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Notification of intra-community deliveries of human-use medicines included in the treatment protocol for SARS-CoV-2 virus infection, as well as of medicines with a high risk of discontinuity intended for chronic pathologies in the context of the pandemic*
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Procedure
Online
Companii
National
Details
The purpose of this procedure is to notify ANMDMR regarding the performance of an intra-community delivery outside the territory of Romania under certain conditions, according to the provisions of Order of the Minister of Health no. 672/2020.
The final purpose of the procedure is to ensure compliance with the public service obligation, namely the obligation to provide adequate and continuous stocks of medicines, through temporary restrictive measures regarding their distribution outside the territory of Romania, justified by the protection of public health and proportional to the objectives of this protection.
The notification is drawn up according to the Annex to the Order of the Minister of Health no. 269/2017, for each medicine, with the information from the Nomenclature of Medicinal Products for Human Use https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: commercial name of the medicine, INN, pharmaceutical form, concentration, package size, CIM code, ATC code, MAH name) and is sent, together with the centralized table regarding the notified medicines, prepared in .xls format, through the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to ANMDMR, the decision of rejection if it considers the decision to be unfounded, presenting the necessary arguments. The contestation is submitted through the PCUe platform.
*The final purpose of the procedure is to ensure compliance with the public service obligation, namely the obligation to provide adequate and continuous stocks of medicines, through temporary restrictive measures regarding their distribution outside the territory of Romania, justified by the protection of public health and proportional to the objectives of this protection.
The notification is drawn up according to the Annex to the Order of the Minister of Health no. 269/2017, for each medicine, with the information from the Nomenclature of Medicinal Products for Human Use https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: commercial name of the medicine, INN, pharmaceutical form, concentration, package size, CIM code, ATC code, MAH name) and is sent, together with the centralized table regarding the notified medicines, prepared in .xls format, through the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to ANMDMR, the decision of rejection if it considers the decision to be unfounded, presenting the necessary arguments. The contestation is submitted through the PCUe platform.
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Centralizer of notified medicines*
Descarcă
It is prepared only in .xls format. The template is downloaded, completed, and then uploaded to the platform.*
Notice of intra-community delivery with human-use medicines (for each medicine)*
Descarcă
The form is downloaded, completed, signed, stamped, scanned, and then uploaded to the platform.*
Forwarding address*
Descarcă
It is drawn up as an informative document, it is signed, it is stamped, it is scanned and then uploaded to the platform*
Appeal against rejection decision*
Descarcă
It is drawn up as an informative document, it is signed, stamped, scanned, and then uploaded to the platform.*
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
7
Calendar days
Case filling duration:
0
Calendar days
Notification deadline:
1
Calendar days
Legislation
- Law number
672
dated year
2020
ORDER No. 672 of April 23, 2020 for approving the List including the medical devices necessary to ensure the prevention and treatment of conditions associated with SARS-CoV-2 infection, whose distribution is temporarily suspended, as well as measures to ensure the supply of medicines with a high risk of discontinuity on the national market*
Appeal routes
Any person who considers themselves injured in a right or a legitimate interest, by ANMDMR through an administrative act or through 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.
In the case of a dispute between the beneficiary and the competent authority, the provisions of common law apply.
*Additional information
More info:
Links
Assistance and problem-solving services
None
Last updated:
12 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
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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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