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Constanta Public Health Directorate*

Available procedures

PROCEDURA

Companii

National

Establishment of a closed-circuit pharmacy (UF-DSP)*

The procedure addresses 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 – forwarding the documents to the DSP, the preparation by the local DSP of the verification report and the decision of conformity or non-conformity, and submission on the platform.

PROCEDURA

Companii

National

Modification of initial authorization conditions - MOVING HEADQUARTERS/WORKING POINT PHARMACEUTICAL UNIT (UF-DSP)*

The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions on which the operating authorization was issued - 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 change.

PROCEDURA

Companii

National

Establishment of distinct spaces in 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)*

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 dispensing in the outpatient department within the PNS, located at the same address or at a different address from that of the hospital (UF-DSP).

PROCEDURA

Companii

National

Pharmacy/drugstore authorization - ONLINE SALE (E-commerce) (UF-DSP)*

The procedure is addressed to pharmaceutical units in cases where the inscription certifying the authorization for sale and release through the information society of medicines dispensed without a medical prescription/specific products for drugstores is requested.

PROCEDURA

Companii

National

Specialized public health assistance notification – AFIR Project – urgent*

The notification of specialized public health assistance of conformity represents the technical document issued in writing by the competent authority, which establishes the requirements of the legal provisions in force regarding hygiene and public health for the placement, arrangement, construction, or modification for the operation of a unit that carries out an activity with risk to the health of the population; This notification is issued based on specific documentation developed by the designer in accordance with current legislation.

In situations where DSPJ Constanța considers that additions or modifications to the documentation are necessary, C.A.U. analyzes the remarks in question and the way they influence the technical conditions imposed by other approvals and lead to the modification of the solution, communicating these aspects to the C.A.U. Secretariat, which forwards the requests for modifications or updates to the documentation to the applicant in writing.

The applicant for the unique approval pays the corresponding fee at the city hall cashier or through https://www.ghiseul.ro/ghiseul/public , into the specialized assistance account RO97TREZ 2310E 3650 00XXXX opened at the Constanța treasury. Proof of electronically signed payment is attached to the documentation for the issuance of the unique approval. The fee goes into a collector account (mandate amounts) from which it is transferred to DSPJ Constanța within a maximum of 24 hours from receipt.

There are no public registers within the institution for this procedure.
The procedure is not posted on the institution's website.

PROCEDURA

Companii

National

Notification of specialized assistance in public health – AFIR Project*

The specialized public health compliance assistance notification represents the technical document issued in writing by the competent authority which establishes the requirements of the current legal provisions regarding hygiene and public health for the placement, arrangement, construction, or modification for the operation of a unit carrying out an activity with health risk for the population; This notification is issued based on specific documentation prepared by the designer in accordance with the legislation in force.

In cases where DSPJ Constanța considers it necessary to add or modify the documentation, C.A.U. analyzes the observations in question and how they affect the technical conditions imposed by other approvals and lead to solution changes, communicating these aspects to the C.A.U. Secretariat, which sends the applicant in writing the requests for changes or updates to the documentation.

The single approval applicant pays the corresponding fee at the city hall cashier or via https://www.ghiseul.ro/ghiseul/public, to the specialized assistance account RO97TREZ 2310E 3650 00XXXX opened at Constanța Treasury. The electronically signed proof of payment is attached to the documentation for the issuance of the single approval. The fee enters a collector account (mandate amounts) from where it is transferred to DSPJ Constanța within a maximum of 24 hours from receipt.

There are no public registries within the institution for this procedure.

The procedure is not posted on the institution's website.

PROCEDURA

Companii

National

Establishment of community pharmacy (UF-DSP)*

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

PROCEDURA

Companii

National

Establishment of drugstore - unit manager - chief pharmacist or chief pharmacy medical assistant (UF-DSP)*

The procedure is addressed to drugstores for the establishment of the drugstore-chief unit-chief pharmacist or chief pharmacy assistant. The Ministry of Health, Directorate for the Policy of Medicine and Medical Devices, is notified simultaneously.

PROCEDURA

Companii

National

Resumption of activity during the suspension period of the operating license or at the expiration of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*

The procedure is addressed to pharmaceutical units in cases where the registration of the mention regarding the resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity is carried out at a different address of the headquarters/secondary office than the initial one. The documents are to be submitted 60 working days before the expiration of the legal period of suspension of activity.

PROCEDURA

Companii

National

Establishment of rural community office/seasonal office (UF-DSP)*

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

PROCEDURA

Companii

National

Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include moving headquarters/branch (UF-DSP)*

The procedure is addressed to pharmaceutical units in situations where there are changes in the conditions that formed the basis for the issuance of the operating authorization - any other modification made to the space of the pharmaceutical unit, except for the relocation of the headquarters/work point. The changes must be notified to the Ministry of Health - Directorate for Medicines Policy and Medical Devices within 5 working days from the date of the change.

PROCEDURA

Companii

National

Specialized public health emergency assistance notification*

The notification of specialized public health assistance for compliance represents the technical document issued in writing by the competent authority which sets the requirements of the legal provisions in force regarding noted hygiene and public health when locating, arranging, constructing, or modifying for the operation of a unit that carries out an activity with a risk to the health of the population; This notification is issued based on the specific documentation prepared by the designer in accordance with the legislation in force.

In situations where DSPJ Constanța considers it necessary to supplement or modify the documentation, C.A.U. analyzes the observations in question and how they impact the technical conditions imposed by other approvals and lead to changes in the solution, communicating these aspects to the Secretariat of C.A.U., which sends the applicant in writing the requests for modifications or updates of the documentation.

The unique approval applicant pays the corresponding fee at the city hall cashier's office or through https://www.ghiseul.ro/ghiseul/public, into the specialized assistance account RO97TREZ 2310E 3650 00XXXX opened at Constanța Treasury. The electronically signed payment proof is attached to the documentation for issuing the unique approval. The fee is deposited into a collector account (mandate sums) from where it is transferred to DSPJ Constanța within a maximum of 24 hours from receipt.

There are no public registries within the institution for this procedure.
The procedure is not posted on the institution's website.

PROCEDURA

Companii

National

Specialized public health assistance notification*

The notification for specialized public health assistance of compliance represents the technical document issued in writing by the competent authority, by which the requirements of the legal provisions in force regarding hygiene and public health are established for the location, arrangement, construction, or modification for the operation of a unit that carries out an activity with risk to the health of the population;

This notification is issued based on specific documentation prepared by the designer in accordance with the legislation in force.

In situations where DSPJ Constanța considers that additions or modifications to the documentation are necessary, C.A.U. analyzes the observations in question and how these influence the technical conditions imposed by other approvals and lead to the modification of the solution, communicating these aspects to the Secretariat of C.A.U., which forwards the requests for changes or updates to the documentation to the applicant in writing.

The unified approval applicant pays the corresponding fee at the city hall's cashier or via https://www.ghiseul.ro/ghiseul/public, into the specialized assistance account RO97TREZ 2310E 3650 00XXXX, opened at the Constanța treasury. Proof of electronic payment is attached to the documentation for the issuance of the unified approval. The fee goes into a collector account (mandate sums) from where it is transferred to DSPJ Constanța within a maximum of 24 hours from receipt.

There are no public registers within the institution for this procedure.
The procedure is not posted on the institution’s website.

Constanta Public Health Directorate*

Str. Aleea Lacramioarei nr. 1

Telefon: 0241.83.83.30

Fax: 0241.83.94.61;

Email: administrativ@dspct.ro

www.dspct.ro

Assistance services

There are no Assistance services registered by this institution

Institutional structure

CAU Direcția de Sănătate Publică Constanta

Compartiment de supraveghere si control boli transmisibile

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