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  3. Establishment of distinct spaces within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or distinct spaces for outpatient dispensing within the PNS, located at the same address or at a different address from that of the hospital (DSP-MS)*

Establishment of distinct spaces within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or distinct spaces for outpatient dispensing within the PNS, located at the same address or at a different address from that of the hospital (DSP-MS)*

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Procedure
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Companii
National

The procedure is addressed to County Public Health Directorates, and respectively the municipality of Bucharest for the establishment of distinct spaces within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or distinct spaces for outpatient dispensing within the NHP, located at the same address or at a different address from that of the hospital - submission of documents to the Ministry of Health - Directorate for Medicines Policy and Medical Devices. The resolution period (3 calendar days) represents the period for transmitting all documents to the Ministry of Health

IMPORTANT!!! Uploaded documents must mandatorily be named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, sector 1), MARIAFARM_BV.pdf

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă

-
Compliance decision for the space designated as a pharmaceutical unit*
Descarcă
Scanned document
The document will be uploaded with the extended electronic signature of DSP*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Inspection report*
Descarcă
Scanned document
The document will be uploaded with the DSP's extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Request type*
Descarcă
Formular tipizat
According to model no. 3 from the Norms approved by OMS no. 444/2019 - The document will be uploaded with the extended electronic signature of the applicant for the issuance of the Authorization/Annex to the Authorization*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă

-
None
Fees

Title

Payment method

Value

Currency

None
Deadlines
Resolution time:
30
Calendar days
Case filling duration:
5
Calendar days
Notification deadline:
1
Calendar days
Appeal routes
In the event of a dispute between the beneficiary and the competent authority, the provisions of common law shall apply.

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
10 March 2025
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.
Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
*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.
Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
Intr. Cristian Popisteanu, nr. 1-3, Sector 1, RO
Telefon: 0213072500
Fax:
Email: relatii.publice@ms.ro
https://www.ms.ro
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Compartimentul Autorizare și Monitorizare Unități Farmaceutice
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