Bihor Public Health Directorate*
Available procedures
Establishment of distinct spaces in 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)*
Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
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*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-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Drug and Medical Device Policy is also notified simultaneously.
*Modification of initial authorization conditions - CHANGE OF HEADQUARTERS/WORK POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure addresses pharmaceutical units in situations where changes occur in the conditions that formed the basis for the issuance of the operating permit - relocation of headquarters/work 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 MODIFICATION TO THE SPACE - Does not include relocation of the headquarters/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur to the conditions that formed the basis for granting the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/place of business. 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 modification.
*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 Public Health Directorate (DSP).
*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.
*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.
Resumption of activity during the suspension period of the operating permit or upon expiration of the period - WITH CHANGE OF ADDRESS OF THE HEADQUARTERS/WORK POINT (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/operating point than the initial one. The documents must be submitted 60 working days before the expiration of the legal suspension period.
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