Guideline on use of bulk packages with automated dose dispensing
The Norwegian medicinal product regulation Art 2-2 i) gives an exemption from the requirement for marketing authorisation for bulk packages that are dose dispensed by an automated process.
This guideline is applicable for medicinal products that have a Norwegian marketing authorisation for another package size.
The type of medicinal product/packages sold to the user/patient has to be traceable. Pharmacy sale of dose dispensed medicinal products shall be available for reporting to the Norwegian Institute for Public Health (NIPH) with the imbursement number issued by Farmalogg (the Norwegian imbursement number center).
It is required that the medicinal product traceability is ensured also for medicinal products that do not have a Norwegian marketing authorisation. Foreign packages from the EAA-area may be used.
No standard labelling requirements are applicable.
Companies for automated dose dispensing shall connect the unregistered medicinal products to an existing imbursement number that relates to the biggest package size marketed for the respective authorised medicinal product. It means that the price and refund concerns shall be conducted as for the related existing imbursement numbers for packages authorised in Norway.
Invented Name and strength for these medicinal products are the same as for the authorised medicinal products that the exemption is based on. Note that the exemption is applicable solely for the strengths included in the Norwegian MA of the medicinal product.
Since these packages must have marketing authorisations in another EEA-country, they are to be supplied with the necessary safety features verified up to the end user. The re-packer/manufacturer responsible for the automated dose dispensing is therefore responsible for the mandatory verification of the safety feature.
The Norwegian Medicines Agency shall consider change of this regulatory exemption program, either if it is extensively used so that it influences the medicinal product statistics (FarmaStat, the prescription database (NorPD) etc.) or should it become required for each batch of the medicinal product to be traceable all the way to the patient.