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 chief drugstore unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified at the same time.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (PU-CHA)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - relocation of headquarters/branch. Changes must be notified to the Ministry of Health - Drug Policy and Medical Devices Directorate within 5 working days from the date of the change.
*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 of the healthcare unit. The operating authorization of the healthcare unit must be obligatorily submitted, accompanied by the annex in which the pharmacy is provided.
*Resumption of activity during the suspension period of the operating authorization or upon expiry of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in the case where the mention of resuming activity is requested during the suspension period or at 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 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.
*Change 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 there are changes to the conditions that formed the basis for issuing the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/point of work. The 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 modification.
Authorization of pharmacies/drugstores - ONLINE SALES (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying authorization for sale and release via the information society of medicines granted without a medical prescription/specific products for 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 that serve medical units and/or outpatient clinics; the manager of the medical unit submits the application accompanied by the required documentation. The applicant will submit 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 the compliance or non-compliance decision, and their submission on the platform.
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