Single digital gateway for public services
Request for scheduling the inspection for the authorization / recertification of good practice in wholesale distribution of medicines for human use*
favorite_border
Add favorite
Procedure
Online
Companii
National
The purpose of this procedure is to request the inspection scheduling for the authorization / recertification of good wholesale distribution practice of medicines for human use, by a wholesale distributor of medicines 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 scheduling the inspection is prepared according to the model provided in Annex no. 1 to the Order of the Minister of Health no. 131/2016 and uploaded to the PCUe platform.
The application form for the Authorization for wholesale distribution of medicines for human use is prepared according to the model provided in Annex no. 2 to the Order of the Minister of Health no. 131/2016 and 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, in electronic format, 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 human medicines*
Descarcă
Formular tipizat
The model is downloaded, filled in, 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, the certification of good distribution practice, and the registration of brokers of medicinal products for human use*
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 Law on Administrative Litigation no. 554/2004.
In the case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
*Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
02 August 2022
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