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Galati Public Health Directorate*

Available procedures

PROCEDURA
Companii
National

Establishment of community pharmacy (UF-DSP)*

The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - submission of documents to the Public Health Directorate.

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PROCEDURA
Companii
National

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 (UF-DSP)*

The procedure is addressed to pharmaceutical units that wish to establish closed-circuit pharmacies at an address other than that of the hospital or at the hospital's address being coordinated by the pharmacy within the healthcare unit. The operating authorization of the healthcare unit must be submitted, accompanied by the annex in which the pharmacy is specified.

*
PROCEDURA
Companii
National

Change of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of the headquarters/branch (UF-DSP)*

The procedure addresses pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for the relocation of the headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicinal Policy and Medical Devices within 5 working days from the date of the change.

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PROCEDURA
Companii
National

Establishment of a closed-circuit pharmacy (UF-DSP)*

The procedure is addressed to the establishment of closed-circuit pharmacies that serve healthcare units and/or outpatient clinics; the manager of the healthcare unit submits the application accompanied by the requested documentation. The applicant will submit on the platform the documents stipulated in Order MS 444/2019 - transmission of the documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and uploading them onto the platform.

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PROCEDURA
Companii
National

Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*

The procedure is addressed to drugstores for the establishment of chief unit drugstore-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Department of Medicine Policy and Medical Devices, is also notified simultaneously.

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PROCEDURA
Companii
National

Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*

The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating license - relocation of headquarters/work location. The changes must be notified to the Ministry of Health - Directorate of Medicinal Policy and Medical Devices within 5 working days from the date of the change.

*
PROCEDURA
Companii
National

Authorization of pharmacies/drugstores - ONLINE SALE (Electronic Commerce) (UF-DSP)*

The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying the authorization for sale and release through the information society of medicines granted without a medical prescription/specific drugstore products is requested.

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PROCEDURA
Companii
National

Resumption of activity during the suspension period of the operating license or upon expiration of the period - WITH CHANGE OF THE HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*

The procedure addresses pharmaceutical units in situations where registration of the resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity is carried out at a different address of the headquarters/work point than the initial one. Documents are sent 60 working days before the expiration of the legal suspension period.

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PROCEDURA
Companii
National

Establishment of local distribution office (UF-DSP)*

The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - submission of documents to the Public Health Directorate (DSP).

*
Galati Public Health Directorate*
Str. ROSIORI, nr. 12B
Telefon: 0236 463704
Fax: 0236 464060
Email: dspgl@dsp-galati.ro

Assistance services

There are no Assistance services registered by this institution

Institutional structure

BIROU AVIZE AUTORIZARI
Compartiment Evaluarea Factorilor de Risc din Mediul de Viata si de Munca

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