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 establishing a drugstore - unit chief - chief pharmacist or chief pharmacy technician. The Ministry of Health, the Directorate for Medicine Policy and Medical Devices, is also notified simultaneously.
*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 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 address being coordinated by the pharmacy in the health unit; it is mandatory to submit the operating authorization of the health unit accompanied by the annex in which the pharmacy is specified.
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the registration of the mention certifying the authorization to sell and dispense, through information society means, medicines that are granted without medical prescription/specific products for drugstores is requested.
*Establishment of a 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).
Establishment of a closed circuit pharmacy (UF-DSP)*
The procedure addresses the establishment of closed-circuit pharmacies serving healthcare units and/or outpatient clinics; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant shall submit on the platform the documents provided for in Order MS 444/2019 – sending the documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the conformity or non-conformity decision, and submission on the platform.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure applies to pharmaceutical units in situations where there are changes to the conditions that were the basis for issuing the operating authorization - relocation of headquarters/branch. 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.
*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.
*Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis of the operating authorization - any other changes made to the pharmaceutical unit's space, except for relocating the headquarters/work point. 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 modification.
*Resumption of activity during the suspension period of the operating permit or at the expiration of the period - WITH CHANGE OF ADDRESS OF THE HEADQUARTERS/WORKING POINT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where entering the mention of resumption of activity is requested during the suspension interval or at its expiration. The resumption of activity takes place at a different address of the headquarters/branch than the initial one. The documents are sent 60 working days before the expiration of the legal suspension period of activity.
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