marketing authorisation via national procedure

Applicants following the National Procedure will be granted a marketing authorisation that is valid only in the Netherlands. It is granted by the MEB. Furthermore, this marketing authorisation is not based on recognition of another marketing authorisation for the same product awarded by an assessment authority of another EU/EEA Member State. This means that the medicinal product to which the dossier relates can only be placed on the market in the Netherlands.

The National Procedure can also serve as the first phase of a Mutual Recognition procedure if the Netherlands is going to act as the reference member state (RMS) in that procedure.

It is not always possible for applicants to follow the National Procedure. In the case of medicinal products in the category for which the Centralised European procedure is compulsory, that procedure must be followed. In addition, the National Procedure is not available in the case of medicinal product dossiers where the same applicant has already obtained marketing authorisation in one of the other Member States of the EU/EEA or has already submitted an application for marketing authorisation in one of the other Member States of the EU/EEA and the application is under consideration. In the latter case, applicants must follow a Mutual Recognition procedure.

Marketing authorisation for a product
Applicants wishing to follow a National Procedure must submit a marketing authorisation dossier to the MEB Agency. The MEB will assess the risk/efficacy ratio of the medicinal product. The MEB has up to 210 days to reach a final decision. This period may be suspended to allow the company to answer questions. Companies can also give verbal explanations relating to the dossier they have submitted. If the decision is favourable, the Summary of Product Characteristics, the package leaflet and the label text (including layout) will be determined when the marketing authorisation is granted. Decisions to grant national marketing authorisations are recorded in a register of medicinal products.

Medicinal products that have been granted marketing authorisation via the National Procedure must bear the national marketing authorisation number, which starts with "RVG", on their labelling. Please note that medicinal products which receive marketing authorisation under the Mutual Recognition procedure or the decentralised procedure also carry an "RVG number". See the new Dutch Medicines Act (Geneesmiddelenwet) for details of the relevant legislation.

The requirements governing the marketing authorisation dossiers to be submitted in the context of applications under National Procedures vary according to the type of procedure. The National Procedure is divided into applications for:

• Medicinal products with a new active ingredient, including medicinal products with a 'well-established medicinal use'  
• Medicinal products with a known active ingredient / Generic medicinal products
• Line extensions
• Duplex marketing authorisations
• Parallel import
• Replica marketing authorisations
• Medicinal gases as medicinal products

The MEB's policy on applications for marketing authorisation is set out in a number of policy documents. These can be found under Legislation & guidelines and Dossier requirements.

For dossier requirements for medicinal products with a new active substance, please refer to the relevant European Guidelines. These can be found on the European Commission website.