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 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; it is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex in which the pharmacy is specified.
*Modification of initial authorization conditions -ANY CHANGE CONCERNING THE SPACE- Does not include relocation of the headquarters/work point (UF-DSP)*
The procedure is addressed to pharmaceutical units in the event that changes occur to the conditions that were the basis for granting the operating authorization - any other change made to the premises of the pharmaceutical unit, except for relocating the headquarters/branch. 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 change.
*Resumption of activity during the suspension period of the operating license or upon expiration of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where 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. The documents must be submitted 60 working days before the legal suspension period expires.
*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-unit chief-chief pharmacist or chief pharmacy assistant. The Ministry of Health, the Policy of Medicines and Medical Devices Directorate is also notified at the same time.
Modification of initial conditions authorization - RELOCATION OF HEADQUARTERS/BRANCH PHARMACEUTICAL UNIT (UF-DSP)*
Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying the authorization for sale and release through the information society of medicines granted without a medical prescription/specific drugstore products is requested.
*Establishment of a 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 submit on the platform the documents provided in Order MS 444/2019 - transmission of the documents to the DSP, preparation by the local DSP of the inspection report and of the compliance or non-compliance decision, and submission on the platform.
*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).
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