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Notification of intra-community deliveries of human-use medicines by authorized wholesale distributors*
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Procedure
Online
Companii
National
Details
The purpose of this procedure is to notify ANMDMR regarding the carrying out of an intra-community delivery, including transactions between two or more representatives of the same company located in different countries, in accordance with the provisions of the Order of the Minister of Health no. 269/2017.
The final purpose of the notification is to ensure compliance with the public service obligation, namely the obligation to maintain adequate and continuous stocks of medicines.
The notification is prepared according to the Annex of the Order of the Minister of Health no. 269/2017, for each medicine, with information from the Nomenclature of human use medicineshttps://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: commercial name of the medicine, INN, pharmaceutical form, concentration, packaging size, CIM code, ATC code, MAH name) and is submitted, together with the centralized table regarding the notified medicines, prepared in .xls format, in the PCUe platform.
*The final purpose of the notification is to ensure compliance with the public service obligation, namely the obligation to maintain adequate and continuous stocks of medicines.
The notification is prepared according to the Annex of the Order of the Minister of Health no. 269/2017, for each medicine, with information from the Nomenclature of human use medicineshttps://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: commercial name of the medicine, INN, pharmaceutical form, concentration, packaging size, CIM code, ATC code, MAH name) and is submitted, together with the centralized table regarding the notified medicines, prepared in .xls format, in the PCUe platform.
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
The register of notified medicines*
Descarcă
It is prepared only in .xls format. The template is downloaded, filled in, and then uploaded to the platform.*
Intra-community delivery notification with human-use medicines (for each medicine)*
Descarcă
The form is downloaded, filled in, signed, stamped, scanned, and then uploaded to the platform.*
Forwarding address*
Descarcă
It is drawn up as an informational document, it is signed, stamped, scanned and then uploaded to the platform.*
Issued documents
Denumire
Tip document
Descarcă
-
None
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
5
Calendar days
Case filling duration:
0
Calendar days
Notification deadline:
1
Calendar days
Legislation
Appeal routes
Any person who considers themselves harmed in a right or a legitimate interest, by ANMDMR through an administrative act or by failing to resolve a request within the legal term, may address the competent administrative court under the conditions established by the Administrative Litigation Law no. 554/2004.
In the case of a dispute between the beneficiary and the competent authority, common law provisions are applicable.
*Additional information
More info:
Links
Assistance and problem-solving services
None
Last updated:
02 August 2022
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.
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.
Str. Aviator Sănătescu 48
Telefon:
+40213171100
Fax:
+40213163497
Email:
secretariat@anm.ro
Table of contents
Competent entities
Serviciul Registratură și Arhivă
Direcția Generală Inspecție Farmaceutică
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