Approval and Registration of Manufacturer Prices for Medicines

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  Step 1. Submission of the Request

  In order to approve the manufacturer prices for medicines, in accordance with the provisions of the Regulation on the Approval and Registration procedure of the Manufacturer Prices for Medicines, approved by Government Decision No. 295/2023, the applicant submits the following documents to the Single Counter within the Medicines and Medical Devices Agency:

  1. The application and the set of documents regarding the approval and registration of the manufacturer price for medicines, submitted 60 days before the expiration date of the approved price;
  2. The set of documents, on paper/electronic format, submitted to the Single Counter of the Agency contains:

  • the standard application form signed by the applicant, which contains the declared price;
  • the self-declaration signed by the applicant;
  • the information comparing the proposed price with the authorized manufacturer price from the reference countries, including copies of the Manufacturer Price Catalog of the presented countries, valid on the date of the application submission. In the absence of these, must be provided a copy of the Manufacturer Price Catalog of the country of origin, translated (with the signature and stamp of the translation office) into Romanian, English, or Russian;
  • the notarized power of attorney in Romanian, English, or Russian presented by the applicant from the manufacturer`s central office of, empowered to register the manufacturer price.

  

  

• 2
  Step 2. Examination of the set of documents

  The Prices Department is responsible for the reception and validation of the document sets (files) submitted for the registration of manufacturer prices for medicinal products.

  If the document set is incomplete or it requires corrections to the proposed price, the Agency notifies the applicant up to 30 working days from the date of submission.

• 3
  Step 3. Specialized Examination

  The Prices Department completes and approves the evaluation form i with the requested data and reference prices according to the GD No. 295/2023. A summary of the evaluation data is prepared based on the approved evaluation forms.

  
  

  The next steps are:

  • Evaluation by the Committee for the Approval of Manufacturer Prices for Medicines;
  • Preparation of notifications based on the decision of the Committee for the Approval of Manufacturer Prices for Medicines and, if it is applicable, informing applicants about the negotiations;
  • Evaluation by the Negotiation Committee regarding the approval of manufacturer prices for medicines;
  • Notification of the decision of the Negotiation Committee regarding the approval of manufacturer prices for medicines;
  • Re-evaluation of the manufacturer prices for generic medicines following the approval of original medicine prices;

• 4
  Step 4. Approval of the Order "Regarding the Registration of Manufacturer Prices for Medicines" and/or the Order "Regarding the Registration of Manufacturer Prices for Medicines through Negotiation"

  Drafting the order "Regarding the Registration of Manufacturer Prices for Medicines" and/or the draft order "Regarding the Registration of Manufacturer Prices for Medicines through Negotiation", followed by generating the documents from the SIAC AMDM system for approval by the General Director of MMDA.

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  Step 5. Updating the National Manufacturer Prices Catalogue for Medicines

  Updating the National Manufacturer Prices Catalogue for Medicines with the information from the approved orders and generating it from the SIAC AMDM system. The National Manufacturer Prices Catalogue for Medicines is published on the official website of MMDA.