Competent bodies of EU member states in cooperation with the European Medicines Agency (EMA) ensure adherence to legal requirements for regulating the marketing of medicinal products through multiple announced as well as unannounced inspections. When necessary, samples from the official laboratory or laboratory for validating the quality of medicinal products are tested.
Cooperation is based on exchanging information with the EMA concerning conducted and planned inspections. EU member states and EMA also cooperate in coordinating inspections in third countries.
The competent body of each EU member is responsible for supervising the implementation of the legal framework which regulates the manufacturing, marketing, testing, brokerage and advertising of medicinal products on their territory.
HALMED’s inspection system on the territory of the Republic of Croatia conducts:
- inspections of good manufacturing practice
- inspections of good pharmacovigilance practice