Clinical Trials Directive article 2(d):“a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial…” GCP Directive article 10: “’types of medicinal products’ nclude blood products, immunological products, cell therapy products, gene therapy products, biotechnology products, human or animal extracted products, herbal products, homeopathic products, radiopharmaceutical products and products containing chemical active ingredients” |
