The ANSM is making a new section accessible on its website which facilitates the declaration of adverse reactions linked to various health products.
A new section is available on the Medicines Safety Agency website (ANSM). It allows everyone to report side effects suspected of being linked to the use of different health products. Accessible from the home page, this section offers an interface that the ANSM describes as “more readable and more reliable.” “
Report side effects
The new side effect reporting page distinguishes each step. You must first select the health product you want to report (drug, medical device or other), what type of declarant (patient, health professional, industrial). The downloadable form is then displayed. The information for completing and submitting it is available on the same page. “For the collection of adverse effects linked to drugs, filling out the form online takes at most ten minutes,” said the ANSM in a press release.
For drug-related declarations, the online form can be sent by email to the appropriate Regional Pharmacovigilance Center (CRPV), which will forward the information to the ANSM after verification. This form is updated to match the new standards, although it is still possible to use the old ones.
Simplified access to information
The ANSM monitors health products after they have been placed on the market. Its purpose is to enhance patient safety. A vigilance system is in place for eight types of health products: drugs, medical devices, in vitro diagnostic devices, blood products, psychoactive substances, biological products, cosmetics and tattoo products. The Agency collects, records and assesses reports of adverse reactions. If they are confirmed, they are then transmitted to the European pharmacovigilance database.
This database is based on feedback from healthcare professionals and industry, but also from patients and patient associations. In 2012, 38,296 declarations were collected. The ANSM hopes that with this simplified section, the reports will always be more numerous. Online reporting is currently limited to drugs, but it is expected to expand “soon” to medical devices.
This new section also provides information. It is possible to access information on the vigilance system. Health professionals can consult the vigilance bulletin issued by the ANSM.
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