Ministry of Health Directorate of Pharmaceuticals and Medical Devices*

The procedure is addressed to marketing authorization holders (MAHs) or their legal representatives.

It refers exclusively to products that are the subject of cost-volume or cost-volume-result contracts and which fall under Article 24, paragraphs (4), (5), and (6) of the Order of the Minister of Health no. 368/2017, with subsequent amendments and completions.

- art. 24 " (4) In situations where, during the period mentioned in para. (2), the negotiation process is resumed for a medicine for which there are no more eligible patients subject to the clauses of the cost-volume or cost-volume-result contract(s) concluded based on the Order of the Minister of Health and the President of the National Health Insurance House no. 3/1/2015, with subsequent amendments and completions, the annual correction procedure provided for in para. (5) and (6) shall apply.

(5) In situations where the medicines provided for in para. (1) are subject to the provisions of the Order of the Minister of Health and the President of the National Health Insurance House no. 735/976/2018 regarding the contract model, negotiation methodology, conclusion and monitoring of the implementation and running of cost-volume/cost-volume-result contracts, the MAH/representative shall submit the documentation for correction at least 90 days before the contractual term expires. At least 45 days before the expiry of the price validity in Canamed, the Ministry of Health communicates to the National Health Insurance House (CNAS) and the MAH the internal price approval for resuming the negotiation process.

(6) The maximum price levels provided for in para. (5) are included in Canamed and come into effect starting with the 1st of the month following the cessation of the validity of the existing prices in Canamed."

- art. 24 para. (2)" Where the medicines provided for in para. (1) are subject both to the provisions of the Order of the Minister of Health and the President of the National Health Insurance House no. 3/1/2015 (...), and to the provisions of the Order of the Minister of Health and the President of the National Health Insurance House no. 735/976/2018 (...), the annual correction procedure does not apply for 12 months from the termination date of the last cost-volume or cost-volume-result contract concluded based on the Order of the Minister of Health and the President of the National Health Insurance House no. 3/1/2015, with subsequent amendments and completions. "

This procedure can be accessed by following the link below and then pressing the button "for the online service apply here":

http://www.ms.ro/organizare/directia-politica-medicamentului-si-a-dispozitivelor-medicale/#tab-id-7

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The procedure is addressed to holders of authorization for the supply of medicines for special needs or their legal representatives.

​The procedure is addressed to holders of marketing authorization (DAPP) or their legal representatives who request the approval of the prices of medicines authorized on the basis of Order of the Minister of Health no. 1540/2021 for the approval of the Application Norms of the provisions of art. 883 of Law no. 95/2006 regarding the reform in the field of health concerning the authorization of the marketing of certain medicines required for public health reasons.

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:

1. 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;
2. 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;
3. The list from point 2, completed and scanned in PDF format, electronically signed by the chief pharmacist/person responsible for narcotic and psychotropic activity;
4. 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;
5. Copy of the authorization for activity with narcotic and psychotropic plants, substances and preparations. Must be uploaded in PDF format;
6. 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:

1. The approval may be issued directly to the applicant’s delegate who signs for receipt on one of the copies, or:
2. 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:

1. Bank account: RO96TREZ70020160103XXXXX
2. Treasury: A.T.C.P. Mun. București (Treasury and Public Accounting Activity of Bucharest Municipality)
3. C.I.F. (fiscal identification code): 4266456