13/14 December 2023
The Danish Health and Medicines Authority (DHMA) has recently updated its "wholesale distribution of medicines within the EU/EEA questions and answers" document. It gives some valuable information for those who distribute medicines in, from and to Denmark. Here are some highlights:
Very important is the fact that the Guidelines on Good Distribution Practice of medicinal Products for human use (EU-GDP Guide) does also apply to veterinary medicines. This is defined in section 13 of the Danish GDP order.
Some paragraphs are interpreted in a more pragmatic way. According to the EU-GDP Guide, a "degree in pharmacy is desirable" for the Responsible Person. In some Member States, this is implemented rather strictly. In Demark though, it is not required that the Responsible Person holds a degree in pharmacy. However the Responsible Person must acquire the necessary competence, for example via courses and seminars. The Responsible Person "must be at the company regularly and to an adequate extent with due consideration to the company's activities".
The Responsible Person does not appear on the wholesale dealer's authorisation. However, the company must inform the DHMA if the Responsible Person is replaced.
The new requirement of the EU-GDP guide regarding management review and monitoring, DHMA expects a procedure for management review and monitoring reflecting the company's level of activity, size and complexity.
Self-inspections must be conducted by the company. It is not acceptable to replace them by an audit performed by another company, for example a contract giver.
Transport of medicines in, from and to Denmark:
DHMA does not require transportation providers that only transport medicinal products to have an authorisation for wholesale distribution (even if products are carried via a transportation hub and stored for a short period).
And who is responsible that the medicinal products are transported in compliance with GDP? That is the supplying wholesale distributor. They must ensure adequate protection of the product during storage and transportation and the compliance of the transportation provider. If a transportation provider is used, a written contract must be place. An audit does not necessarily have to be performed, but the "wholesale distributor must assess whether the contract acceptor has the competence required to carry out the agreed work".
DHMA requires physical segregation for the following medicinal products:
alternatively electronic segregation is only allowed for: