Valcea 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 drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of the head drugstore-head pharmacist or head pharmacy assistant. The Ministry of Health, Directorate for Medicine Policy and Medical Devices, is also notified at the same time.
*Modification of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where there are changes in the conditions that were 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.
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the mention certifying the authorization for sale and dispensing through the information society of medicines granted without a medical prescription/specific products for drugstores is requested.
*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 DSP.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed circuit pharmacies serving healthcare units and/or outpatient clinics, the manager of the healthcare unit submits the request accompanied by the required documentation. The applicant will upload on the platform the documents provided for 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 uploading them on the platform.
*Establishment of distinct areas within the closed-circuit pharmacy structure at an address different from that of the hospital and/or distinct areas for outpatient dispensing within the NHP, 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 MODIFICATION TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where there are changes to the conditions underlying the issuance of the operating license - any other modification made to the premises of the pharmaceutical unit, except for the relocation of 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 modification.
Resumption of activity during the suspension period of the operating authorization or upon expiration of the interval - WITH CHANGE OF THE ADDRESS OF THE HEADQUARTERS/WORKING POINT (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the entry for resumption of activity is requested during the suspension period or at 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 suspension period.
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