A generic medicinal product is a medicinal product which is basically identical to a medicinal product which is already authorised in the European Union (EU). The existing medicinal product is called reference medicinal product or original medicinal product.
The generic medicinal product and the reference medicinal product have:
- the same qualitative and quantitative composition in terms of active substance(s);
- the same pharmaceutical form;
- bioequivalence demonstrated by relevant comparative studies regarding the biological availability.
After the expiration of the patent and the exclusivity period of the original medicinal product, a generic medicinal product may enter the market. The generic medicinal product is distinguished by the content of the dossier on the basis of which the marketing authorisation was granted. For an original medicinal product, companies must submit a dossier containing all toxicological, pharmacological and clinical data on the medicinal product. The marketing authorisation for a generic medicinal product (a medicinal product that has been authorised in a European Union member state for at least ten years and whose patent has expired) is granted on the basis of a ‘summary’ dossier: quality data, reference to results of studies on the reference medicinal product, relevant data on comparable biological availability.
All medicinal products, whether original or generic, with a marketing authorisation meet the same scientific standards, quality, safety and efficiency criteria and are controlled in the same way. However, the appearance, colour and/or taste of the two medicinal products may differ because the composition of the non-active substances or excipients may be different.
This is an important element to take into account for some patients who are allergic to a particular excipient. The prescriber and the pharmacist will consider this for each medicinal product, whether it is generic or original.
Moreover, the full range (pharmaceutical forms, strengths) of the reference medicinal product is not always available as a generic one. The opposite is also true: there are generic medicinal products for which the reference medicinal product is not available in the same form or strength.
All pharmaceutical companies must meet the same strict requirements in order to place a medicinal product on the Belgian market. Belgian and European inspection services check all stages of the production process, from ingredients to the finished and packaged medicinal product. There are no more violations found with generic medicinal products than with original medicinal products.