Quality, laws and regulations at KD

The quality of our services is not a competitive weapon. It is a prerequisite for handling the products involved in our business operations. There are many aspects to quality, not the least of which is safety. This is a particularly important issue in our business.

To run the kind of operations in which we are involved, we have to comply with a number of laws and regulations. The Swedish Medical Products Agency is the controlling authority which ensures that KD complies with the requirements governing the handling of pharmaceuticals. We have a wholesale and manufactory licence. The second of these enables us to re-pack and re-label goods on behalf of our principals. These permits are issued by the Medical Products Agency. The Medical Products Agency also requires us to employ a pharmacist as a Qualified Person. He/she is responsible for ensuring that KD complies with the legislation and requirements that govern the handling of pharmaceuticals.

KD was the first pharmaceutical distributor in Europe to obtain quality certification in accordance with ISO 9002. This took place in 1994. In 2003, we changed to the new quality standard, 9001:2000. KD was also the first company in the pharmaceutical distribution sector to obtain environmental accreditation according to the ISO 14001 environmental standard. This took place in 1999.

Other important laws and regulations that must be taken into account include:
- AFFE, relating to the handling of medical devices
- the information standard SS 627799-1
- the Swedish act relating to the working environment
- the Swedish environmental code and other environmental legislation
- regulations governing the handling of hazardous goods

Moreover, we naturally comply with all the other legislation that generally applies to the running of a company like ours.