Legislation

COMMISSION DELEGATED REGULATION (EU) No 357/2014 of 3 February 2014, supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required.

http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014R0357&from=EN

Decree-Law No. 176/2006, of 30 August

Drug status, as last essay that was given by Decree-Law No. 128/2013 of 5 September:

https://dre.pt/application/dir/pdf1sdip/2013/09/17100/0552405626.pdf

Directive 2001/83/CE:

http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf

Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010:

http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf

Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012:

http://ec.europa.eu/health/files/eudralex/vol-1/dir_2012_26/dir_2012_26_en.pdf

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004:

http://ec.europa.eu/health/files/eudralex/vol-1/reg_2004_726/reg_2004_726_en.pdf

Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012:

http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm#reg