Stricter regulatory rules and regulations
The development, authorisation, manufacture, sale and supply of medicines and medical devices are subjected to many rules and regulations. These rules and regulations stem mainly from Brussels, are becoming increasingly stringent, require transparency and are enforced at the national level. Regulators can impose high fines and are becoming increasingly active.
Companies in the Life Sciences industry are facing a regulatory challenge, with, for example, rules on market access requiring the right permits, registrations and certification, as well as rules on product requirements.
- production agreements
- product classification
- market access and CE marking
- supply chain & distribution
- advertising and promotional activities (Inspection Board for the Public Promotion of Medicines (Keuringsraad Openlijke Aanprijzing Geneesmiddelen, KOAG) and the Medicines Advertising Code Foundation (Stichting Code Geneesmiddelenreclame, CGR))
- regulatory enforcement / sanctions / compliance
- industry codes of conduct / self-regulation