Aprobarea de distrugere a plantelor, substanţelor şi preparatelor stupefiante şi psihotrope
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The procedure provides the method for obtaining approval for the destruction of narcotic and psychotropic plants, substances and preparations, in accordance with art. 48 of Law 339/2005 and art. 51-54 of GD 1915/2006.
The destruction of substances and preparations identified as not compliant in terms of quality by the authorized legal entity or by the National Agency for Medicines, as the case may be, with expired validity period or that have been returned, is performed by an authorized company, based on the destruction approval issued by the Ministry of Health and in the presence of a commission established under the conditions stipulated in the methodological norms for the application of Law 339/2005.
The legislation regulating the means of destruction for narcotic and psychotropic plants, substances and preparations can be consulted in the Normative Acts section.
For obtaining the destruction approval for narcotic and psychotropic plants/substances/preparations, the following documents need to be submitted on the ROePAS platform:
- Standard request; it must be completed and electronically signed by both the company’s legal representative and the chief pharmacist/person responsible for narcotic and psychotropic activity;
- List with the names and quantities of 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 narcotic and psychotropic activity;
- Copy of the contract concluded with the company authorized for the destruction operation; this can be uploaded to the platform as a scanned PDF or JPEG; the file must be electronically signed by the legal representative;
- Copy of the authorization for activity with narcotic and psychotropic plants, substances and preparations. Must be uploaded in PDF format;
- Proof of payment for the destruction approval issuance fee (100 lei); the document must be presented in PDF format, with the electronic signature of the legal representative.
All fields within the application form are mandatory; failure to complete them will result in the rejection of the application. Where the necessary information does not exist to fill in a field, a horizontal line should be entered.
The approval will be issued in physical format. After the approval is issued, it will come into the possession of the applicant as follows:
- The approval may be issued directly to the applicant’s delegate who signs for receipt on one of the copies, or:
- The approval may be issued by mail to the applicant’s address according to the Ministry of Health procedure.
Important information regarding the issuance fee payment:
- Bank account: RO96TREZ70020160103XXXXX
- Treasury: A.T.C.P. Mun. București (Treasury and Public Accounting Activity of Bucharest Municipality)
- C.I.F. (fiscal identification code): 4266456
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In the event of a dispute between the beneficiary and the competent authority, the common law provisions shall apply.
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