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Request for scheduling the inspection for the authorization / recertification of good wholesale distribution practice of medicinal products for human use*
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Procedure
Online
Companii
National
The purpose of this procedure is to request the scheduling of an inspection for the authorization/recertification of good practice for wholesale distribution of medicinal products for human use, by a wholesale distributor of medicinal products for human use, according to the provisions of the Order of the Minister of Health no. 131/2016, with subsequent amendments and additions.
The request for inspection scheduling is prepared according to the model provided in Annex no. 1 of the Order of the Minister of Health no. 131/2016 and uploaded to the PCUe platform.
The application form for the Wholesale Distribution Authorization for medicinal products for human use is prepared according to the model provided in Annex no. 2 of the Order of the Minister of Health no. 131/2016 and is sent, together with the administrative and technical documents specified in Art. 4 (5) of the Order of the Minister of Health no. 131/2016, directly to ANMDMR, electronically using the ANMDMR upload platform at https://www.anm.ro/upload/ or by email to registratura@anm.ro or in printed format using courier services, to the address Str. Av. Sănătescu no. 48, sector 1, 011478 Bucharest.
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
Request for scheduling the inspection for the authorization / recertification of wholesale distribution units of medicinal products for human use*
Descarcă
Formular tipizat
The form is downloaded, completed, 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:
20
Calendar days
Case filling duration:
0
Calendar days
Notification deadline:
1
Calendar days
Legislation
- Law number
131
dated year
2016
ORDER No. 131 of February 4, 2016 for the approval of the Rules regarding the authorization of wholesale distribution units of medicinal products for human use, good distribution practice certification, and registration of brokers of medicinal products for human use*
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 failure 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, the common law provisions are applicable.
*Additional information
More info:
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Assistance and problem-solving services
None
Last updated:
02 August 2022
Publicat de către:
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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.
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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