Brasov Public Health Directorate*
Available procedures
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
Establishment of a rural/seasonal community 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).
*Modification of initial authorization conditions - CHANGE OF HEADQUARTERS/WORK POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur regarding the conditions on which the operating authorization was issued - relocation of headquarters/branch. The 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.
*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 department within the PNS, located at the same address or at another address than 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 medical unit; it is mandatory to submit the operating authorization of the medical unit accompanied by the annex in which the pharmacy is stated.
*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 there are changes in the conditions that formed the basis for the issuance of the operating authorization - any other modification concerning the space of the pharmaceutical unit, except for the relocation of the headquarters/branch. The 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 of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where the registration of the mention certifying the authorization for sale and dispensing through the information society of medicines granted without medical prescription/specific products of drugstores is requested.
*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)*
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.
*Establishment of a closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies serving medical units and/or outpatient departments, the manager of the medical unit submits the application accompanied by the required documentation. The applicant shall 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.
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