TABLE 4.
National legislative penalties for breach of “Suitability of Trial Sites” (The Regulation)
| Country | Penalties for breach of section of relevant legislation in third column | Related and linked articles and sections to “suitability of trial sites” in second column |
|---|---|---|
| Bulgaria | (286) “BGN 5000 to BGN 10000 and in case of repeated … commitment …. BGN 10 000 to BGN 20 000.” | (294) “This Act or The Regulation” a |
| Belgium | (44) “imprisonment for a term of one month to two years and/or €500 to €250 000, …” | Art 37 “ Without prejudice to Article 50 of the Regulation, phase I centres may be accredited by the AFMPS” b |
| Italy | (95 of The Regulation) “This Regulation is without prejudice to national and Union law on the civil and criminal liability of a sponsor or an investigator. | (5) “the discipline regarding the suitability of the facilities where the clinical trial is conducted is adapted to the provisions of Regulation (EU) No. 536/2014” c |
| Latvia | (25) “The sponsor shall be responsible … the supply thereof to the clinical trial site (research centre), … the specification of conditions and duration of storage and, where necessary, the dilution liquids and medical devices for the infusion of the medicinal product.” | (25) “Such persons have the duty to observe the storage conditions of the investigational medicinal product.” d |
| Luxembourg |
(19) “Breaches of the provisions of these regulations are punishable (48) … law of August 28, 1998 … Who have obtained … assistance … shall be liable to the penalties … in Article 496 of the Criminal Code,” … “EUR 251 to EUR 2500″. |
Article 1(4) “The provisions of these regulations apply regardless of the environment, hospital or extra‐hospital, in which the research is conducted.” e |
| Malta | 13(2)(b) “the Licensing Authority may exclude from subregulation (1) the process of making changes to the packaging of investigational medicinal products..” | (13(2)(b)) “where this process is carried out by pharmacists or persons authorised to carry out such processes in hospital, health centre or clinic within which solely such investigational medicinal products are intended for use.” f |
| Romania | (181) “If serious and/or persistent deviations from the investigator/institution are identified through monitoring and/or auditing, the sponsor shall stop the institution/investigator's participation in the study; … the sponsor shall promptly inform the competent authorities.” | (164(b)) “Responsibilites of the Monitor …. The suitability of the facilities for conducting the study, including laboratories, equipment and work team for the proper and safe conduct of the study …” g |
| Portugal | (45(1)(c)) “at least €500 and maximum €50 000, and … legal persons, a minimum … €5000 and maximum €750 000″ | (45(1)(c)) “Conduct or continuation of clinical study in a clinical study centre not endowed with adequate material and human resources.” h |
Bulgaria: Article 286 and Article 294 Medicinal Products in Human Medicine Act Amended and Supplemented SG 64/13 August 2019. https://www.bda.bg/images/stories/documents/legal_acts/201910_MEDICINAL%20PRODUCTS%20IN%20HUMAN%20MEDICINE%20ACT.pdf. Accessed 20 December 2020.
Belgium: Article 37, 44 and 45 Federal Medicines and Health Products Agency [C‐2017/12146] May, 7, 2017 – Human Drugs Clinical Trials Act, 1. http://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&table_name=loi&cn=2017050704. Accessed 21 December 2020.
Italy: Article 5 Legislative Decree No. 52 of 14 May 2019. Implementation of the delegation for the reorganization and reform of the legislation on clinical trials on medicinal products for human use pursuant to Article 1, paragraphs 1 and 2 of Law No. 3 of 11 January 2018 (19G00059). https://www.gazzettaufficiale.it/eli/id/2019/06/12/19G00059/SG. Accessed 22 January 2021. Article 95 of Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use. https://eur‐lex.europa.eu/legal‐content/EN/TXT/PDF/?uri=CELEX:32014R0536&from=EN. Accessed 22 January 2021.
Latvia: Regulation 25 of Number 289. Regulations regarding the procedures, for conduct of clinical trials and non‐interventional trials of medicinal products and the procedures for assessment of conformity of clinical trial of medicinal products with the requirements of good clinical practice. https://likumi.lv/ta/en/id/207398‐regulations‐regarding‐the‐procedures‐for‐conduct‐of‐clinical‐trials‐and‐non‐interventional‐trials‐of‐medicinal‐products‐labelling‐of‐investigational‐medicinal‐products‐and‐the‐procedures‐for‐assessment‐of‐conformity‐of‐clinical‐trial‐of‐medicinal‐products‐with‐the‐requirements‐of‐good‐clinical‐practice. Accessed 31 December 2020.
Luxembourg: Regulation 1(3) and 19 Grand Ducal Regulation of 30 May 2005 on the application of good clinical practice in the conduct of clinical trials of medicinal products for human use. http://legilux.public.lu/eli/etat/leg/rgd/2005/05/30/n5/jo. Accessed 31 December 2020. Article 48 of Act of 28 August 1998 on hospital establishments. https://www.cner.lu/Portals/0/loi%20hospitali%C3%A8re%201998.pdf. Accessed 31 December 2020.
Malta: Section 13(2)(b) of Clinical Trials Subsidiary Legislation (S.L. 458/43). http://justiceservices.gov.mt/DownloadDocument.aspx?app=lom&itemid=11281&l=1. Accessed 31 December 2020.
Romania: Article 5(34), 5(57),164(b) and 181 Annex to HCS no. 2/24.10.2017. The Guide on good practice in the clinical trial. https://www.anm.ro/medicamente‐de‐uz‐uman/studii‐clinice/legislatie‐specifica‐pentru‐studii‐clinice/. Accessed 31 December 2020. Note, in Article 5(57), there is a definition for “multi‐centre clinical study” – “the clinical study carried out after a single protocol, but in several centres and therefore by several investigators, and the centres in which the study is conducted can only be found in Romania or in several countries.”
Portugal: Article 45(1)(c) Law No. 21/2014 of 16 April approves the law of clinical investigation. Contra‐ordinations. Approves the law of clinical investigation. Also Article 26(1)(e) Law No. 21/2014 of 16 April approves the law of clinical investigation. The Application for Authorisation is to include: “The identification of the clinical study centres involved and the statement issued by the head of the clinical study centres indicating the terms of their participation”. https://www.infarmed.pt/documents/15786/1068535/036‐B1_Lei_21_2014_1alt.pdf. Accessed 21 December 2020.