Olt 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.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where there are changes in the conditions that formed the basis for issuing the operating license - relocation of headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for 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 at the expiration of the interval - WITH THE CHANGE OF THE ADDRESS OF THE HEADQUARTERS/WORK POINT (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 must be submitted 60 working days before the expiration of the legal suspension period.
*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 medical assistant. The Ministry of Health, the Directorate for Drug Policy and Medical Devices, is also notified simultaneously.
*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 for sale and release through the information society of medicines granted without medical prescription/specific drugstore products is requested.
*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 requested documentation. The applicant shall upload on the platform the documents required by Ord MS 444/2019 - submission of documents to the DSP, preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and submission on the platform.
*Establishment of separate areas within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or separate areas 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 while 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 which provides for the pharmacy.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of the 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 for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for relocating the headquarters/secondary location. The changes must be notified to the Ministry of Health - Directorate for Medicine Policy and Medical Devices within 5 working days from the date of the change.
*Establishment of a 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).