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:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c

Guideline on good pharmacovigilance practices: Module VIII addendum I - Member States' requirements for transmission of information on non-interventional post-authorisation safety studies:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c

Post Authorisation Safety Study (PASS): questions and answers:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000134.jsp&mid=WC0b01ac058066e979