Generic medicinal product

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, a holder of a marketing authorisation for a generic medicinal product must take account of so-called usage patents.

These usage patents do not protect a medicinal product as such, as a product patent does, but protect a certain, specific use (therapeutic indication or dosage form) of a medicinal product.

The usage patents often apply long after the dossier protection period has ended when generic versions of the medicinal product can therefore be marketed.

The consequence of a usage patient may be that, when marketing generic versions of a medicinal product, the marketing authorisation holder wishes to state fewer indications in the Summary of Product Characteristics (SmPC) and the package leaflet than for the (innovative) reference product. In those instances the marketing authorisation holder of the generic product will remove this information from the SmPC and the package leaflet before the product is marketed so that the indication is not part of the marketing authorisation. The patented indication therefore does not feature in the product information of these generics in the Medicines Information Bank.

In European mutual recognition procedures the product information is set in most cases and includes all information, so also any patented indications. See the Human MRIndex.