Bihor 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 NHP, located at the same address or at a different address from that of the hospital (UF-DSP)*
Pharmacy/drugstore authorization - ONLINE SALE (E-commerce) (UF-DSP)*
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*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a drugstore - unit chief - chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices, is also notified at the same time.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where modifications occur to the conditions that formed the basis for issuing the operating authorization - change of headquarters/branch. The 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.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of the headquarters/operational point (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where there are changes in the conditions that formed the basis for the issuance of the operating authorization - any other modification affecting the premises of the pharmaceutical unit, except for the relocation of the headquarters/point of work. 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 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 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 authorization or upon 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 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 are to be submitted 60 working days before the expiration of the legal suspension period.
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