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 under the NHP, located at the same address or at a different address from that of 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 the establishment of 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 request accompanied by the required documentation. The applicant will submit on the platform the documents stipulated in Ord MS 444/2019 - transmission of documents to DSP, preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and submission on the platform.
*Resumption of activity during the suspension period of the operating license or upon expiration of the interval - WITH CHANGE OF HEADQUARTERS/WORK POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where 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 the establishment of chief drugstore-unit pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Directorate for Drug Policy and Medical Devices, 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 situations where there are changes to the conditions that were the basis for the issuance of the operating authorization - relocation of headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicinal Product Policy and Medical Devices within 5 working days from the date of the change.
*Modification of initial authorization conditions -ANY MODIFICATION TO THE SPACE - Does not include relocation of headquarters/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - any other change affecting the space of the pharmaceutical unit, except for relocating the headquarters/working point. Changes must be notified to the Ministry of Health - Directorate of Medicines Policy and Medical Devices within 5 working days from the date of the change.
*Pharmacy/drugstore authorization – ONLINE SALE (Electronic Commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying the authorization to sell and release, through the information society, medicines that are provided without a medical prescription/specific drugstore products is requested.
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