Masterstudiengang "Drug Regulatory Affairs"

Language: English

In the majority of European countries, generic substitution systems have been established giving pharmacists either the right or the duty to replace a prescribed medicinal product by another medicinal product that contains the same active substance.

The term generic substitution is mostly used when addressing the substitution of the original medicinal product by a generic medicinal product. However, the replacement of an original product by the corresponding parallel imported drug, or the exchange of a generic product by another generic drug containing the same active substance may also be possible.
In addition to or instead of generic substitution, many European countries have implemented generic prescription, i.e. INN prescription, giving physicians the option or duty to prescribe pharmaceuticals by their international non-proprietary name (INN). When receiving such a prescription form, the pharmacist can decide, usually in consultation with the patient, which drug to dispense.

Generic substitution and generic prescription are measures that have mainly been introduced to promote the use of generic medicines with the aim to reduce the costs for pharmaceuticals and to relief the public health systems. The marketing of medicinal products, including original, parallel imported as well as generic products, is inevitably being influenced by generic substitution and generic prescription. One aspect is a shift of decision making within the health system in regard to the medicine that is being dispensed.

While the requirements and procedural details for marketing authorisation applications for medicinal products are mainly regulated on a European basis, the laws and regulations regarding substitution of medicinal products are national competence, and as such very heterogeneous within the European Economic Area. Depending on these national regulations, the pharmacist may have to consider certain criteria when substituting a prescribed product, such as same strength, pharmaceutical form, package size, and indication.

The eligibility of generic products to be interchangeable with the corresponding original product or another generic product is therefore influenced by various factors that have already be considered during the planning of the registration strategy with regard to the marketing authorisation application of a generic medicinal product.

The present master thesis gives an overview of the various substitution systems of selected countries of the European Economic Area with a focus on the physicians, the pharmacists and the patients obligations and rights. Furthermore, the consequences of these regulations and guidelines on the application strategies for marketing authorisations of medicinal products are discussed.