The Vrancea Public Health Directorate*
Available procedures
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a drugstore—chief unit—chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified at the same time.
*Establishment of distinct spaces within the closed-circuit pharmacy structure 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 than that of the hospital (UF-DSP)*
The procedure is addressed to pharmaceutical units that wish to set up 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 sanitary unit; it is mandatory to submit the operating authorization of the sanitary unit accompanied by the annex in which the pharmacy is specified.
*Pharmacy/drugstore authorization - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where the registration of the mention attesting the authorization for sale and dispensing through the information society of medicines granted without a medical prescription/specific products for drugstores is requested.
*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 DSP.
Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure addresses 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 required documentation. The applicant shall upload on the platform the documents stipulated in Ord MS 444/2019 - sending 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 on the platform.
*Modification of initial authorization conditions - MOVE OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in the event of changes in the conditions that formed the basis for the issuance of the operating license - relocation of headquarters/work point. Changes must be notified to the Ministry of Health - Directorate of Medicine and Medical Devices Policy within 5 working days from the date of the change.
*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.
*Change of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
The procedure addresses pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - any other change 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 of Medicine Policy and Medical Devices within 5 working days from the date of the change.
*Resumption of activity during the suspension period of the operating license or upon expiration of the period - WITH CHANGE OF THE ADDRESS OF THE HEADQUARTERS/WORK LOCATION (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the resumption of activity is requested during the suspension period or upon its expiration. The activity is resumed at a different address of the headquarters/work point than the initial one. The documents are sent 60 working days before the expiration of the legal suspension period.
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