Arad Public Health Directorate*

The procedure is addressed to Pharmaceutical Units for the establishment of community pharmacies - submission of documents to the Public Health Directorate.

The procedure is addressed to pharmaceutical units in cases where there are changes in the conditions that formed the basis for issuing the operating license - relocation of headquarters/working point. The changes must be notified to the Ministry of Health - Directorate for Medicinal Policy and Medical Devices within 5 working days from the date of the change.

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 of the healthcare unit; the operating authorization of the healthcare unit must be submitted, accompanied by the annex in which the pharmacy is provided.

The procedure is addressed to pharmaceutical units in situations where registration of the mention attesting authorization to sell and release medicinal products granted without medical prescription/specific drugstore products through the information society is requested.

The procedure is addressed to pharmaceutical units in cases where the registration of the mention of resuming 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 are to be submitted 60 working days before the legal suspension period expires.

”Certification of compliance with hygiene and public health standards applies, at the request of the activity holder, for the assessment of compliance with legal regulations regarding public health for operational objectives that carry out activities with risk to the health of the population”.

Specialized public health assistance is the administrative-professional procedure by which, upon request, individuals or legal entities are informed about the manner of fulfilling the requirements of the legal provisions in force regarding hygiene and public health in the placement, arrangement, construction, and modification for the operation of a unit that carries out an activity with risk to the health of the population.

Free practice authorization.

Registration in the unique register of offices.

”The sanitary authorization for operation based on the evaluation report is the administrative procedure by which the competent authority evaluates the compliance of the objective, prepares the evaluation report, and issues the sanitary authorization for operation or the notification of its rejection.”

”Sanitary authorization for operation based on the evaluation report is the administrative procedure by which the competent authority evaluates the conformity of the objective, prepares the evaluation report, and issues the sanitary authorization for operation or the notification of its rejection”.

”The sanitary authorization of operation based on the evaluation report is the administrative procedure by which the competent authority assesses the compliance of the objective, prepares the evaluation report and issues the sanitary authorization of operation or the notification of its rejection.”

Specialist public health assistance is the administrative-professional procedure by which, upon request, natural or legal persons are informed about the manner of fulfilling the requirements of the legal provisions in force regarding hygiene and public health in the placement, arrangement, construction, and modification for the operation of a unit that carries out an activity with risk to the health of the population."

”The sanitary authorization of operation based on the evaluation report is the administrative procedure by which the competent authority assesses the compliance of the objective, prepares the evaluation report, and issues the sanitary authorization of operation or the notification of its rejection.”

Specialized public health assistance is the administrative-professional procedure by which, upon request, individuals or legal entities are informed about how the requirements of the legal provisions in force regarding hygiene and public health are fulfilled during the placement, arrangement, construction, and modification for the operation of a unit that carries out an activity with risk to the health of the population.

The procedure is intended for 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 specified in Ord MS 444/2019 - transmission of documents to the DSP, preparation by the local DSP of the verification report and the compliance or non-compliance decision, and submission on the platform.

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 changes made to the pharmaceutical unit's space, except for relocation of the headquarters/work point. 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 change.

Specialized public health assistance is the administrative-professional procedure by which, upon request, individuals or legal entities are informed about the way to fulfill the requirements of the legal provisions in force regarding hygiene and public health in the placement, layout, construction, and modification for the operation of a unit that carries out an activity with risks to the health of the population.

"The certification of compliance with hygiene and public health standards is applied, at the request of the activity holder, for the purpose of assessing compliance with legal regulations regarding public health for operational objectives that carry out activities at risk for the population's health."

"The sanitary operating authorization based on the evaluation report is the administrative procedure by which the competent authority assesses the compliance of the objective, prepares the evaluation report, and issues the sanitary operating authorization or the notification of its rejection."

Specialist public health assistance is the administrative-professional procedure by which, upon request, individuals or legal entities are informed about the manner of fulfilling the requirements of the legal provisions in force regarding hygiene and public health in the placement, arrangement, construction, and modification for the operation of a unit that carries out an activity with risk to the health of the population.

The procedure addresses drugstores for the establishment of chief drugstore unit-chief pharmacist or chief pharmacy medical assistant. The Ministry of Health, Directorate of Medicine Policy and Medical Devices, is also notified at the same time.

The procedure is addressed to pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - submission of documents to the Public Health Directorate.

Specialized public health assistance is the administrative-professional procedure through which, upon request, individuals or legal entities are informed about the manner of fulfilling the requirements of the legal provisions in force regarding hygiene and public health when locating, arranging, constructing, and modifying for the operation of a unit that carries out an activity with a risk to the health of the population.

”The sanitary authorization of operation based on the evaluation report is the administrative procedure by which the competent authority assesses the compliance of the objective, draws up the evaluation report, and issues the sanitary authorization of operation or the notification of its rejection.”

”The sanitary authorization based on a declaration on one's own responsibility is the administrative procedure by which the competent authority registers the declaration on one's own responsibility regarding the compliance with the legal regulations applicable to the field and is notified and requested to verify conformity.”

"The sanitary operating authorization based on the evaluation report is the administrative procedure by which the competent authority assesses the conformity of the objective, prepares the evaluation report, and issues the sanitary operating authorization or the notification of its rejection."

”The sanitary authorization for operation based on the evaluation report is the administrative procedure whereby the competent authority assesses the compliance of the objective, prepares the evaluation report, and issues the sanitary authorization for operation or the notification of its rejection.”

”The sanitary operating authorization based on the evaluation report is the administrative procedure through which the competent authority assesses the compliance of the objective, prepares the evaluation report, and issues the sanitary operating authorization or the notification of its rejection.”