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Notification of intra-community deliveries of human medicinal products included in the Treatment Protocol for SARS-CoV-2 virus infection, as well as of high-risk medicines for discontinuity intended for chronic diseases in the context of the pandemic*
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Procedure
Online
Companii
National
The purpose of this procedure is to notify ANMDMR regarding the execution of an intra-community delivery outside the territory of Romania under certain conditions, according to the provisions of the Order of the Minister of Health no. 672/2020.
The final purpose of the procedure is to ensure the observance of the public service obligation, namely the obligation to ensure adequate and continuous stocks of medicines, through temporary restrictive measures regarding their distribution outside the territory of Romania, justified by public health protection and proportional to the objectives of this protection.
The notification is completed according to the Annex to the Order of the Minister of Health no. 269/2017, for each medicine, with information from the Nomenclature of human use medicines https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (referring to: medicinal product trade name, INN, pharmaceutical form, strength, pack size, CIM Code, ATC Code, MAH name) and is submitted, together with the centralizing table regarding the notified medicines, completed in .xls format, in the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to ANMDMR, the rejection decision if they consider the decision to be unfounded, presenting the necessary arguments in this regard. The contestation is submitted in the PCUe platform.
*The final purpose of the procedure is to ensure the observance of the public service obligation, namely the obligation to ensure adequate and continuous stocks of medicines, through temporary restrictive measures regarding their distribution outside the territory of Romania, justified by public health protection and proportional to the objectives of this protection.
The notification is completed according to the Annex to the Order of the Minister of Health no. 269/2017, for each medicine, with information from the Nomenclature of human use medicines https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (referring to: medicinal product trade name, INN, pharmaceutical form, strength, pack size, CIM Code, ATC Code, MAH name) and is submitted, together with the centralizing table regarding the notified medicines, completed in .xls format, in the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to ANMDMR, the rejection decision if they consider the decision to be unfounded, presenting the necessary arguments in this regard. The contestation is submitted in the PCUe platform.
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
The notifier of registered medicines*
Descarcă
Formular tipizat
It is prepared only in .xls format. The template is downloaded, completed, and then uploaded to the platform.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Intra-community delivery notification with human-use medicines (for each medicine)*
Descarcă
Formular tipizat
The template is downloaded, filled in, signed, stamped, scanned, and then uploaded to the platform.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Forwarding address*
Descarcă
Scanned document
It is drawn up as an informational document, signed, stamped, scanned, and then uploaded to the platform*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Appeal against rejection decision*
Descarcă
Scanned document
It is drawn up as an informative document, it is signed, stamped, scanned, and then uploaded to the platform.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
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 the approval of the List comprising 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 certain measures to ensure the supply of medicines with a high risk of discontinuity on the national market*
Appeal routes
Any person who considers themselves harmed in one of their rights 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.
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
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.
National Agency for Medicines and Medical Devices of Romania*
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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