Tulcea Public Health Directorate*
Available procedures
Modification of initial conditions for authorization - MOVING HEADQUARTERS/WORK 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 within the healthcare unit; it is mandatory to submit the operating authorization of the healthcare unit accompanied by the annex specifying the pharmacy.
*Resumption of activity during the suspension period of the operating license or upon expiry of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure addresses pharmaceutical units in situations where a request is made to register the mention of resumption of activity during the suspension period or upon its expiration. The resumption of activity takes place at a different address of the headquarters/branch compared to the initial one. The documents are submitted 60 working days before the expiration of the legal suspension period.
*Establishment of community pharmacy (UF-DSP)*
The procedure addresses Pharmaceutical Units for the establishment of community pharmacies - submission of documents to the Public Health Directorate.
*Establishment of closed-circuit pharmacy (UF-DSP)*
The procedure is addressed to the establishment of closed-circuit pharmacies serving healthcare units and/or outpatient clinics. The manager of the healthcare unit submits the request accompanied by the required documentation. The applicant must upload on the platform the documents specified in Ord MS 444/2019 - transmission of documents to the DSP, preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and submission on the platform.
*Modification of initial authorization conditions -ANY MODIFICATION TO THE SPACE- Does not include the relocation of the headquarters/branch (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 relocation of the headquarters/work point. Changes are to be notified to the Ministry of Health - Directorate of Medicine Policy and Medical Devices within 5 working days from the date of the change.
*Establishment of drugstore - unit chief - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for the establishment of chief drugstore-chief unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Drug Policy Directorate, and Medical Devices are simultaneously notified.
*Authorization for pharmacies/drugstores - ONLINE SALE (E-commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where the registration of the mention attesting authorization for sale and release through the information society of medicines granted without medical prescription/specific products for drugstores is requested.
*Establishment of a 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.