Botosani Public Health Directorate*
Available procedures
According to Model no. 2 from the annex to the Rules regarding the establishment, organization and operation of pharmaceutical units approved by OMS no. 444/2019.
-The document is downloaded, filled in, and then uploaded to the platform, signed with an extended electronic signature.
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The procedure addresses pharmaceutical units in Romania for the establishment of LOCAL DISTRIBUTION OFFICES - submission of documents to the Public Health Directorate.
*The procedure is addressed to the establishment of closed-circuit pharmacies serving healthcare units and/or outpatient clinics. The manager of the healthcare unit submits the application accompanied by the requested documentation. The applicant must upload on the platform the documents stipulated in Ord MS 444/2019 - submission of documents to DSP, preparation by the local DSP of the verification report and the compliance or non-compliance decision, and uploading them on the platform.
*The procedure is addressed to drugstores for the establishment of a chief drugstore unit - chief pharmacist or chief pharmacy assistant. The Ministry of Health, Directorate for Medicine Policy and Medical Devices is also notified simultaneously.
*The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that were the basis for issuing the operating authorization - relocation of headquarters/branch. 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.
*The procedure is addressed to pharmaceutical units in situations where there are changes to the conditions that formed the basis of the operating authorization - any other modification made to the premises of the pharmaceutical unit, except for the relocation of the headquarters/branch. Changes must be reported to the Ministry of Health - Directorate for Medicine Policy and Medical Devices within 5 working days from the date of the change.
*The procedure is addressed to pharmaceutical units in situations where the request is made to register the mention of resumption of activity during the suspension interval 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 sent 60 working days before the expiration of the legal suspension period.
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