Product types and fees marketing authorisation human medicines

The list of product types indicates the various product types handled by the MEB. The choice of product type determines the work flow in which the application will be processed. You will receive a confirmation of receipt, informing you which product type your application will be processed under.

New applications

  Tariff
National application new active substance  

Application via the National procedure

€ 43,900

Application via 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

€ 31,375

Application with existing active substance  

Application via the National procedure

€ 23,060

Application via MRP with NL=RMS

€ 13,810

Application via MRP with NL=RMS repeat use

€  4,400

Application via DCP with NL=RMS

€ 36,870

Copy application via DCP with NL=RMS

€ 15,800

Application via MRP with NL=CMS

€  7,700

Application via DCP with NL=CMS

€ 18,435

Line extensions  

Application via the National procedure

€ 14,980

Application via MRP with NL=RMS

€ 13,810

Application via DCP with NL=RMS

€ 28,790

Application via MRP NL=CMS

€  3,660

Application via DCP with NL=CMS

€ 14,395

Duplex authorisations  

Known active substance

€  5,800

Informed consent  

Known active substance

€  5,800

Application for parallel marketing authorisation  

Per application for a parallel marketing authorisation

€  1,600

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

Tariff 1 - Simple advice

€ 3,500

Regulatory advice

Advice regarding the pharmaceutical or
pre-clinical aspects of the medicinal product

Follow-up advice

Written advice

Tariff 2 - Partial multi-disciplinary scientific advice

€ 6,000

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

Tariff 3 - Complete multi-disciplinary advice

€ 8,000

Advice regarding the clinical, pre-clinical and pharmaceutical aspects
of the medicinal product

Tariff 4 - Customised advice

€ 1,750

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

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).

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

Application via MRP with NL=RMS

€  2,800

Traditional herbal medicinal products

National application

€  3,500

Surcharge for MRP with NL=RMS

€  2,800

Annual fee 2016

Medicinal products

The tariff for the annual fee for marketing authorisations and parallel
marketing authorisations, with the exception of marketing authorisations
for which the Netherlands acts as RMS

€ 1,120

The tariff for the annual fee for marketing authorisations for which
the Netherlands acts as RMS

€ 1,420

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

The tariff for homeopathic pharmaceutical products

€  35

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

The tariff for (traditional) herbal medicinal products

€   515

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 tariff 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 tariff 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 an application for a marketing authorisation or a parallel marketing authorisation, 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.

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.