Fees and product types

New applications

	Fee (euro)
National application new active substance
Application via the National procedure	61,680
Application via MRP with NL=RMS	27,490
Application via DCP with NL=RMS	89,170
Application via MRP with NL=CMS	27,790
Application via DCP with NL=CMS	44,090
Application with existing active substance
Application via the National procedure	32,400
Application via MRP with NL=RMS	19,410
Application via MRP with NL=RMS repeat use	6,180
Application via MRP with NL=RMS repeat use Zero day	630
Application via DCP with NL=RMS	51,810
Copy application via DCP with NL=RMS	22,210
Application via MRP with NL=CMS; incl. NL=CMS repeat use	10,800
Application via DCP with NL=CMS	25,900
Line extensions
Application via the National procedure	21,030
Application via MRP with NL=RMS	19,410
Application via DCP with NL=RMS	40,440
Application via MRP NL=CMS	5,150
Application via DCP with NL=CMS	20,230
Duplex authorisations
National application known active substance	8,150
Informed consent
National application known active substance	8,150
Application for parallel marketing authorisation
Per application for a parallel marketing authorisation	2,260

Variations

All variations - with the exception of the variations listed in article 7.2, first paragraph, heading and sub-section d and second paragraph, heading and sub-section d, article 7.3, heading and sub-section d and article 7.4, heading and sub-section c of the Medicine Law Regulation, are included in the annual fee as of January 2010.

Scientific advice

Fee rate 1 (euro) - Simple advice	7,300
Regulatory advice
Advice regarding the pharmaceutical or pre-clinical aspects of the medicinal product
Follow-up advice
Fee rate 2 (euro) - Partial multi-disciplinary scientific advice	12,480
Purely clinical advice relating to safety and efficacy of a medicinal product, separately or in combination with pharmaceutical or pre-clinical advice
Combination of pharmaceutical and pre-clinical advice
Fee rate 3 (euro) - Complete multi-disciplinary advice	16,650
Advice regarding the clinical, pre-clinical and pharmaceutical aspects of the medicinal product
Fee rate 4 (euro) - Customised advice	2,460
Scientific advice mainly for small companies, generally related to the pharmaceutical or pre-clinical aspects of a medicinal product in the early phase of development

Consultation procedure for medical devices

	Fee (euro)
New use of a medicinal product in a medical device	40,050
Known use of a medicinal product in a medical device	22,440
A type I change in the use of a medicine in a medical device	2,500
A type II change in the use of a medicine in a medical device	15,160
Reconsultation of medical devices	15,160
Transfer to MEB as competent authority for a medical device	630
Substance based medical device	24,970

Homeopathic pharmaceutical products

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

Applications	Fee (euro)
Products with an indication or intended for other than oral or external use	3,380
Products with no indication and intended for oral or external use	1,690
Application via MRP with NL=RMS	3,940

Traditional herbal medicinal products

	Fee (euro)
National application	4,930
Surcharge for MRP with NL=RMS	3,940
Change in use of a medicinal product in a medical device	3,650

Annual fee

Medicinal products	Fee (euro)
The rate for the annual fee for marketing authorisations and parallel marketing authorisations, with the exception of marketing authorisations for which the Netherlands acts as RMS	1,590
The rate for the annual fee for marketing authorisations for which the Netherlands acts as RMS	2,020

The annual fee for a marketing authorisation is collected for each medicinal product for which a marketing authorisation is awarded (per RVG number or RVH number.

Homeopathic pharmaceutical products	Fee (euro)
The rate for homeopathic pharmaceutical products	50

In principle, this sum is charged for each registered product (i.e. RVH number), but is charged only once for all strengths in a product range containing the same ingredient(s) from a single marketing authorisation holder.

Herbal medicinal products	Fee (euro)
The rate for (traditional) herbal medicinal products	740

In accordance with Article 54 Section 3, the marketing authorisation holder must pay an annual fee for the (parallel) marketing authorisation.

Package fee and copy DCP application

The term package fee entails that a group of products (each with an individual RVG number) is only billed once at the fee corresponding to the product type of the procedure. In order to qualify for the package fee, certain terms and conditions apply. These can be found in the document Terms and conditions for package fee and reduced fee for copy DCP application - human products.

A DCP copy application is an additional DCP application for the dossier is identical or almost identical to the dossier of the initial application (the original). If certain conditions are met, a reduced fee applies for the DCP copy application. These can be found in the document Terms and conditions for package fee and reduced fee for copy DCP application - human products.

MEB payment conditions

Pursuant to the Medicines Act, a fee is owed for the processing of every application, regardless of the course of this process. The fee for the processing of an application is owed by the applicant at the time of submission of an application. For each marketing authorisation that is maintained, the authorisation holder is liable to pay a recurrent fee on an annual basis.

For payment of the fee for the processing of an application for a (parallel) marketing authorisation, the applicant will receive an invoice once the application has been received. With regard to the annual fee, the authorisation holder will receive an invoice - for the fee owed - in March or April of that year. The marketing authorisation holder must pay a fee for the authorisations that are authorised as from 1 January of the calendar year concerned.

In summary, the payment process of the MEB is as follows. The amount stated on the invoice must be paid within 30 days. Once this period has expired - and the fee has not been paid yet - you will be summoned to pay the amount on the invoice within 30 days. If the invoice has not been paid after this period, the MEB will transfer the invoice to a debt collection agency.

The payment process of the MEB is as follows:

• The term for payment of your invoice is 30 days.
• You must transfer the amount stated on the invoice to bank account number 
  NL11 INGB 0705003485 in the name of CBG/MEB in Utrecht (Swift code / BIC: INGBNL2A).
• Always state the payment reference (invoice number and debtor number) with your payment.

Notice of default: If we have not received full payment from you within 30 days of the date on the invoice, we will send you a reminder (payment reminder). This is considered a notice of default. The MEB retains the right to suspend the processing until the full amount of the invoice has been credited to the MEB bank account.

Reasonable period of time: The payment reminder gives you a further opportunity to pay us the amount on the invoice within 30 days.

Default: If we have not received full payment from you within 30 days of the date on the payment reminder, you will have defaulted on the payment.

If you have not paid the amount on the invoice (in full) after the notice period, you will have defaulted on the payment and the MEB will engage a debt collection agency to recover this amount.

All legal and/or extra-judicial costs, including legal interest, related to the recovery of the invoiced amounts will be charged to you.

Your payment will first go towards reducing the recovery costs, then towards reducing the interest and finally towards reducing the principal debt.

If the unpaid invoice relates to the annual fee and you have defaulted on the payment, the MEB can suspend the marketing authorisation.