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Resumption of activity during the suspension period of the operating authorization or upon expiry of the period - WITH CHANGE OF HEADQUARTERS/WORKING POINT ADDRESS (UF-DSP)*

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Procedure
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Companii
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Details

The procedure is addressed to pharmaceutical units in situations where the registration of the mention of resumption of activity is requested during the suspension period or upon its expiration. The resumption of activity takes place at a different address of the headquarters/branch than the initial one. Documents must be submitted 60 working days before the legal suspension period expires.

*
Entitled persons
Regulated professions
Required documents

Denumire

Descriere

Obligatoriu

Semnătură digitală

Tip document

Descarcă


-
DSP type request*
Descarcă
Formular tipizat
obligatoriu cu semnatură digitală disponibil și prin OOTS
According to Model no. 2 annex from the Norms regarding the establishment, organization, and functioning of pharmaceutical units approved by OMS no. 444/2019. - Download the document, fill it in, and then upload it to the platform, signed with an extended electronic signature.*
The operating permit or duplicate issued by the Ministry of Health in case of loss of the permit*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- it is uploaded to the platform, signed with an extended electronic signature*
Updated certificate of attestation with the new address of the work point*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an advanced electronic signature*
The document attesting the right of use over the space designated for a pharmaceutical unit*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an advanced electronic signature*
Space sketch*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
The technical memorandum regarding the new space of the pharmaceutical unit*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an extended electronic signature*
Certificate regarding the demographic criterion*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- According to art. 20 of Law no. 266/2008 - the Pharmacy Law, republished - In the situation where the address of the pharmaceutical unit is in the same locality, a declaration proving this fact must be uploaded - it is uploaded on the platform, signed with an extended electronic signature*
Proof of transmission to the College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit operates, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
- is uploaded to the platform, signed with an advanced electronic signature*
Proof of payment of the fee provided by law*
Descarcă
Scanned document
obligatoriu cu semnatură digitală disponibil și prin OOTS
art. 42 - Law no. 266/2008 - The Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
Request type applicant*
Descarcă
Formular tipizat
obligatoriu cu semnatură digitală disponibil și prin OOTS
According to model no.3 from the annex to the Regulations regarding the establishment, organization and operation of pharmaceutical units approved by OMS NR 444/2019. The request is addressed to the Ministry of Health and will be communicated to it by the DSP. -The document is downloaded, filled out, and then uploaded to the platform signed with an extended electronic signature.*
Issued documents

Denumire

Tip document

Descarcă


-
Compliance decision of the space designated as a pharmaceutical unit*
obligatoriu cu semnatură digitală disponibil și prin OOTS
Inspection report*
obligatoriu cu semnatură digitală disponibil și prin OOTS
Fees

Title

Payment method

Value

Currency


None
Deadlines
Resolution time:
40
Calendar days
Case filling duration:
20
Calendar days
Notification deadline:
Calendar days
Legislation
- Law number 
444
 dated year 
2019
ORDER No. 444 of March 25, 2019 for the approval of the Rules regarding the establishment, organization, and operation of pharmaceutical units ISSUED BY Ministry of Health PUBLISHED IN Official Gazette No. 270 of April 9, 2019*
- Law number 
266
 dated year 
2009
LAW no. 266 of November 7, 2008 of the pharmacy ISSUER: PARLIAMENT PUBLISHED IN: OFFICIAL GAZETTE no. 765 of November 13, 2008*
- Law number 
75
 dated year 
2010
ORDER no. 75 of February 3, 2010 for the approval of the Rules of Good Pharmaceutical Practice ISSUED BY: MINISTRY OF HEALTH PUBLISHED IN: OFFICIAL GAZETTE no. 91 of February 10, 2010*
- Law number 
484
 dated year 
2025
ORDER no. 484 of February 11, 2025 regarding the amendment and completion of the Order of the Minister of Health no. 444/2019 for the approval of the Rules regarding the establishment, organization and functioning of pharmaceutical units ISSUED BY Ministry of Health PUBLISHED IN Official Gazette no. 167 of February 25, 2025*
Appeal routes

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

*
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated: 
06 July 2026
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.
Teleorman Public Health Directorate*
*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.
Av.Alexandru Colfescu nr. 79, Alexandria, RO
Telefon:
Fax: 0247 312 224
Email: aaii@dsptr.ro
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Compartiment Farmaceutic
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