Hello all,
My company is preparing to file a CP (Centralized Procedure) or DCP (decentralized) application to market a product in Europe. We have co-developed this new product with another company that belongs to the same company group as us.
According to the relevant EU Directive (
http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap1_2013-06_en.pdf) on p 14, "Applicants and marketing authorisation holders belonging to the same company
group or that are controlled by the same physical or legal entity are to be
considered as one entity."
Does this mean that both my company and our family company will each have a marketing authorization for one product (after a marketing authorization is granted for this product) since we are considered as one entity? or should I interpret this differently?
Please share your thoughts or experience. Any input will be highly appreciated.
Thank you in advance for your help.
Sincerely,
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Dahuin Lee
Seoul
Korea, Republic of
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