The Swedish Medical Product Agency’s regulation regarding retail business at community pharmacies has been amended. The amendment, is a re-print and will enter into force on 1 September 2013.
The key amendments are summarised here:
- The requirements regarding the competence and the experience of the person responsible for the medicinal products are amended in such way that prescribers with a different background to those required today, may be appointed. For example, the prescribers shall be able to invoke experience from quality work within other parts of the pharmacy field.
- Computer systems that are used at the pharmacies must be quality assured.
- Pharmacies must adhere to good hygiene,in their operations.
- Pharmacies shall perform controls of the temperature in spaces where medicinal products are stored and the controls shall be documented as well as retained.
- Amendments are made to the requirements of self-monitoring and self-monitoring programs. The requirements that applies to how instructions in the self-monitoring program shall be handled have been clarified.
- The documentation shall be retained for three years rather than five.
In addition, the guidelines to the regulation will be revised. Firstly, the requirements that are made regarding the experience of the person responsible for the pharmaceutical products will be clarified but also other amendments will be exhaustively described in the guidelines. The updated guidelines will be published in connection with the enforcement of the regulations on 1 September 2013.
The amendments of the regulations are broadly based on the findings of the Swedish Medical Products Agency's investigations and supervision of pharmacies.