The Swedish Medical Products Agency (Sw. Läkemedelsverket) has published plans regarding a number of areas that will be specifically supervised during 2013. Included in the plans is a presentation of the prerequisites and the method of work of the respective area of supervision. The purpose is to create an understanding and adherence regarding the applicable rules and to clarify the requirements which - from a risk-based point of view - are in focus for the supervisory work.
According to the director of the Supervision division at the Swedish Medical Products Agency, Ms. Karin Hååg, the plans are being published as a part of increasing the transparency regarding how the Agency is performing its supervisory work and what, in its opinion, needs to be further examined.
The chosen focus areas are based on earlier supervisory efforts but also from indications by citizens, authorities and corporations. The risk based selection is an important starting point.
Ms. Hååg continues by stating that the Swedish Medical Products Agency is constantly developing their supervisory work so that they are supervising “where it provides maximum possible effect for the user”, whether it includes cosmetics or medical products or systems for production or sales of pharmaceutical products.
The Swedish Medical Products Agency has since 2011 published supervisory plans for community pharmacies, which have been appreciated by the industry. The supervisory plans are now published for additional areas, such as the supply of medicinal products to hospitals, narcotics, production and distribution of medicinal products as well as pharmacovigilance. Many different areas have points in common and may be subject to common supervisory efforts; e.g., systems for dispensing prescriptions, the handling of narcotics and teeth whitening products.
Thus, by stating the focus areas that are prioritised, the Swedish Medical Product Agency wishes to achieve a preventing effect, that the designated risk areas are discussed and analysed by the industry and the public, which, according to the agency, contributes to minimising the risk of the occurrence of serious errors that may threaten the security of patients and consumers.
Ms. Hååg concludes that it is more important that the Swedish Medical Products Agency ensures that as many as possible are conducting their businesses in the right way, rather than finding as many faults and deviations as possible.