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 that serve health units and/or outpatient clinics, the manager of the health unit submits the application accompanied by the required documentation. The applicant will upload on the platform the documents provided in Ord MS 444/2019 - submission of documents to the DSP, preparation by the local DSP of the verification report and the decision of compliance or non-compliance and uploading them on the platform.
*Establishment of separate spaces within the structure of the closed-circuit pharmacy at a different address from that of the hospital and/or separate 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 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 pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where registration is requested for the mention certifying the authorization for sale and release via the information society of medicines granted without prescription/specific products for drugstores.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for establishment of chief drugstore unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Directorate of Medicine Policy and Medical Devices is also notified simultaneously.
*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 to the conditions that formed the basis for the issuance of the operating authorization - relocation of headquarters/working point. 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 relocation of the 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 license - any other change made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/branch. The changes must be notified to the Ministry of Health - Directorate for Medicinal Policy and Medical Devices within 5 working days from the date of the change.
*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 registration of the resumption of activity is requested during the suspension period or at its expiration. The resumption of activity takes place at a different address for the headquarters/working point than the initial one. The documents must 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 - 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.
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