Botosani Public Health Directorate*
Available procedures
Change of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in the event of changes to the conditions that formed the basis for granting the operating authorization - relocation of headquarters/work point. 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 suspension period of the operating authorization or upon expiration of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases 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 than the initial one. The documents are to be submitted 60 working days before the expiration of the legal suspension term.
*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, the Directorate of Drug Policy and Medical Devices is also notified at the same time.
*Establishment of distinct spaces in the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or distinct spaces for dispensing from the outpatient clinic within the PNS, located at the same address or at a different address from that of the hospital (UF-DSP)*
Modification of initial authorization conditions -ANY CHANGE TO THE SPACE- Does not include relocation of the headquarters/branch (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 - any other change made to the premises of the pharmaceutical unit, except for relocating the headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicinal Policy and Medical Devices within 5 working days from the date of the change.
*Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
Standard request to DSP*
According to Model no. 2 from the annex to the Rules regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019.
- The document is downloaded, filled out, and then uploaded to the platform, signed with an extended electronic signature.
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Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure addresses the establishment of closed-circuit pharmacies that serve medical units and/or outpatient clinics; the manager of the medical unit submits the application accompanied by the required documentation. The applicant will submit on the platform the documents provided in Ord MS 444/2019 - sending the documents to the DSP, preparation by the local DSP of the verification report and the compliance or non-compliance decision, and submission 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 OFFICINES - submission of documents to DSP.
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