When a medicinal product is imported from another European country, this is referred to as parallel import. With parallel import, the medicinal product is marketed in the Netherlands by an importer who has not been designated by the original authorisation holder.
In many cases, the same or nearly the same version of this medicinal product has already been authorised in the Netherlands; this is the so-called Dutch reference medicinal product. The price of a medicinal product may be lower in another Member State. Therefore, it may be economically attractive to market a medicinal product through parallel import. This requires a parallel import marketing authorisation. The parallel importer may apply for such an authorisation to the MEB.
The authorisation procedure for parallel import products does not apply to medicinal products with marketing authorisations issued by the European Commission valid in the entire European Union, a so-called community marketing authorisation.
The parallel product must be interchangeable with the Dutch reference medicinal product. There may be no difference in efficacy and safety.
The following assessment criteria are important:
- The applicant must designate a medicinal product for which a marketing authorisation has been granted in the Netherlands (reference medicinal product). This Dutch reference medicinal product must have a valid marketing authorisation at the time of the application for the parallel import product.
- The qualitative and quantitative composition of the active ingredients of the product for parallel importation must be identical to that of the Dutch reference medicinal product.
- The qualitative composition of the excipient must be identical to, or nearly identical to that of the Dutch reference medicinal product.
- The pharmaceutical form must be identical to that of the Dutch reference medicinal product.
- The package size must preferably be identical to that of the Dutch reference medicinal product; this applies in particular to OTC medicinal products. A different package size is only acceptable if it falls within the same legal status of supply and if the same dosing schedule (period of treatment) can be followed as approved for the Dutch reference medicinal product.
For more information on the assessment, please see the policy document MEB 14: Parallel import: marketing authorisation and maintenance.
In order to accelerate the granting of the marketing authorisation for a medicinal product for parallel importation, the MEB developed an application form. This form must be used for each authorisation application.
Marketing authorisation number
Products for which parallel import marketing authorisations have been granted are given successive authorisation numbers. RVG2//RVG1. RVG2 is a unique number for the relevant parallel marketing authorisation and RVG1 is the authorisation number for the Dutch reference medicinal product.
Electronic structure of parallel applications
The MEB established an electronic format for parallel applications. Since 12 August 2015, applicants have been obliged to use this format. After this date, parallel applications will be handled only if they comply with this new electronic format for parallel authorisations.
The standard was drawn up in cooperation with a number of pharmaceutical companies who have broad experience with parallel applications. First experiences of these companies and the MEB with this new format have resulted in the new structure.
The existing European harmonised formats NeeS and eCTD for electronic submissions are considered to be not suitable for parallel applications. The structure is only suitable for national parallel applications submitted to the MEB.
Structure of electronic dossier
The structure consists of a number of folders with the documents to be submitted in the application. Folders and documents must have the prescribed name.
Withdrawal of parallel marketing authorisation
A request for withdrawal can be made by using the application form ‘Withdrawal of a parallel marketing authorisation’.
You can submit the completed form, accompanied by the required documents, digitally to the MEB. You can submit withdrawal forms for several products at the same time. You must use a separate form for each product.
Parallel import is defined in Article 48 of the Dutch Medicines Act (Gmw). For questions about parallel import or technical questions about the electronic format, please contact the MEB by using the contact form on the MEB website.