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  3. Direct communication to healthcare professionals (DHCP)*

Direct communication to healthcare professionals (DHCP)*

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Procedure
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Companii
National
Cross-border

The purpose of this procedure is to transmit a Direct Healthcare Professional Communication by a marketing authorization holder for the concerned medicinal product(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 the approval of ANMDMR regarding the content of the DHPC and the communication plan.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Direct communication to healthcare professionals (DCHP) - English*
Descarcă
Formular tipizat
- the document is downloaded, filled out, and then uploaded to the platform*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Communication plan of CDPDS - English*
Descarcă
Formular tipizat
- the document is downloaded, completed, and then uploaded to the platform*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Request address for CDPDS approval*
Descarcă
Formular tipizat
- the document is downloaded, completed, and then uploaded to the platform*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Direct Healthcare Professional Communication (DHPC)*
Descarcă
Scanned document
- informational document*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
CDPDS Communication Plan*
Descarcă
Scanned document
- informative document*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
Direct communication to healthcare professionals (DCHCP) approved*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
CDPDS communication plan approved*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Approval/rejection address of CDPDS*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Fees

Title

Payment method

Value

Currency

None
Deadlines
Resolution time:
90
Calendar days
Case filling duration:
15
Calendar days
Notification deadline:
1
Calendar days
Appeal routes

Any person who considers themselves harmed in a right of theirs or in a legitimate interest, by ANMDMR through an administrative act or by failing to resolve a request within the legal timeframe, may address the competent administrative court under the conditions established by Administrative Litigation Law no. 554/2004.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
17 February 2021
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Institution responsible with document: 
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
The National Agency for Medicines and Medical Devices of Romania*
*Content marked with an asterisk (*) has been automatically translated and may not fully reflect the original meaning. For objective interpretation, please consult the Romanian version.
The National Agency for Medicines and Medical Devices of Romania*
Str. Aviator Sănătescu 48
Telefon: +40213171100
Fax: +40213163497
Email: secretariat@anm.ro
www.anm.ro
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Competent entities

Direcţia Farmacovigilenţă şi Managementul Riscului

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