Ministry of Health Directorate of Pharmaceuticals and Medical Devices*
Available procedures
Procedure regarding the setting of prices for human use medicines in Romania*
Procedure regarding the setting of prices for human-use medicines in Romania that have the status of: orphan, immunological, blood and human plasma-derived medicines, medicines notified regarding discontinuation.*
CORRECTION of drug prices COST VOLUME (art.24-OMS no.368/2017)*
The procedure is addressed to holders of marketing authorization (MAH) or their legal representatives.
It refers exclusively to products that are subject to cost-volume or cost-volume-outcome contracts and which fall under art. 24 para. (4), (5), and (6) of the Order of the Minister of Health no. 368/2017, with subsequent amendments and completions.
- art. 24 " (4) In the situation where, during the interval mentioned in para. (2), the negotiation process is resumed for a medicine for which there are no longer eligible patients subject to the clauses of the cost-volume or cost-volume-outcome contract/contracts 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 in paragraphs (5) and (6) applies.
(5) In the situation where the medicines provided in paragraph (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 the implementation and conduct of cost-volume/cost-volume-outcome contracts, the holder of the MAH/representative will submit the documentation for correction at least 90 days before the expiry of the contractual period. 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 notice for the resumption of the negotiation process.
(6) The maximum price levels provided in paragraph (5) are included in Canamed and come into force starting on the 1st of the month following the expiry of the existing prices in Canamed."
- art. 24 para. (2)" In the situation where the medicines provided in paragraph (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 of the validity of the last cost-volume or cost-volume-outcome 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
*Procedure regarding the establishment of prices for medicines marketed based on the PARALLEL IMPORT AUTHORIZATION or based on the PARALLEL DISTRIBUTION AUTHORIZATION (THE ORIGINAL MEDICINE DISTRIBUTED DIRECTLY HAS PRICES APPROVED IN CANAMED)*
Approval of prices for medicines that have changed/maintained their CIM/DAPP code/trade name*
Procedure for approving medicine prices for which MAH requests voluntary reduction of the manufacturer price*
Procedure for the approval of prices for medicines authorized for the supply of medicines for special needs (ANS)*
The procedure is addressed to holders of authorization for the supply of medicines for special needs or their legal representatives.
Procedure for approving medicine prices in case of extending the validity of the authorization for the supply of medicines for special needs*
Procedure regarding the establishment of prices for medicines needed for PUBLIC HEALTH REASONS*
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.
*Aprobarea de distrugere a plantelor, substanţelor şi preparatelor stupefiante şi psihotrope
Destruction of substances and preparations identified as qualitatively inappropriate 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, is 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.
Legislation governing the method of 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 in the PCUe platform:
- Standard application; this must be filled out and electronically signed by both the legal representative of the company and the chief pharmacist/person responsible for activity with narcotics and psychotropics;
- List with the names and quantities of plants, substances and narcotic and psychotropic preparations to be destroyed; this 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 activity 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 PDF or JPEG format; the file must 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 of the destruction approval issuance fee (100 lei); the document must be submitted in PDF format, with the legal representative's electronic signature.
- Approval can be issued directly to the applicant's delegate who signs for receipt on one of the copies, or:
- Approval can be issued by mail to the applicant's address in accordance with the Ministry of Health's procedure.
Important information regarding payment of the issuance fee:
- Bank account: RO96TREZ70020160103XXXXX
- Treasury: A.T.C.P. Mun. București (Treasury and Public Accounting Activity of Bucharest Municipality)
- C.I.F. (tax identification code): 4266456