Dolj Public Health Directorate*
Available procedures
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.
*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 – head of unit – chief pharmacist or chief pharmacy assistant. The Ministry of Health, the Directorate for Medicine Policy and Medical Devices is also notified simultaneously.
*Modification of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where changes occur in the conditions that formed the basis for the issuance of the operating authorization - relocation of headquarters/point of work. The changes must be notified to the Ministry of Health - Department of Medicine Policy and Medical Devices within 5 working days from the date of the change.
*Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include the relocation of the headquarters/branch (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions underlying the issuance of the operating authorization - any other modification affecting the premises of the pharmaceutical unit, except for the relocation of the 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.
*Resumption of activity during the suspension period of the operating authorization or upon expiration of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the mention of resuming activity is requested during the suspension period or at its expiration. The resumption of activity takes place at a different address of the headquarters/working point than the initial one. Documents must be submitted 60 working days before the expiration of the legal suspension period.
*Setting up a closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed circuit pharmacies that serve healthcare units and/or outpatient care; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will upload to the platform the documents provided for in Order MS 444/2019 - submission of documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the compliance or non-compliance decision, and uploading them to the platform.
*Establishment of distinct spaces within the structure of the closed-circuit pharmacy at a different address than 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 of the healthcare unit; it is mandatory to submit the operating authorization of the healthcare 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 situations where the registration of the statement certifying the authorization for sale and dispensing via the information society of medicines granted without a 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 - sending documents to the Public Health Directorate (DSP).
