A generic medicinal product is a medicinal product that is authorised via an abridged procedure. There are two types of procedures: an application legally based on the stipulations of 10.1 (true generic application) of Directive 2001/83/EC or a request legally based on 10.3 (hybrid application) of the same Directive.
Generally, a complete dossier including pharmacological, toxicological and clinical data must be submitted with a marketing authorisation application. However, a complete dossier is not required when applying for generic medicinal products, in order to prevent unnecessary repetition of pharmacological, toxicological, and clinical human and animal trials. The applicant may refer to the complete dossier belonging to another product, the reference medicinal product, as long as the requirements for the accelerated procedure are met.
The reference medicinal product’s dossier must contain the pharmacological, toxicological and clinical data; thus, the issuing of the marketing authorisation for the reference product must have been based on a complete file. The Board is not required to have access to this data. That is, the reference product need not have obtained marketing authorisation in the Netherlands.
When evaluating requests submitted via the accelerate procedure, the Board must verify that the submitted product is generic with respect to a reference medicinal product. The legal basis for the accelerated procedure may be found in article 10 of European Directive 2001/83/EG.
The term ‘generic medicinal product’ is described in article 10, paragraph 2 under b) of Directive 2001/83/EG:
‘Generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.
The 'reference medicinal product' is a medicinal product authorised under Article 6, in accordance with the provisions of Article 8 (Article 10, paragraph 2 under a) of Directive 2001/83/EG).
Article 10 of Directive 2001/83/EG not only governs the contents of the generic medicinal product’s file, but also lays out rules for the protection data in the reference medicinal product’s dossier (data exclusivity).
The accelerated procedure is described in Article 42 of the Dutch Medicines Act (Geneesmiddelenwet).
Generic medicinal products and usage patents
On the grounds of patent legislation, the marketing authorisation holder for a generic medicine must take account of documents known as usage patents.
These usage patents do not protect a medicine as such, as a product patent does, but rather protect a certain specific application (therapeutic indication or dosage form) of a medicine.
The usage patents often apply long after the data protection period has expired and generic versions of the medicine may thus be brought on to the market.
One consequence of a usage patent may be that, when generic versions of a medicine are brought on to the market, the marketing authorisation holder may include fewer indications in the Summary of Product Characteristics (SmPC) and the package leaflet than for the (innovative) reference product. In these cases the marketing authorisation holder of the product will remove this information from the printed SmPC and package leaflet before putting the generic product on the market.
The MEB evaluates the complete benefit-risk assessment between efficacy and risks, thus including any patented indications. The MEB indicates that the benefit-risk balance for the generic product does not differ from that of the innovator. The product information associated with the registration is included in the MEB Medicines Information Bank. This information is complete, and all indications (including the patented ones) are listed here.
In European Mutual recognition procedures, the product information is also approved including all information in most cases, see the Human MRIndex.
For generic products which have been registered via the centralised procedure (recognisable by an EU number instead of merely an RVG number), no patented indication is included in the approved SmPC nor in the approved patient information leaflet; also, the standard clause mentioned above is not included in the leaflet.
The product information as listed in the MEB Medicines Information Bank is complete. All indications, including patented indications, are mentioned. A new development as of 28 June 2016 is that patented indications are clearly marked as such. More information about this new policy may be found on the page Patented indication.