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Authorization of community pharmacies for SEASONAL FLU VACCINATION ACTIVITY (UF-MS)*

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Procedure
Online
Companii
National

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.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


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Standard request - annex no. 2 from OMS no. 3262/2022*
Descarcă
Formular tipizat
The request is provided in the Order of the Minister of Health no. 3262/2022 for the approval of the organization and functioning of a pilot program for vaccinating the population against seasonal flu at the level of community pharmacies, published in the Official Gazette of Romania no. 1031 and no. 1031 bis from October 24, 2022. - The document is downloaded, completed, and then uploaded to the platform, signed with an extended electronic signature IMPORTANT!!! The uploaded request must be named obligatorily in the form "pharmacy name_county initials" e.g.: ANAFARM_MB1.pdf (MB1 = Bucharest municipality, district 1), MARIAFARM_BV.pdf*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The operating permit or the duplicate issued by the Ministry of Health in case of loss of the permit, with all mentions and annexes*
Descarcă
Scanned document
- The document is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Technical memorandum assumed by the representative of the legal entity that owns the pharmacy*
Descarcă
Scanned document
The technical memorandum will obligatorily contain the sketch of the pharmacy space, highlighting the space specially designated for vaccination, post-vaccination monitoring, and a description of the equipment and organization of this space - The document is uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The list of pharmacists who will carry out vaccination activities against seasonal flu*
Descarcă
Scanned document
- The document is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Certificates of completion of the training program in vaccination against seasonal flu for pharmacists designated for the activity of vaccination against seasonal flu*
Descarcă
Scanned document
- The document is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The contract concluded with an authorized economic operator for the transport, treatment, and disposal of medical waste*
Descarcă
Scanned document
- The document is uploaded to the platform, signed with an advanced electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of notification of the territorial colleges of pharmacists in Romania, as well as the municipality of Bucharest, regarding the intention to authorize the pharmacy*
Descarcă
Scanned document
- The document is uploaded to the platform, signed with an extended electronic signature*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Declaration on own responsibility regarding compliance with the provisions of art. 4 of OMS no. 3262/2022*
Descarcă
Scanned document
Art. 4 of OMS no. 3262/2022 - In order to be authorized to participate in the population vaccination program against seasonal influenza, the community pharmacy must meet the following conditions: a) to possess a valid operating authorization issued by the Ministry of Health; b) to have the technical memorandum assumed by the representative of the legal entity that owns the pharmacy, which will obligatorily include the sketch of the pharmacy premises, highlighting the special area designated for vaccination and the description of the equipment and organization of this area; c) to have a space dedicated to vaccination activities meant to ensure the safety and confidentiality of the vaccination process; d) the space where vaccination is carried out must be equipped with a table or a desk covered with washable materials that are easy to clean and disinfect, chairs or a couch for vaccination, dispensers with antiseptic substances, a first aid kit in case of anaphylactic shock, as well as special containers for the collection and temporary storage of hazardous waste resulting from medical activity, according to the legislation in force; elimination of hazardous waste shall be done in accordance with the legislation in force; e) the existence of a refrigerator equipped with a calibrated thermometer for storing and maintaining the vaccines under optimal and monitored temperature conditions, sufficient quantities of protective materials and equipment, namely gloves, gowns, antiseptic substances, as well as a computer with an internet connection for registering the vaccinations carried out in the National Electronic Vaccination Registry (RENV); f) to ensure the observance of the cold chain, the reception and transport of the vaccines, as well as the storage and administration of these in conditions of maximum safety; g) to ensure adherence to vaccine storage procedures, continuous monitoring of storage temperature, identification of cold chain events and their reporting; h) to possess the list of pharmacists who have obtained the certificate of completion of the training program for vaccination activity against seasonal influenza; i) to possess the contract concluded with an authorized economic operator for the transport, treatment and disposal of medical waste. - The document is uploaded to the platform, signed with an extended electronic signature.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents

Denumire

Tip document

Descarcă


-
Annex (mentions) to the Authorization for the operation of the community pharmacy*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Fees

Title

Payment method

Value

Currency


None
Deadlines
Resolution time:
5
Calendar days
Case filling duration:
5
Calendar days
Notification deadline:
2
Calendar days
Legislation
None
Appeal routes

In the event of a dispute between the beneficiary and the competent authority, the provisions of common law apply.

*
Additional information
More info:
Links
Assistance and problem-solving services
None
Last updated: 
09 February 2023
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Institution responsible with document: 
Publicat de către: 
A paragraph is a self-contained unit of a discourse in writing dealing with a particular point or idea. Paragraphs are usually an expected part of formal writing, used to organize longer prose.
Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
*Content marked with an asterisk (*) has been automatically translated and may not fully reflect the original meaning. For objective interpretation, please consult the Romanian version.
Ministry of Health Pharmaceutical Units Authorization and Monitoring Department*
Intr. Cristian Popisteanu, nr. 1-3
Telefon: 0213072500
Fax:
Email: relatii.publice@ms.ro
Table of contents

Competent entities

Compartimentul Autorizare și Monitorizare Unități Farmaceutice

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