Arges 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 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 other than that of the hospital or at the hospital's address being coordinated by the pharmacy within the healthcare unit; it is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is specified.
*Authorization of pharmacies/drugstores - ONLINE SALES (Electronic Commerce) (UF-DSP)*
The procedure applies to pharmaceutical units in situations where registration of the mention attesting the authorization for sale and release through the information society of medicines granted without medical prescription/specific products for drugstores is requested.
*Resumption of activity during the suspension period of the operating authorization or upon expiration of the period - WITH CHANGE OF THE ADDRESS OF THE HEADQUARTERS/WORK POINT (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the registration of the mention of resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity is carried out 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.
*Establishment of local distribution office (UF-DSP)*
The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - sending 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 drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of drugstore-chief unit-chief pharmacist or chief pharmacy assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.
*Establishment of closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies that serve healthcare units and/or outpatient clinics; the manager of the healthcare unit submits the application accompanied by the requested documentation. The applicant will upload on the platform the documents provided in Order MS 444/2019 - transmission of documents to DSP, preparation by the local DSP of the verification report and the decision of conformity or nonconformity, and uploading them on the platform.
Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT FOR 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/secondary unit. 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 change.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include moving the headquarters/work point (UF-DSP)*
The procedure applies to pharmaceutical units in situations where there are changes in the conditions based on which the operating authorization was granted - any other change affecting the premises of the pharmaceutical unit, except for the relocation of the headquarters/point of work. 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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