Public Health Directorate Buzau*
Available procedures
Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of chief drugstore-chief unit-pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicinal Policy and Medical Devices is also notified concurrently.
*Modification of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure addresses pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - relocation of headquarters/branch. The changes must be notified to the Ministry of Health - Directorate of Medicinal Policy and Medical Devices within 5 calendar 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 - sending documents to the Public Health Directorate.
*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 distinct areas within the closed-circuit pharmacy structure at an address different from that of the hospital and/or distinct areas for outpatient dispensing within the PNS, located at the same address or at a different address from 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 in the healthcare unit; the operating authorization of the healthcare unit must be obligatorily submitted, accompanied by the annex in which the pharmacy is provided.
*Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include the relocation of the headquarters/working 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 change made to 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 Medicines and Medical Devices Policy within 5 working days from the date of the change.
*Resumption of activity during the suspension period of the operating authorization 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 mention of 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 sent 60 calendar days before the expiration of the legal suspension period.
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 clinics, the manager of the medical unit submits the application accompanied by the requested documentation. The applicant shall upload on the platform the documents provided in Ord MS 444/2019 - transmission of documents to DSP, preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and submission on the platform.
*Pharmacy/drugstore authorization - ONLINE SALES (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 release through the information society of medicines that are granted without medical prescription/specific products for drugstores is requested.
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