Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
Available procedures
Voluntary suspension of the operating license of the pharmaceutical unit for a period of more than 30 calendar days (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where the suspension of the operating authorization is requested for justified reasons or for objective reasons invoked by the holder of the authorization, for a period between 30 days and 180 days (calendar days). The request for suspension of the authorization must be notified to the Ministry of Health - Directorate of Medicine Policy, Devices and Medical Technologies within 5 working days before the interruption of the activity.
IMPORTANT!!! All uploaded documents must be obligatorily named as follows: "pharmacy name_county name_**." (** represents the most concise description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Resumption of activity during the suspension period of the operating authorization or upon expiration of the period - SAME ADDRESS OF HEADQUARTERS/WORKING POINT (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where the addition of the mention regarding resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity is carried out at the same address of the headquarters/work point. Documents must be submitted 30 working days before the legal suspension period expires.
IMPORTANT !!! All uploaded documents must be named in the following mandatory format "pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
Modification of initial authorization conditions - Change of PHARMACEUTICAL UNIT MANAGER (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating license - change of the holder of the Operating License by the replacement of the head of the pharmaceutical unit. The changes must be notified to the Ministry of Health - Directorate of Medicine Policy, Medical Devices and Technologies within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be named obligatorily in the format "pharmacy name_county name_**." (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Cerere.pdf
Modification of initial authorization conditions - Change of authorization holder - Legal entity BY MERGER - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - change of holder of the Operating Authorization by modifying the legal entity (by absorption) and maintaining the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Pharmaceutical Directorate and Medical Devices within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be obligatorily named as follows "pharmacy name_county name_**.pdf" (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Establishment of a closed-circuit pharmacy (DSP-MS)*
The procedure is addressed to The County Public Health Directorates, respectively of Bucharest municipality for the establishment of closed circuit pharmacies - transmission of documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate. The resolution period (3 calendar days) represents the deadline for sending all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents must be obligatorily named in the format "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality sector 1), MARIAFARM_BV.pdf
Authorization of pharmacies/drugstores - ONLINE SALE (E-commerce) (DSP-MS)*
The procedure is addressed to the County Public Health Directorates, and the municipality of Bucharest, in situations where registration is requested for the mention certifying the authorization for sale and dispensing through the information society of medicines provided without medical prescription/specific products of drugstores - transmission of documents to the Ministry of Health - Directorate of Drug Policy, Devices and Medical Technologies.
The resolution period (3 calendar days) represents the time limit for transmitting all documents to the Ministry of Health
IMPORTANT !!! Uploaded documents must be named obligatorily as "pharmacy name_DSP_county name" ex.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality district 1), MARIAFARM_BV.pdf
*Resumption of activity during the period of suspension of the operating authorization or upon expiration of the interval - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (DSP-MS)*
The procedure is addressed to County Public Health Directorates, as well as the Bucharest municipality in situations where the registration of the resumption of activity during the suspension period or upon its expiration is requested. The resumption of activity is carried out at a different address of the headquarters/point of work compared to the initial one - transmission of documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate. The resolution term (3 calendar days) represents the term for transmitting all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents must be obligatorily named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, sector 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - Change of authorization holder - Legal entity BY AWARD (WITHIN THE ENFORCEMENT PROCEDURE) - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for the issuance of the operating authorization - change of holder of the Operating Authorization by amending the legal entity through adjudication (WITHIN THE FORECLOSURE PROCEDURE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Pharmaceutical and Medical Devices Directorate within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be named in the mandatory format “pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Cessation of pharmacy/drugstore activity - ONLINE SALE (Electronic commerce) (UF-MS)*
The procedure is addressed to pharmaceutical units in cases where the mention (on the operating authorization) of cessation of activity of selling and releasing, through the information society, medicines that are dispensed without a medical prescription/specific products of drugstores is requested.
IMPORTANT!!! All uploaded documents must obligatorily be named in the following format: "pharmacy name_county name_**." (** represents a very brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Voluntary suspension of the operating license of the pharmaceutical unit for a period of less than 30 calendar days (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where suspension of the operating authorization is requested for well-founded reasons or for objective reasons invoked by the holder of the authorization, for a period of less than 30 calendar days. The request to suspend the authorization must be notified to the Ministry of Health - Directorate for Drug Policy, Devices and Medical Technologies within 5 working days prior to the interruption of activity.
IMPORTANT!!! The uploaded document must be named as follows: "pharmacy name_county name."
Modification of initial authorization conditions - Change of authorization holder - Legal entity BY SALE AND PURCHASE - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that formed the basis of the issuance of the operating authorization - change of holder of the Operating Authorization through modification of the legal entity (by SALE-PURCHASE) and MAINTAINING THE ADDRESS where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of Medicine Policy, Medical Devices and Technologies within 5 working days from the date of the change.
IMPORTANT!!! All uploaded documents must be named in the following mandatory format "pharmacy name_county name_**." (** means a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Cessation of distinct spaces in the structure of the pharmacy with a closed circuit 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-MS)*
Distinct spaces designated for ensuring the supply of medicines to the sections or pavilions of healthcare units in whose structure they function, located at addresses different from the healthcare unit, as well as distinct spaces designated for the dispensing of medicines for outpatients within the national health programs, located at the same address or at a different address, may cease their activity by notifying the Ministry of Health in order to register the corresponding mention on the annex to the operating authorization of the coordinating pharmaceutical unit.
IMPORTANT!! All uploaded documents must be obligatorily named in the following format: "pharmacy name_county name_**." (** stands for the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Modification of initial authorization conditions - Change of authorization holder - Legal entity BY AWARD - SAME ADDRESS (UF-MS)*
The procedure addresses pharmaceutical units in situations where there are changes in the conditions that formed the basis for the issuance of the operating license - change of the holder of the Operating License by modifying the legal entity (through adjudication) and maintaining the address where the pharmaceutical unit operates. The changes must be notified to the Ministry of Health - Directorate of Pharmaceuticals and Medical Devices within 5 working days from the date of the change.
IMPORTANT !!! All uploaded documents must be named obligatorily in the format "pharmacy name_county name_**.pdf" (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Establishment of community pharmacy (DSP-MS)*
The procedure is addressed to County Public Health Directorates, and the municipality of Bucharest for the establishment of community pharmacies - sending documents to the Ministry of Health, Pharmaceutical and Medical Devices Directorate. The resolution term (3 calendar days) represents the period for sending all documents to the Ministry of Health.
IMPORTANT!!! The uploaded documents must be named mandatorily as "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality district 1), MARIAFARM_BV.pdf
*Establishment of a rural community office or seasonal office (DSP-MS)*
The procedure is addressed to the County Public Health Directorates, respectively that of the municipality of Bucharest, for the establishment of LOCAL OR SEASONAL DISTRIBUTION OFFICES - sending documents to the Ministry of Health, Pharmaceutical and Medical Devices Directorate.
The resolution period (3 calendar days) represents the deadline for sending all documents to the Ministry of Health.
IMPORTANT !!! The uploaded documents must be named in the following format: "pharmacy name_DSP_county name" ex.: ANAFARM_MB1.pdf (MB1 = Bucharest Municipality, sector 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (DSP-MS)*
The procedure is addressed to County Public Health Directorates, as well as the Bucharest municipality in the event of changes in the conditions that were the basis for issuing the operating authorization - relocation of headquarters/point of work - sending documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate.
The resolution time (3 calendar days) represents the deadline for sending all documents to the Ministry of Health
IMPORTANT !!! Uploaded documents must be named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, sector 1), MARIAFARM_BV.pdf
*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 (DSP-MS)*
The procedure is addressed to County Public Health Directorates, and the Bucharest municipality for setting up distinct spaces within the closed-circuit pharmacy structure at an address different from that of the hospital and/or distinct spaces for outpatient dispensing under the PNS, located at the same address or at a different address from the hospital - sending documents to the Ministry of Health - Directorate for Medicine Policy and Medical Devices. The resolution deadline (3 calendar days) represents the period for sending all documents to the Ministry of Health.
IMPORTANT!!! Uploaded documents must obligatorily be named in the format "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, sector 1), MARIAFARM_BV.pdf
*Correction of material errors entered on the Operating Authorization or within the mentions in the Annex to the authorization (UF-MS)*
The procedure is addressed to pharmaceutical units and targets situations where there are errors in the content of the Operating Authorization or in the annex (mentions) to it in relation to the documents submitted by the applicant.
The applicant will upload to the platform a request for the correction of incorrectly entered data, the Operating Authorization or its annex, as applicable, as well as the document supporting the correction of the material error.
IMPORTANT!!! The uploaded request must be compulsorily named as follows "pharmacy name_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, sector 1), MARIAFARM_BV.pdf
Modification of authorization conditions - CHANGES OF TRADE NAME, REGISTERED OFFICE ADDRESS, WORKING POINT ADDRESS ACCORDING TO NOMENCLATSTRADAL (UF-MS)*
The procedure addresses pharmaceutical units in situations where there are changes to the conditions that formed the basis for issuing the operating license in the following cases (not cumulative):
- change of commercial name (brand) for one or more pharmacy sales points
- change of registered office address without business activity
- change of postal address name in cases where the local council changes the street naming plan.
- change of registration number in the Trade Register
IMPORTANT!!! All uploaded documents must be named strictly as follows: "pharmacy name_county name_**." (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Authorization of community pharmacies for SEASONAL FLU VACCINATION ACTIVITY (UF-MS)*
The procedure is addressed to pharmaceutical units (authorized community pharmacies) that additionally request authorization for providing the vaccination service against seasonal flu by administering vaccines intended for the eligible population.
*Obtaining a duplicate of the operating authorization (UF-MS)*
The procedure refers to pharmaceutical units in case of loss of the operating license, for the purpose of obtaining a duplicate of it.
IMPORTANT!!! All uploaded documents must be named in the following format: "pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*
Voluntary cancellation of the operating authorization (UF-MS)*
The procedure is addressed to pharmaceutical units in cases where the CANCELLATION OF THE OPERATING AUTHORIZATION is requested when the pharmaceutical unit ceases activity. The documents must be submitted within 30 working days from the cessation of activity.
IMPORTANT !!! All uploaded documents must be named in the mandatory format "pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Abolition of rural community office if a community pharmacy is established in the rural locality/ Abolition of closed circuit office (UF-MS)*
The procedure is drawn up for situations where local distribution offices are closed when a community pharmacy is established in a rural locality. At the time of issuing the operating license for the newly established community pharmacy, the Ministry of Health notifies the holder of the operating license of the community pharmacy within which the office operates (art. 13, para. 5 of Law 266/2008, republished).
The procedure also applies to situations where a closed-circuit office is closed.
IMPORTANT!!! All uploaded documents must be obligatorily named in the format "pharmacy name_county name_**." (** represents the briefest possible description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Modification of initial authorization conditions - Change of authorization holder - Legal Entity BY DIVISION - SAME ADDRESS (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that formed the basis for the issuance of the operating authorization - change of holder of the Operating Authorization by modifying the legal entity (through division) and maintaining the address where the pharmaceutical unit operates. Changes must be notified to the Ministry of Health - Directorate of Pharmacy and Medical Devices within 5 working days from the date of the change.
IMPORTANT !!! All uploaded documents must be named in the following way: "pharmacy name_county name_**." (** stands for a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
Establishment of drugstore (DSP-MS)*
The procedure is addressed to the County Public Health Directorates, respectively the Bucharest municipality, for the establishment of drugstores - transmission of documents to the Ministry of Health, Pharmaceutical and Medical Devices Directorate. The resolution deadline (3 calendar days) represents the deadline for the transmission of all documents to the Ministry of Health
IMPORTANT !!! Uploaded documents must be named in the following format "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, sector 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - ANY MODIFICATION TO THE SPACE - Does not include the relocation of the headquarters/working point (DSP-MS)*
The procedure is addressed to County Public Health Directorates, and the Bucharest municipality in situations where there are changes to the conditions upon which the operating authorization was issued - any other modification made to the pharmaceutical unit's space, except for changing the headquarters/working point location - transmission of documents to the Ministry of Health - Pharmaceutical and Medical Devices Directorate. The resolution time (3 calendar days) represents the period for transmitting all documents to the Ministry of Health.
IMPORTANT !!! The uploaded documents must mandatorily be named as follows: "pharmacy name_DSP_county name" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, Sector 1), MARIAFARM_BV.pdf
Modification of initial authorization conditions - CHANGE OF PHARMACEUTICAL UNIT MANAGER NAME (UF-MS)*
The procedure is addressed to pharmaceutical units in cases where there are changes to the name of the head of the pharmaceutical unit - chief pharmacist, as a result of their marriage or divorce.
IMPORTANT!!! All uploaded documents must be named in the following format: "pharmacy name_county name_**." (** represents a brief description of the uploaded document) e.g.: ANAFARM_BV_Request.pdf
*Modification of initial authorization conditions - Change of authorization holder - DURING THE SUSPENSION PERIOD (UF-MS)*
The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that were the basis for issuing the operating authorization - change of holder of the Operating Authorization during the period when the Authorization is suspended.