Legislation
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
Commission implementing regulation (EU) No 520/2012 of 19 June 2012:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF
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
Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (taxas de farmacovigilancia):
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2014:189:FULL&from=EN
Guidelines:
Guideline on good pharmacovigilance practices: Module VIII - Post-authorisation safety studies:
Guideline on good pharmacovigilance practices: Module VIII addendum I - Member States' requirements for transmission of information on non-interventional post-authorisation safety studies:
Post Authorisation Safety Study (PASS): questions and answers:
