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 request accompanied by the required documentation. The applicant will submit on the platform the documents provided for in Order MS 444/2019 - sending the documents to the DSP, preparation by the local DSP of the inspection report and the conformity or non-conformity decision and submitting these 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/work point. 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.
*Establishment of distinct areas within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or distinct areas 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 different from that of the hospital, or at the hospital’s address but coordinated by the pharmacy within the healthcare unit; the operating authorization of the healthcare unit must be submitted compulsorily, 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/work point (UF-DSP)*
The procedure applies to pharmaceutical units in situations where changes occur in 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/place of business. 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.
*Resuming activity during the suspension period of the operating authorization or at the expiration of the period - WITH CHANGE OF HEADQUARTERS/WORKING LOCATION ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention of resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity is carried out at a different address of the headquarters/working point compared to the initial one. The documents must be submitted 60 working days before the expiration of the legal suspension period.
*Establishment of a 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.
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 Directorate.
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the note certifying the authorization for sale and dispensing through the information society of medicines that are granted without a medical prescription/specific products for drugstores is requested.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for establishing a drugstore-chief unit-chief pharmacist or chief pharmacy assistant. The Ministry of Health, Directorate for Medicine Policy and Medical Devices, is also notified simultaneously.
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