Single digital gateway for public services
Notification of intra-community deliveries of medicinal products for human use included in the Treatment Protocol for SARS-Cov-2 virus infection, as well as medicinal products with a high risk of discontinuation intended for chronic pathologies in the context of the pandemic*
favorite_border
Add favorite
Procedure
Online
Companii
National
The purpose of this procedure is the notification of ANMDMR regarding the performance of an intra-community delivery outside the Romanian territory under certain conditions, according to the provisions of the Order of the Minister of Health no. 672/2020.
The ultimate purpose of the procedure is to ensure the observance of the public service obligation, namely the obligation to provide adequate and continuous stocks of medicines, through temporary restrictive measures concerning their distribution outside the Romanian territory, justified by the protection of public health and proportional to the objectives of this protection.
The notification is prepared in accordance with the Annex to the Order of the Minister of Health no. 269/2017, for each medicinal product, with the information from the Nomenclature of Human Medicines https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: commercial name of the medicine, INN, pharmaceutical form, concentration, pack size, CIM code, ATC code, MAH name) and is sent, together with the centralizing table regarding the notified medicines, prepared in .xls format, via the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to the ANMDMR, the rejection decision in case it considers the decision is unfounded, presenting the necessary arguments in this respect. The contestation is sent on the PCUe platform.
*The ultimate purpose of the procedure is to ensure the observance of the public service obligation, namely the obligation to provide adequate and continuous stocks of medicines, through temporary restrictive measures concerning their distribution outside the Romanian territory, justified by the protection of public health and proportional to the objectives of this protection.
The notification is prepared in accordance with the Annex to the Order of the Minister of Health no. 269/2017, for each medicinal product, with the information from the Nomenclature of Human Medicines https://www.anm.ro/medicamente-de-uz-uman/nomenclatorul-medicamentelor-de-uz-uman (regarding: commercial name of the medicine, INN, pharmaceutical form, concentration, pack size, CIM code, ATC code, MAH name) and is sent, together with the centralizing table regarding the notified medicines, prepared in .xls format, via the PCUe platform.
The economic operator may contest, within a maximum of 2 (two) working days, to the ANMDMR, the rejection decision in case it considers the decision is unfounded, presenting the necessary arguments in this respect. The contestation is sent on the PCUe platform.
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
The centralizer of notified 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
Notification of intra-community delivery with human use medicines (for each medicine)*
Descarcă
Formular tipizat
The template is downloaded, filled out, 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 prepared as an informational document, it is signed, stamped, scanned, and then uploaded to the platform.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Contestation of rejection decision*
Descarcă
Scanned document
It is drawn up as an informational 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 medicines at high risk of discontinuity on the national market*
Appeal routes
Any person who considers themselves harmed in a right or 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 case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
*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.
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
Table of contents
Competent entities
Serviciul Registratură și Arhivă
Direcția Generală Inspecție Farmaceutică
Share your opinion
Provide your opinion about the content of this page. You can leave acomment about what we can improve. You will not receive a response toyour comment. Use the contact form to clarify any questions regardingthe information and services available on this portal.
Did you find what you were looking for?
Help us improve