Satu Mare Public Health Directorate*
Available procedures
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 of unit - chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate for Medicinal Policy and Medical Devices is notified simultaneously.
*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 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 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 a different address from that of the hospital (UF-DSP)*
The procedure is intended for pharmaceutical units that wish to establish closed circuit pharmacies at an address other than that of the hospital or at the hospital's address, coordinated by the pharmacy within the healthcare unit. The operating license of the healthcare unit must be obligatorily submitted, accompanied by the annex in which the pharmacy is specified.
*Resumption of activity during the suspension period of the operating license or upon expiration of the interval - WITH CHANGE OF THE ADDRESS OF THE HEADQUARTERS/WORKING POINT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the entry 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/branch compared to the initial one. Documents must be submitted 60 working days before the legal suspension period expires.
*Establishment of community pharmacy (UF-DSP)*
The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - sending documents to the Public Health Department.
*Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of the headquarters/work point (UF-DSP)*
The procedure is addressed to pharmaceutical units in the event of changes to the conditions that formed the basis for issuing the operating authorization - any other modification to the pharmaceutical unit's premises, except for relocating the headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicines Policy and Medical Devices within 5 working days from the date of the modification.
Pharmacies/drogeries authorization - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure addresses pharmaceutical units in the situation where the registration of the mention that attests the authorization for sale and release through the information society of medicines granted without a medical prescription/specific products of drugstores is requested.
Establishment of local distribution office (UF-DSP)*
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 requested documentation. The applicant will upload to the platform the documents provided for in Order MS 444/2019 - the transmission of documents to the DSP, the preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and the submission on the platform.
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