| Commission Delegated Regulation (EU) 2022/2239 of 6 September 2022 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use https://eur-lex.europa.eu/legal-content/RO/TXT/HTML/?uri=CELEX:32022R2239 |
| Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC https://eur-lex.europa.eu/legal-content/RO/TXT/HTML/?uri=CELEX:32014R0536 |
| Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council https://eur-lex.europa.eu/legal-content/RO/TXT/?uri=CELEX:32017R0556 |
| Commission Delegated Regulation (EU) 2017/1569 (for multilingual versions, click here) of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections as of enforcement of Regulation (EU) No. 536/2014 on clinical trials) https://eur-lex.europa.eu/legal-content/RO/TXT/HTML/?uri=CELEX:32017R1569 |
| Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance) https://eur-lex.europa.eu/legal-content/RO/TXT/HTML/?uri=CELEX:32022R0020 |
| EudraLex – Volume 10 of the publication “The rules governing medicinal products in the European Union” contains guidance documents applying to clinical trials (Clinical Trials Guidelines) Clinical Trials Guidelines |
| Order of the Minister of Health no. 3390 din 08.11.2022 of 08.11.2022 on approval of the Methodological rules for approval of provisions of Articles 3 (10), 4 (3) and 6 (2) of Emergency Government Ordinance no. 29/2022 regarding the establishment of the institutional framework and the necessary measures to ensure the application of Regulation (EU) no. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, as well as for the amendment of some regulatory acts in the healthcare field. download Annex 1 … download Annex 2 … download Annex 3 … download Annex 4 … download Annex 5 … download Annex 6 … download Annex 7 … download Annex 8 … download Annex 9 … download Annex 10 … |
| Emergency Government Ordinance no. 29 of 23 March 2022 regarding the establishment of an institutional framework and necessary measures for implementation of Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, repeal of Directive 2001/20/EC and amendment of certain healthcare regulations https://legislatie.just.ro/Public/DetaliiDocument/253151 |
| Order of the Minister of Health no. 888 of 25 July 2014 on approval of fees payable to the National Agency for Medicines and Medical Devices for services related to medicinal products for human use |
National Agency for Medicines and Medical Devices of Romania
