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)