Timis Public Health Directorate*
Available procedures
Establishment of a drugstore - unit head - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*
The procedure is addressed to drugstores for establishing chief drugstore unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, the Directorate of Medicine Policy and Medical Devices, is also notified simultaneously.
*Establishment of distinct areas within the structure of the closed-circuit pharmacy 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 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 of the sanitary unit; the operating authorization of the sanitary unit must be obligatorily submitted, accompanied by the annex in which the pharmacy is specified.
*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.
*Modification of initial authorization conditions - RELOCATION OF HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where there are changes to 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 for Medicine Policy and Medical Devices within 5 working days from the date of the modification.
*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 Ord MS 444/2019 – sending the documents to the DSP, preparation by the local DSP of the inspection report and the decision of compliance or non-compliance, and submission on the platform.
*Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of the headquarters/working point (UF-DSP)*
The procedure is intended for pharmaceutical units in situations where there are changes to the conditions that formed the basis for the issuance of the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/working point. 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 modification.
*Pharmacy/drugstore authorization - ONLINE SALES (e-Commerce) (UF-DSP)*
The procedure is addressed to pharmaceutical units in cases where the entry certifying authorization for sale and dispensing via the information society of medicines granted without a medical prescription/specific drugstore products is requested.
*Resumption of activity during the suspension period of the operating authorization or at the end of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*
The procedure is addressed to pharmaceutical units in the situation where the registration of the resumption of activity is requested during the suspension period or upon its expiration. The activity is resumed at a different address of the headquarters/working point than the initial one. The documents are submitted 60 working days before the expiration of the legal suspension period.
*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 Department (DSP).