EMA has updated its advice about parallel distribution, adding a new query to its frequently asked question document and updating its responses to several existing inquiries.
The new question asks about the requirements for dormant notices. In its response, EMA explains that a product should be updated to the “dormant” status if it has not been distributed in parallel for the last 12 months. There is no fee for changing the status. Distributors do not need to submit annual updates when a product is dormant. An application and annual update must be filed to reintroduce a product.
“The product can then be distributed in parallel once again, from the day of status update in IRIS, provided that the Agency has been made aware of the changes which have occurred since the product was dormant through the annual update procedure,” EMA said.
EMA also updated its response to three questions about the procedures of parallel distribution, where to find the latest published marketing authorizations and what is an annual update.
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