Responsible person for Supply Chain Management of Medicinal Products (Handling, Storage and Distribution)


Implementation of services of Responsible person for Supply Chain Management of Medicinal Products (Handling, Storage and Distribution)

In compliance with respective EU Member State Medicines Law and EU Directives 2001/83/EC, 2001/20/EC, 2003/94/EC (GMP for medicinal products), 91/412/EEC (GMP for veterinary products), 92/25/EEC (GDP) following services of Responsible person are available:

 

  • Quality System Management
  • preparation and review of Standard Operating Procedures of Quality System Management (SOP)
  • professional consultation on the activities necessary for the notification and obtaining authorization for the provision of medicinal wholesale and retail
  • appointment of Responsible person at respective EU Ministries of Health/Agency for Medicinal Products
  • communication with respective EU Ministries of Health (auditing support, providing responses to Deficiency letters, etc.)
  • handling, storage and distribution of medicinal products (cold chain and ambient temperature)