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Modification of initial authorization conditions - ANY CHANGE TO THE SPACE - Does not include moving the headquarters/work point (UF-DSP)*
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Procedure
Online
Companii
Cetateni
Institutii
National
ROEID
Details
The procedure is addressed to pharmaceutical units in situations where changes occur in the conditions that were the basis for issuing the operating authorization - any other modification made to the pharmaceutical unit's premises, except for the relocation of the headquarters/branch. The changes must be notified to the Ministry of Health - Directorate for Medicinal 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 for the space designated as a pharmaceutical unit*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The outline of the space before the changes made*
Descarcă
- is uploaded to the platform, signed with an extended electronic signature*
The outline of the space after 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 required by law*
Descarcă
art. 42 - Law no. 266/2008 - Pharmacy Law, republished - is uploaded to the platform, signed with an extended electronic signature*
Proof of submission to the College of Pharmacists of Romania, the territorial branch corresponding to the county where the pharmaceutical unit carries out its activity, of the notification according to model no. 9 from the annex to the Norms*
Descarcă
- it is uploaded to the platform, signed with an extended electronic signature*
Applicant type request*
Descarcă
According to Model no. 3 from the annex to the Norms regarding the establishment, organization and functioning 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.*
Standard request to the Public Health Directorate*
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, filled in, 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:
5
Calendar days
Appeal routes
In the case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
30 June 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.
Vaslui 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.
Str.Republicii, nr.367, sc. E & F
Telefon:
0235312455
Fax:
0235/317351
Email:
secretariat@dspvs.ro
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