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Medicinal products

A pharmaceutical strategy for Europe
Adopted on 25 November 2020, the Pharmaceutical Strategy for Europe (reader-friendly version) aims at creating a future proof regulatory framework…
Medicines for Children
The Paediatric Regulation has governed the development and authorisation of medicines for paediatric use since entering into force in 2007. Its…
Orphan medicinal products
Patients suffering from rare diseases deserve the same quality of treatment as other patients within the European Union. Given the small numbers of…
Advanced Therapies
Advanced therapy refers to new medical products that use gene therapy, cell therapy, and tissue engineering. They can be used to treat diseases or…
Pharmaceutical Committee
Pharmaceutical Committee, Veterinary Pharmaceutical Committee. The Pharmaceutical Committee is an advisory Committee which was set up by Council…
Clinical trials
Clinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational…
Falsified medicines
Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they…
EU logo
The illegal sale of medicinal products via the Internet is a serious threat to public health and safety as falsified medicinal products may easily…
Good Manufacturing and Distribution Practices
Good Manufacturing Practices (GMP). The manufacture or import of medicinal products is subject to manufacturing or import authorisation. The authorisation holder must comply with the principles and guidelines of good manufacturing practice and use active substances (active pharmaceutical ingredients
Pharmacovigilance
Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of…
Herbal Medicinal Products
EU legislation on pharmaceutical products for human use also applies to traditional herbal medicines. Herbal medicinal products are defined as any…
Personalised medicine
Personalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals…
Pharmaceuticals and the Environment
Environmental Pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem. Article 8c of Directive 2008…
Eudralex
The body of European Union legislation in the pharmaceutical sector is compiled in…
Union Register
The Union Register lists all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing…