TABLE 1.

Glossary of legal terms

Term(s)	Context and explanation
European Union (EU)	A political and economic union of 27 Member States that are located in Europe.
Member State	EU Member States have agreed by treaty to share sovereignty in some aspects of government through the institutions of the EU.
Third country	A country that is not a member of the EU.
Regulation	An EU Regulation is a binding legislative act that must be applied in its entirety in every EU Member State.
Directive	An EU Directive instructs all Member States on a specific goal to be achieved. Member States then have the freedom to devise their national laws to achieve this goal.
National law	A national law is a law devised and enacted in an individual state. EU Directives and Regulations use the phrase “national” in their provisions to denote domestic Member State legislation.
“Civil and criminal liability”	“This Regulation is without prejudice to national and Union law on the civil and criminal liability of a sponsor or an investigator” a And “Where, in the course of a clinical trial, damage caused to the subject leads to the civil or criminal liability of the investigator or the sponsor, the conditions for liability in such cases, including issues of causality and the level of damages and sanctions, should remain governed by national law” b Clinical trial investigators and sponsors are responsible for adhering to applicable legislation, both EU (where this applies) and national. Where legislation allows claims related to breaches to be brought in civil courts, e.g., negligence, this responsibility is termed “civil liability”. Where legislation permits the imposition of a punishment, e.g., administrative fine, or term of imprisonment, this is termed “criminal liability”.
Authorised, legalised	Both terms are commonly used, often interchangeably, in the European clinical trial environment with various meanings, including: (a) the approval of a clinical trial by MPLAs and ethics boards, (b) the approval of a medicinal product(s) for use in particular situations, (c) the approval granted by a national authority to a pharmacy resulting in registration, (d) the approval granted by a national authority to a pharmacy to sell products at a distance in certain circumstances.
“Not acceptable” and “not permitted”	Both terms are commonly used, often interchangeably, in spoken communication where a practice is deemed not to be allowed but is not known to have a specific criminal sanction directly imposed or enacted through legal provision.
Prohibited and illegal	Both words describe practices specifically sanctioned, i.e., having civil sanctions (e.g. administrative fine) or a criminal penalty (e.g. term of imprisonment) against them in legislation.

^a Article 95 Regulation (EU) No. 536/2014 of the European Parliament on clinical trials on medicinal products for human use entered into force on 16 June 2014. https://eur‐lex.europa.eu/legal‐content/EN/TXT/?uri=celex%3A32014R0536. Accessed 3 May 2021.

^b Recital 61 Regulation (EU) No. 536/2014 of the European Parliament on clinical trials on medicinal products for human use entered into force on 16 June 2014. https://eur‐lex.europa.eu/legal‐content/EN/TXT/?uri=celex%3A32014R0536. Accessed 3 May 2021.