Links to the regulations cited in Annexes 1 to 3 of the Products Licensing Ordinance (MPLO)

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:EN:PDF


Commission Directive 91/412/EEC of 23 June 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1991:228:0070:0073:EN:PDF


Guide to good manufacturing practice for medicinal products for human use and medicinal products for veterinary use of the European Commission (EudraLex, Volume 4:
http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm


Principles and Guidelines for good manufacturing practice in accordance with the convention for the mutual recognition of inspections in respect of the manufacture of pharmaceutical products of 8 October 1970:
http://www.picscheme.org/ / Publication


Special provisions for medicated feedingstuffs: Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1990:092:0042:0048:EN:PDF


Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:FR:PDF


Guidelines on Good Distribution Practice of Medicinal Products for Human Use:
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013XC1123(01)&from=DE


Recommendation of the Council of Europe dated 12 October 1995 (including Appendices) for the manufacture, use and quality assurance of blood components:
https://www.edqm.eu/en/blood-transfusion-recommendations-resolutions-71.html


The technical Appendix to this Recommendation is regularly updated and may be ordered:
Guide to the preparation, use and quality assurance of blood components


https://www.swissmedic.ch/content/swissmedic/en/home/legal/legal-basis/links-to-the-regulations-cited-in-annexes-1-to-3-of-the-products.html