Dolj Public Health Directorate*
Available procedures
Establishment of a 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.
*Establishing a drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of chief drugstore-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Drug 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 situations where there are changes in the conditions that formed 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.
*Modification of initial authorization conditions - ANY CHANGE 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 formed the basis for issuing the operating license - any other modification made to the space of the pharmaceutical unit, except for 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 modification.
*Resumption of activity during the suspension period of the operating permit 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 registration of the mention of resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity takes place at a different address of the headquarters/working point than the initial one. The documents are sent 60 working days before the expiration of the legal suspension period.
*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 required documentation. The applicant will submit on the platform the documents provided in Ord MS 444/2019 - the transmission of the documents to the DSP, the preparation by the local DSP of the verification report and the conformity or non-conformity decision, and the submission on the platform.
*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. It is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is provided.
*Pharmacy/drugstore authorization - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure addresses pharmaceutical units in situations where the registration of the statement attesting authorization for sale and release through the information society of medicines issued without prescription/specific drugstore products 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 DSP.
