Giurgiu Public Health Directorate*
Available procedures
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 the hospital (UF-DSP)*
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 the DSP.
Establishment of community pharmacy (UF-DSP)*
The procedure is addressed to Pharmaceutical Units for establishing community pharmacies - submission of documents to the Public Health Directorate
*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 will submit on the platform the documents provided in Order MS 444/2019 – the transmission of documents to the Public Health Directorate (DSP), the preparation by the local DSP of the inspection report and the decision of compliance or non-compliance, and their submission on the platform.
*Resumption of activity during the suspension period of the operating authorization or upon expiry of the period - WITH CHANGE OF ADDRESS OF THE HEADQUARTERS/WORKING POINT (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where the request is made to register the mention of resumption of activity during the suspension period or upon its expiration. The resumption of activity is carried out at a different address of the headquarters/work 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 chief - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of the head drugstore - head pharmacist or head pharmacy medical assistant unit. The Ministry of Health, the Directorate of Drug and Medical Devices Policy, is also notified simultaneously.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where changes occur in the conditions that were the basis for issuing the operating authorization - moving 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.
*Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include moving the headquarters/working point (UF-DSP)*
The procedure addresses pharmaceutical units in situations where changes occur to the conditions that formed the basis for issuing the operating authorization - any other modification affecting the pharmaceutical unit's premises, except for relocation of the headquarters/working point. The modifications must be notified to the Ministry of Health - Directorate for Medicine Policy and Medical Devices within 5 working days from the date of modification.
*Authorization of pharmacies/drugstores - ONLINE SALES (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where the registration of the mention attesting to the authorization to sell and dispense through the information society of medicines granted without a medical prescription/specific drugstore products is requested.
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