Mures Public Health Directorate*
Available procedures
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 distinct spaces within the closed-circuit pharmacy structure 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 address, being coordinated by the pharmacy in the sanitary unit; it is mandatory to submit the operating authorization of the sanitary unit accompanied by the annex in which the pharmacy is specified.
*Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/working point (UF-DSP)*
The procedure applies to pharmaceutical units in cases 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 relocating the headquarters/point of work. 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.
*Resumption of activity during the operating license suspension period or at the expiration of the period - WITH CHANGE OF THE HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention of activity resumption 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 submitted 60 working days before the expiration of the legal suspension period.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of chief drugstore-chief unit-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 PHARMACEUTICAL UNIT (UF-DSP)*
Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where registration of the mention certifying authorization for sale and dispensation through the information society of medicines granted without medical prescription/specific drugstore products is requested.
*Establishment of closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies that serve 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 Ord MS 444/2019 – sending the documents to the DSP, the preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and posting on the platform.
*Establishment of a local distribution office (UF-DSP)*
The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - sending documents to DSP.
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