Counterfeiting of medicinal products has become an increasing threat for patients, healthcare professionals and industry and a concern for EU and national policy-makers. The Directorate-General Enterprise and Industry is consulting all stakeholders and interested parties on key ideas for amending the regulatory framework for medicinal products in an effort to combat the counterfeiting of medicinal products.
For the purpose of this public consultation, which concentrates on sectoral pharmaceutical EU-legislation, the Commission has identified three areas of regulation of medicinal products where improvements to the regulatory framework could make a real contribution to protecting against counterfeit medicinal products.
These measures relate to:
1) Manufacture, placing on the market of medicinal products and related inspections
2) Import, export, transit (transhipment) of medicinal products
3) Manufacture, placing on the market of active substances and related inspections