Cluj-Napoca Public Health Directorate*
Available procedures
Establishment of distinct spaces within the structure of the pharmacy with a closed-circuit at an address different from that of the hospital and/or distinct spaces for dispensing from outpatient care 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 of 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 SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the mention attesting the authorization for sale and dispensing 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 HEADQUARTERS/WORKING POINT ADDRESS (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 at its expiration. The resumption of activity takes place at a different address of the headquarters/branch than the initial one. The 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 - submission of documents to the Public Health Directorate.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure addresses the establishment of 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 - the transmission of documents to the Public Health Directorate (DSP), preparation by the local DSP of the verification report and the conformity or non-conformity decision, and submission on the platform.
*Modification of initial licensing conditions - MOVE OF HEADQUARTERS/WORK POINT OF PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that were the basis for issuing the operating authorization - relocation of headquarters/branch. 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.
*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.
*Setting up a drugstore - unit manager - chief pharmacist or chief pharmacy 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, the Directorate for Drug and Medical Device Policy is also notified at the same time.
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