Salaj Public Health Directorate*
Available procedures
Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies serving healthcare units and/or outpatient clinics. The manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will upload on the platform the documents provided in Order MS 444/2019 - submission of documents to the Public Health Directorate (DSP), preparation by the local DSP of the inspection report and of the decision of compliance or non-compliance, and uploading them on the platform.
*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 the one 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 SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention attesting the authorization for sale and release through the information society of medicines that are provided without a medical prescription/specific drugstore products is requested.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of the drugstore - head unit - chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Department of Medicine Policy and Medical Devices, is also notified simultaneously.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORK POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - relocation of headquarters/branch. The changes must be notified to the Ministry of Health - Directorate of Medicinal 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 headquarters/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for the relocation of the headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Pharmaceutical Policy and Medical Devices within 5 working days from the date of the modification.
*Resumption of activity during the suspension period of the operating authorization or at the end 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 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 sent 60 working days before the legal term for suspension of activity expires.
*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.
Establishment of community pharmacy (UF-DSP)*
The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - sending inline-documents to the Public Health Directorate.
*