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products & fees 2013

The list of product types gives an overview of the product types used at the MEB. The assigned product type determines the workflow.
You will receive a confirmation with details about the product type of your application.

NEW APPLICATIONS


New active substance (package fee)

National application

 €43,900.-

Surcharge for MRP with NL=RMS

 €19,570.-
  • Application via DCP with NL=RMS
 €63,470.-
  • Application via MRP with NL=CMS
 €19,780.-
  • Application via DCP with NL=CMS
 €31,735.-
Known active substance (generic application) (package fee)
  • National application
 €23,060.-
    Surcharge for MRP with NL=RMS €13,810.-
  • Application via DCP with NL=RMS
 €36,870.-
  • Copy - application via DCP with NL=RMS

    If a copy-dossier is added at the start (submitted concurrently) or during the procedure, a copy fee (= €15,800) applies for this dossier.

    If a copy is submitted after conclusion of the original procedure and thus a new procedure has to be followed, a normal fee (= € 36,870) will be charged.

 €15,800.-
  • Application via MRP with NL=CMS
   €7,700.-
  • Application via DCP with NL=CMS
 €18,435.-

Line extensions (package fee)
A line extension is an application for a product that only differs in pharmaceutical form and/or strength from one or more other pharmaceutical products for which the applicant either holds a marketing authorisation, or has submitted a marketing authorisation application.

  • National application
 €14,980.-

    Surcharge for MRP with NL=RMS

 €13,810.-
  • Application via DCP with NL=RMS
 €28,790.-
  • Application via MRP with NL=CMS
   €3,660.-
  • Application via DCP with NL=CMS
 €14,395.-

Duplex marketing authorisations (package fee)
A duplex marketing authorisation is a marketing authorisation for a product of which the dossier is identical to that of a product that is already registered.

  • Known active substance
   €5,800.-

    

Parallel import and replica marketing authorisations
  • Per product (no package fee)
   €1,465.-

Variations
As from 1-1-2010 all variations are included in the annual fee 

Scientific advice

Band 1 – Simple advice

  • Regulatory advice
  • Advice regarding pharmaceutical or pre-clinical aspects of the medicinal product
  • Follow-up advice
  • Written advice

€3,500.-

Band 2 – Partly multidisciplinary scientific research

  • Pure clinical advice regarding the efficacy and safety of a medicinal product with or without pharmaceutical or pre-clinical advice
  • Combination of pharmaceutical and pre-clinical advice
 € 6,000

Band 3 – Complete multidisciplinary advice

 € 8,000

Consultation procedure for medical devices
  • new use of a medicinal product in a medical device
 €12,000.-
  • known use of a medicinal product in a medical device
   €3,600.-
  • change in use of a medicinal product in a medical device
   €1,200.-

Homeopathic pharmaceutical products
The amounts stated below are package fees for all strengths of a product line containing the same homeopathic ingredient(s).

New applications
  • products with an indication or intended for other than oral or external use
   €2,400.-
  • products with no indication and intended for oral or external use
   €1,200.-

    surcharge for MRP with NL=RMS

   €2,800.-

Variations

      €600.-

Traditional herbal medicinal products
  • National application
   €2,600.-

    surcharge for MRP with NL=RMS

   €2,800.-

Variations

      €600.-

Annual fee
The annual fee for allopathic pharmaceutical products is €1050.-. This amount is charged for each registered product (i.e. RVG number).
All variations are included in the annual fee.

Homeopathic pharmaceutical products
For homeopathic pharmaceutical products, the annual fee is €30.-. In principle, this sum is charged for each registered product (i.e. RVH number), but is charged only once for all strengths of a product range containing the same ingredient(s) from a single marketing authorisation holder. For traditional herbal medicinal products the annual fee is €490.-.
   
Payment of fees  
Fees for new applications and variations   
The Regulation concerning the registration of medicinal products states that evidence of payment must accompany a marketing authorisation or variation application. However, for practical reasons this requirement is currently not enforced. An invoice is sent once an application has been accepted for assessment. If the amount due has not been deposited in our bank account within 30 days, assessment of the application will be suspended and a reminder will be issued. The assessment procedure will be recommenced following receipt of payment.
   
Annual fees   
The reference date for calculation of the fees is 1st January of each year. If the annual fees have not been paid within 30 days of receipt of the invoice, a reminder will be issued. If no payment is received within the following 30 days, the marketing authorisations for the products concerned may be revoked.

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