Státní ústav pro kontrolu léčiv

Rules Governing Medicinal Products in the European Union

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/

• Volume 2    Notice to Applicants
  • 2A Procedures for Marketing Authorisation
    • Kapitola 1:  Marketing Authorisation
    • Kapitola 2:  Mutual Recognition
    • Kapitola 3:  Community Referral
    • Kapitola 4:  Centralised Procedure
    • Kapitola 5:  Variations
    • Kapitola 6:  Decision Making Procedure for the Adoption of Commission Decisions
    • Kapitola 7:  General Information
  • 2B Presentation and Content of the Dossier
  • 2C Regulatory Guidelines
• Volume 4    Good Manufacturing Practice
• Volume 9    Pharmacovigilance
• Volume 10  Clinical Trials

Guidelines on Good Distribution Practice of Medicinal Products for Human Use  (94/C 63/03) http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/
docs/doc2001/may/gdpguidelines1.pdf

Scientific Guidelines

http://www.emea.europa.eu/htms/human/humanguidelines/background.htm

• Quality Guidelines (Chemical and Herbal)
• Biologicals Guidelines
• Non-Clinical Guidelines
• Clinical Efficacy and Safety Guidelines
• Multidisciplinary Guidelines

Plasma Master File (PMF)

http://www.emea.europa.eu/htms/human/pmf/pmf.htm

Vaccine Antigen Master File

http://www.emea.europa.eu/htms/human/vamf/vamf.htm

Herbal Medicinal Products

http://www.emea.europa.eu/index/indexh1.htm - Herbal Medicinal Products

Orphan medicinal products

http://www.emea.europa.eu/index/indexh1.htm - Orphan Medicinal Products - Orphan Designation

Inspections

http://www.emea.europa.eu/Inspections/index.html

CMD(h)

http://www.hma.eu/cmdh.html