Timis Public Health Directorate*
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 a chief drugstore unit - chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate for Medicine and Medical Devices Policy, is also notified simultaneously.
*Establishment of distinct spaces within the structure of the closed-circuit pharmacy at a different address than that of the hospital and/or distinct spaces for outpatient dispensing within the PNS, located at the same address or at a different 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 address, being coordinated by the pharmacy in the healthcare unit; it is mandatory to submit the operating license of the healthcare unit accompanied by the annex in which the pharmacy is provided.
*Establishment of community pharmacy (UF-DSP)*
The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - submitting documents to the Public Health Directorate.
*Modification of initial authorization conditions - CHANGE OF HEADQUARTERS/BRANCH OF PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating authorization - relocation of 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.
*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 clinics; the manager of the healthcare unit submits the application accompanied by the required documentation. The applicant will submit on the platform the documents provided in Order MS 444/2019 - the transmission of the documents to the DSP, the preparation by the local DSP of the verification report and the decision of compliance or non-compliance, and the submission on the platform.
*Modification of initial authorization conditions - ANY CHANGE REGARDING THE SPACE - Does not include moving the headquarters/working point (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions on which the operating authorization was issued - any other modification made to the space of the pharmaceutical unit, except for the 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.
*Authorization of pharmacies/drugstores - ONLINE SALE (Electronic commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where registration is requested for the mention certifying the authorization for sale and dispensing through the information society of medicines that are provided without a medical prescription/specific products for drugstores.
*Resumption of activity during the suspension period of the operating license or upon expiration of the period - WITH CHANGE OF ADDRESS OF THE HEADQUARTERS/WORKING POINT (UF-DSP)*
The procedure is addressed to pharmaceutical units in situations where 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 must be submitted 60 working days before the legal suspension period expires.
*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).