Calarasi Public Health Directorate*
Available procedures
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for establishing chief drugstore unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices is also notified simultaneously.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure addresses 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 shall submit on the platform the documents provided for in Ord MS 444/2019 - transmission of documents to the DSP, preparation by the local DSP of the verification report and the conformity or non-conformity decision, and submission on the platform.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include moving the headquarters/branch (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions underlying the issuance of the operating license - any other modification made to the space of the pharmaceutical unit, except for relocating the headquarters/point of work. The changes must be notified to the Ministry of Health - Directorate of Medicine and Medical Devices Policy within 5 working days from the date of the change.
*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).
*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.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
Establishment of distinct spaces within 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 specified.
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where registration is requested for the mention attesting the authorization to sell and dispense, through the information society, medicines granted without a medical prescription/specific products for drugstores.
*Resumption of activity during the suspension period of the operating authorization or upon expiry of the period - WITH CHANGE OF THE REGISTERED OFFICE/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention for 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 period.
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