Denmark

Companies that distribute, sell or manufacture medicinal products in Denmark must be authorized by Danish Medicines Agency (DMA). In order to be authorized the company must have a person responsible for quality who is to ensure that the activities carried out comply with Danish Good Distribution Practice provision. Companies that distribute medicines are generally inspected every four to five years, however, if the DHMA has reason to believe that something is wrong, the pharmaceutical company is inspected earlier than planned.

Our team of experts at A-consult can support you in:

• Preparing the set of SOPs which describe quality relevant processes and prepare the Technical Agreements needed to enter the Danish Market depending on your setup
• The role as Responsible person, QP and/or QPPV
• The setup of both Quality Management systems and Pharmacovigilance systems
• Plan and prepare audits and inspections within GDP, GMP, GCP and PV
• Ongoing support and outsourcing of services needed for Quality Assurance, Regulatory Affairs and Pharmacovigilance