Bistrita-Nasaud Public Health Department*
Available procedures
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
Resumption of activity during the suspension period of the operating authorization or at the expiration of the interval - WITH CHANGE OF THE ADDRESS OF THE HEADQUARTERS/WORK POINT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the entry of the mention for resuming the activity is requested during the suspension period or upon its expiration. The resumption of activity is carried out at a different address for the headquarters/working point than the initial one. Documents are to be submitted 60 working days before the expiration of the legal suspension period.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure is aimed at establishing 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 the DSP, preparation by the local DSP of the verification report and the conformity or nonconformity decision, and submission on the platform.
*Establishment of a 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).
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where registration of the mention certifying the authorization to sell and dispense through information society means is requested for medicines that are granted without prescription/specific drugstore products.
*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 another address than that of the hospital (UF-DSP)*
The procedure targets the establishment of separate spaces within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or separate spaces for outpatient dispensing within the NHP, located at the same address or at a different address from that of the hospital.
*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.
*Modification of initial authorization conditions -ANY MODIFICATION TO THE SPACE - Does not include moving the headquarters/point of work (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions on which the operating license was granted - any other change made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/work point. The changes must be notified to the Ministry of Health - Directorate of Medicine and Medical Devices Policy within 5 working days from the date of the change.
*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 in the conditions that formed the basis for issuing the operating authorization-relocation of headquarters/branch. 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.
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