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Approval for the destruction of plants, substances, and narcotic and psychotropic preparations*
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Procedure
Online
Companii
National
The procedure provides the method for obtaining approval for the destruction of plants, substances, and narcotic and psychotropic preparations, in accordance with art. 48 of Law 339/2005 and art. 51-54 of Government Decision 1915/2006.
The destruction of substances and preparations identified as qualitatively inadequate by the authorized legal entity or by the National Agency for Medicines, as the case may be, with expired validity or which have been returned, shall be carried out by an authorized company, based on the destruction approval issued by the Ministry of Health and in the presence of a commission constituted under the conditions provided in the methodological norms for the application of Law 339/2005.
The legislation regulating the method for destruction of plants, substances, and narcotic and psychotropic preparations can be consulted in the "Normative Acts" section.
To obtain approval for the destruction of narcotic and psychotropic plants/substances/preparations, the following documents must be submitted on the PCUe platform:
The destruction of substances and preparations identified as qualitatively inadequate by the authorized legal entity or by the National Agency for Medicines, as the case may be, with expired validity or which have been returned, shall be carried out by an authorized company, based on the destruction approval issued by the Ministry of Health and in the presence of a commission constituted under the conditions provided in the methodological norms for the application of Law 339/2005.
The legislation regulating the method for destruction of plants, substances, and narcotic and psychotropic preparations can be consulted in the "Normative Acts" section.
To obtain approval for the destruction of narcotic and psychotropic plants/substances/preparations, the following documents must be submitted on the PCUe platform:
- Standard application form; it must be completed and signed electronically by both the legal representative of the company and the chief pharmacist/person responsible for activities with narcotics and psychotropics;
- List with names and quantities of the narcotic and psychotropic plants, substances, and preparations to be destroyed; the list must be drafted and uploaded to the platform in excel format;
- The list from point 2, completed and scanned in PDF format, electronically signed by the chief pharmacist/person responsible for activities with narcotics and psychotropics;
- Copy of the contract concluded with the authorized company for the destruction operation; it can be uploaded to the platform in scanned format, PDF or JPEG; the file will be electronically signed by the legal representative;
- Copy of the authorization for activity with narcotic and psychotropic plants, substances, and preparations. Upload in PDF format.;
- Proof of payment for the destruction approval issuance fee (100 lei); the document will be presented in PDF format, with the legal representative’s electronic signature.
All fields in the application are mandatory; failure to complete them will result in rejection of the application. If the necessary information to complete a field is not available, fill it with a horizontal line.
The approval will be issued in physical format. After issuance, the approval will be handed over to the applicant as follows:
- Approval issuance can be done directly to the applicant’s delegate who signs for receipt on one of the copies, or:
- Approval issuance can be done by mail to the applicant’s address according to the Ministry of Health procedure.
Important information regarding the fee payment for issuance:
- Bank account: RO96TREZ70020160103XXXXX
- Treasury: A.T.C.P. Mun. Bucharest (Treasury and Public Accounting Activity of the Municipality of Bucharest)
- C.I.F. (tax identification code): 4266456
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
1. Request for the issuance of approval for the destruction of plants, substances, and narcotic and psychotropic preparations*
Descarcă
Formular tipizat
The standard application form, completed and electronically signed by both the legal representative of the company and the chief pharmacist/person responsible for activities involving narcotics and psychotropics.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
2. List of plants, substances, and preparations to be destroyed (Excel)*
Descarcă
Formular tipizat
The list is completed in Excel format, following the attached model. Adding new columns is not permitted. For relevant information other than that included in the predefined columns, the "Observations" column will be used.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
3. List of plants, substances, and preparations to be destroyed (PDF)*
Descarcă
Scanned document
The same list as in point 2, completed, scanned or exported in PDF format and signed by the chief pharmacist/responsible person.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
4. Copy of the contract concluded with the authorized company for the destruction operation*
Descarcă
Scanned document
The copy of the contract, scanned in PDF format and electronically signed by the legal representative.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
5. Copy of the authorization for activities involving plants, substances and narcotic and psychotropic preparations*
Descarcă
Scanned document
Copy of the authorization for activity with plants, substances and narcotic and psychotropic preparations, scanned, in PDF format.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Proof of payment for issuing the approval fee*
Descarcă
Scanned document
Proof of payment of the fee in PDF format (scanned or exported from the payment system)*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents
Denumire
Tip document
Descarcă
-
Fees
Title
Payment method
Value
Currency
Taxă fixă
OP
100.0
Taxă fixă
GHISEUL
100.0
Deadlines
Resolution time:
60
Calendar days
Case filling duration:
30
Calendar days
Notification deadline:
5
Calendar days
Legislation
Appeal routes
In the event of a dispute between the beneficiary and the competent authority, the common law provisions are applicable.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
22 October 2024
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 and Medical Devices 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.
Ministry of Health Pharmaceutical and Medical Devices Directorate*
Str. Cristian Popisteanu, nr.1-3, Sector 1
Telefon:
0213072500
Fax:
Email:
relatii.publice@ms.ro
Table of contents
Competent entities
Compartiment Reglementare în Domeniul Psihotropelor si Stupefiante
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