Pricing, reimbursement and imports

Commercialisation of medicinal products and medical devices

Medicinal products cannot be placed on the market without having first obtained an approval known as a marketing authorisation (MA) and medical devices require a declaration of conformity and should be affixed with a CE mark before being placed on the market.

However, even when the regulatory requirements for marketing medicinal products and medical devices have been met, commercialisation requires consideration of issues regarding their manufacture, naming, packaging, pricing, distribution and sale.

For an overview of the typical lifecycle of a medicinal product, which sets out the key research, development, manufacture, marketing, sale and post-market steps, see: Lifecycle of a pharmaceutical product—flowchart.

For an overview of the typical lifecycle of a medical device, see: Lifecycle of a medical device—flowchart, which sets out key regulatory stages from concept and prototype design through its manufacture and placing on the market for patient use and post-market surveillance.

Commercial arrangement

The life sciences sector uses a variety of different commercial arrangements to govern the mechanics of manufacturing, selling and distributing products. These arrangements will, typically, also deal with the intellectual property (IP) in