GMPs / GDPs

Consulting services to meet the legal requirements / regulations of Medicines and medical devices

MSI Hellas Consulting Group, having many years of experience in the field of production and distribution of Pharmaceutical products and medical devices, undertakes the provision of consulting services for compliance with the following laws / Regulations:

  • Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
  • ΔΥ8δ/Γ.Π. οικ./1348/04 (ΦΕΚ 32/Β/16-01-04) Principles and Guidelines for good practice in the distribution of medical devices
  • 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

Our services include the development of management systems to meet the requirements of the legislation, internal audits, and the provision of consulting services for obtaining wholesale licenses for medicines.

Our services are addressed to Pharmaceutical Companies, Pharmaceutical Warehouses and Producers & Distributors of Pharmaceutical products and medical devices.