Calarasi Public Health Directorate*
Available procedures
Setting up a drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a chief drugstore unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Directorate of Medicine Policy and Medical Devices, is simultaneously notified.
*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 services. The manager of the healthcare unit submits the application accompanied by the requested documentation. The applicant will submit on the platform the documents provided in Ord MS 444/2019 – transmission of documents to the DSP, preparation by the local DSP of the verification report and the decision of conformity or non-conformity, and submission on the platform.
*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 situations where changes occur in the conditions that formed the basis for issuing the operating authorization - any other modification made to the space of the pharmaceutical unit, except for relocation of the headquarters/working 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 modification.
*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 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 separate spaces within the structure of the closed-circuit pharmacy at an address different from that of the hospital and/or separate spaces for outpatient dispensing within the NCP, 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 within 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.
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where registration of the mention certifying authorization for sale and release through the information society of medicines granted without prescription/specific products for drugstores is requested.
*Resumption of activity during the suspension period of the operating license or at the end of the period - WITH CHANGE OF THE HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the resumption of activity 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 are submitted 60 working days before the expiration of the legal suspension period.
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