Mehedinti 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 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 Ord MS 444/2019 - transmission of documents to the DSP, preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and submission on the platform.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (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 authorization - relocation of headquarters/working point. The changes must be notified to the Ministry of Health - Directorate of Drug Policy and Medical Devices within 5 working days from the date of the modification.
*Setting up 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 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 provided.
*Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include moving the headquarters/work point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions based on which the operating authorization was issued - any other change made to the space of the pharmaceutical unit, except for relocating the headquarters/branch. 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 change.
*Resumption of activity during the suspension period of the operating license or upon expiry of the interval - WITH CHANGE OF HEADQUARTERS/WORK POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the request is made to register the mention of resumption of activity 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 must be submitted 60 working days before the expiration of the legal activity 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 - sending documents to DSP.
Establishment of community pharmacy (UF-DSP)*
The procedure addresses Pharmaceutical Units for the establishment of community pharmacies - sending documents to the Public Health Directorate.
*Pharmacy/drugstore authorization - ONLINE SALE (Electronic Commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention certifying the authorization for sale and dispensing of medicines granted without medical prescription/specific drugstore products through the information society is requested.
*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-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.
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