Botosani Public Health Directorate*
Available procedures
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 to the conditions on which the operating license was issued - relocation of headquarters/branch. The changes must be notified to the Ministry of Health - Policy of Medicines and Medical Devices Directorate 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 cases where the registration of the resumption of activity note is requested 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 suspension period.
*Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for establishing drugstore-chief unit-pharmacist chief or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices, is also notified simultaneously.
*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 outpatient dispensing within the PNS, located at the same address or at a different address from the hospital (UF-DSP)*
Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of the headquarters/branch (UF-DSP)*
The procedure addresses pharmaceutical units in situations where there are changes to the conditions that were the basis for granting the operating authorization - any other change made to the space of the pharmaceutical unit, except for moving the headquarters/working 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.
*Authorization pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
Request form to DSP*
According to Model no. 2 from the annex to the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019.
- Download the document, fill it in, and then upload it to the platform, signed with an extended electronic signature.
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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 requested documentation. The applicant will upload on the platform the documents provided in Order MS 444/2019 – submission of documents to the Public Health Directorate (DSP), the preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and the upload 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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