Ministry of Health Pharmaceutical and Medical Devices Directorate*
Available procedures
Procedure regarding the establishment of prices for human-use medicines in Romania*
Procedure regarding the establishment of prices for human use medicines in Romania that have the status of: orphan, immunological, medicines derived from blood and human plasma, medicines notified regarding discontinuity.*
CORRECTION drug prices COST VOLUME (art.24-OMS no.368/2017)*
The procedure is addressed to holders of marketing authorization (DAPP) or their legal representatives.
It refers exclusively to products that are subject to cost-volume or cost-volume-result contracts and which fall under the incidence of art. 24 para. (4), (5), and (6) of the Order of the Minister of Health no. 368/2017, with subsequent amendments and additions.
- art. 24 " (4) In the situation where, within the interval mentioned in para. (2), the negotiation process is resumed for a medication for which there are no longer eligible patients subject to the clauses of the cost-volume or cost-volume-result 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 additions, the annual correction procedure provided for in para. (5) and (6) shall apply.
(5) In the situation where the medications 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 execution of cost-volume/cost-volume-result contracts, the MAH holder/representative shall submit the documentation for the correction at least 90 days before the expiration of the contractual period. At least 45 days before the expiration of the price validity in Canamed, the Ministry of Health communicates to the National Health Insurance House (CNAS) and the MAH holder the internal price approval for the resumption of the negotiation process.
(6) The maximum price levels provided for in para. (5) are included in Canamed and enter into force starting from the 1st of the month following the end of the validity of the existing prices in Canamed."
- art. 24 para. (2)" In the situation where the medications 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 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 cessation of the validity 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 additions. "
This procedure can be accessed by following the link below and then pressing the button "for 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 on the basis of the PARALLEL IMPORT AUTHORIZATION or on the basis of the PARALLEL DISTRIBUTION AUTHORIZATION (THE ORIGINAL MEDICINE DIRECTLY DISTRIBUTED HAS THE APPROVED PRICES IN CANAMED)*
Approval of prices for medicines that have changed/maintained the CIM/DAPP/trade name code*
Procedure for approving the prices of medicines for which MAH requests a voluntary reduction of the manufacturer price*
Procedure for approving 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.
Approval procedure for medicine prices in the case of extending the validity of the authorisation for the supply of medicines for special needs*
Procedure regarding the establishment of prices for medicines needed for PUBLIC HEALTH REASONS*
The procedure addresses marketing authorization holders (MAH) or their legal representatives who request the approval of prices for medicinal products authorized under Order of the Minister of Health no. 1540/2021 for the approval of the Rules for the application of the provisions of art. 883 of Law no. 95/2006 regarding health sector reform concerning the authorization of placing on the market certain medicinal products required for public health reasons.
*Approval for the destruction of plants, substances, and narcotic and psychotropic preparations*
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.
- 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