The purpose of information on safety data is to ensure public safety by monitoring the effects of products on health, facilitating regulatory oversight, and enabling informed decisions regarding the use and approval of products.

What information must be reported on information on safety data?

Information that must be reported includes adverse events, product defects, safety alerts, and data from clinical trials related to a product's safety profile.

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