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Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include relocation of headquarters/work point (UF-DSP)*
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Procedure
Online
Companii
Cetateni
Institutii
National
ROEID
Details
The procedure addresses pharmaceutical units in situations where changes occur in the conditions that formed the basis for issuing the operating authorization - any other change made to the space of the pharmaceutical unit, except for relocating the headquarters/place of business. The changes must be notified to the Ministry of Health - Directorate of Medicines Policy and Medical Devices within 5 working days from the date of the change.
*Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
The operating authorization or the duplicate issued by the Ministry of Health in case of loss of the authorization*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
The document certifying the right of use over the space designated as a pharmaceutical unit*
Descarcă
- is uploaded to the platform, signed with an advanced electronic signature*
The outline of the space prior to the changes made*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The sketch of the space after the modifications have been made*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Technical memorandum*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
Proof of payment of the fee provided by law*
Descarcă
art. 42 - Law no. 266/2008 - The Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
Proof of having sent to the College of Pharmacists of Romania, the territorial branch corresponding to the county in which the pharmaceutical unit operates, the notification according to model no. 9 from the annex to Regulations*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Request type applicant*
Descarcă
According to Model no. 3 from the annex to the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. The request is addressed to the Ministry of Health and will be communicated to it by the DSP. - The document is downloaded, completed, and then uploaded to the platform, signed with an extended electronic signature.*
Request template to the DSP*
Descarcă
According to Model no. 2 from the annex to the Norms regarding the establishment, organization, and operation of pharmaceutical units approved by OMS no. 444/2019. - The document is downloaded, completed, and then uploaded to the platform, signed with an extended electronic signature.*
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
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*
- 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
266
dated year
2009
LAW no. 266 of November 7th, 2008 of the pharmacy ISSUER: PARLIAMENT PUBLISHED IN: OFFICIAL GAZETTE no. 765 of November 13th, 2008*
- 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*
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
Table of contents
Competent entities
Compartiment Farmaceutic
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