Maramures Public Health Directorate*
Available procedures
Establishment of community pharmacy (UF-DSP)*
The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - sending documents to the Public Health Directorate.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure addresses the establishment of closed-circuit pharmacies serving healthcare units and/or outpatient clinics, 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 Order MS 444/2019 - transmission of documents to the DSP, preparation by the local DSP of the verification report and of the compliance or non-compliance decision and submission on the platform.
Establishment of drugstore - unit chief - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of a head drugstore unit-head pharmacist or head pharmacy medical assistant. The Ministry of Health, Directorate of Drug Policy and Medical Devices is also notified simultaneously.
*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 in the conditions that formed the basis for issuing the operating authorization - relocation of headquarters/work point. The changes must be notified to the Ministry of Health - Directorate of Drug Policy and Medical Devices 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).
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention attesting the authorization of sale and release through the information society of medicines that are provided without a prescription/specific products for drugstores is requested.
*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 dispensing from the outpatient department 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 address being coordinated by the pharmacy within the healthcare unit; the operating authorization of the healthcare unit must be obligatorily submitted, accompanied by the annex in which the pharmacy is specified.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include relocation of headquarters/branch (UF-DSP)*
The procedure addresses pharmaceutical units in situations where there are changes to the conditions underlying the issuance of the operating authorization - any other change made to the premises of the pharmaceutical unit, except for moving the 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 license or upon expiration of the period - WITH CHANGE OF THE HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure applies to pharmaceutical units when requesting the registration of the mention of resumption of activity during the suspension period or upon its expiration. The resumption of activity is carried out at a different address for the headquarters/work point than the initial one. Documents must be submitted 60 working days before the expiration of the legal suspension period.
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