Direct communication to healthcare professionals (DHPC)*
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Companii
National
Cross-border
The purpose of this procedure is to transmit a Direct Communication to healthcare professionals by a marketing authorization holder for the concerned medicine(s), either at the request of ANMDMR or another competent authority from the EU or the European Medicines Agency, or at the initiative of the marketing authorization holder. Before distributing the Communication to healthcare professionals, the marketing authorization holder requests ANMDMR's approval regarding the content of the DCHP and the communication plan.
*Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
Title
Payment method
Value
Currency
Any person who considers themselves harmed in a right of theirs or in a legitimate interest, by ANMDMR through an administrative act or by the failure to resolve a request within the legal term, may address the competent administrative litigation court under the conditions established by the Administrative Litigation Law no. 554/2004.
*Competent entities
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