Bacau Public Health Directorate*
Available procedures
Establishment of a drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a drugstore-chief unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.
*Resumption of activity during the suspension period of the operating license or at the expiration of the period - WITH CHANGE OF THE 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 within 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. Documents must be submitted 60 working days before the expiration of the legal suspension period.
*Establishment of community pharmacy (UF-DSP)*
The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - transmission of documents to the Public Health Directorate.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/BRANCH PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis of issuing the operating authorization - relocation of headquarters/work 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.
*Establishment of distinct spaces within the structure of the closed-circuit pharmacy at a different address 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 different from that of the hospital or at the hospital's address, being coordinated by the pharmacy within the medical unit; it is mandatory to submit the operating authorization of the medical unit accompanied by the annex in which the pharmacy is specified.
*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 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 the relocation of the headquarters/operational point. Modifications must be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of modification.
*Authorization pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where registration is requested for the mention certifying authorization for sale and release through the information society of medicines granted without medical prescription/specific drugstore products.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to Pharmaceutical Units for the establishment of closed-circuit pharmacies - submission of documents to the Public Health Directorate.
*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.
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