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Request for scheduling the inspection for the authorization / recertification of good distribution practice for wholesale of medicinal products for human use*
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Procedure
Online
Companii
National
Details
The purpose of this procedure is to request the scheduling of the inspection for authorization/recertification of good distribution 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 completions.
The request for scheduling the inspection is drafted according to the model provided in Annex no. 1 to the Order of the Minister of Health no. 131/2016 and is uploaded to the PCUe platform.
The application form for the Authorization for the wholesale distribution of medicinal products for human use is drafted according to the model provided in Annex no. 2 to the Order of the Minister of Health no. 131/2016 and is sent, together with the administrative and technical documents provided 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, at 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 inspection for the authorization / recertification of wholesale units distributing medicinal products for human use*
Descarcă
The template is downloaded, filled out, signed, stamped, scanned, and then uploaded to the platform.*
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
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 failing to resolve a request within the legal period, 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:
Links
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Assistance and problem-solving services
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Last updated:
02 August 2022
Publicat de către:
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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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