Balancing the objectives of health policy versus industrial policy goals is one of the main challenges facing European regulators in the area of pharmaceuticals. Achieving the twin goals of encouraging innovation and competitiveness while ensuring affordability and availability of medicinal products requires close cooperation between many stakeholders. Future developments, such as the impact of new technologies (e.g., pharmacogenetics), will also need a sound regulatory framework.

The Expert Group on Medicinal Products and Medical Devices deals with all issues related to the incorporation of pharmaceutical legislation into the EEA Agreement. When a decision is made in the EU to approve a medicinal product, the EEA EFTA States take a corresponding decision within 30 days, thereby approving the same product and ensuring a homogenous market. The Expert Group follows new EU initiatives in the field of medicinal products for human use, assesses their respective merits and provides the European Commission with suggestions and comments when deemed necessary.

Pharmaceuticals are covered by Annex II, Chapter XIII of the EEA Agreement.

See also:

DG Health and Food Safety (DG SANTE) - Pharmaceuticals

European Medicines Agency (EMA) - EMA

Senior Officer
Goods Division

+32 22861 764

Seminar on the European Economic Area - Brussels 13 September 2018