Inspection of the pharmacy

The Agency’s objective is to assess whether there are any deviations from the regulatory framework and whether or not this requires action from the licence holder. The supervision can be performed as inspections on-site, as well as administrative supervision.

During the supervision process, the Swedish MPA has the right both to request information and documents from the licence older and the right to access areas and premises that are being used to sell and handle medicinal products.

Administrative supervision

Administrative supervision is an audit of information and/or documents that have been requested or which are submitted to the authority for other reasons.

Inspection

An ‘inspection’ means that one or more inspectors from the Swedish MPA will visit the dispensing pharmacy. The inspection is usually announced in advance but may also be conducted unannounced.

The procedure is as follows:

• licence holder or the quality responsible pharmacist and the dispensing pharmacy’s employees answer questions;
• the inspectors review different parts of the practice, such as instructions and working methods for quality work.
• The inspectors document their observations and decide whether there are any deviations from the regulatory framework.

The inspectors write a report after the inspection.

Opportunity to comment

After an inspection, the inspection report is sent to the licence holder, who then have the opportunity to send feed back to the Swedish MPA.

This may involve:

• commenting on the authority’s findings;
• opposing or commenting on the authority’s assessment that there are one or more deviations from the current regulatory framework in the practice;
• asking questions about any ambiguities or misunderstandings;
• providing information about plans for rectifying the deviations.

The timeframe for comments is limited and will be announced when the inspection report is sent out.

Decision

After the period for comments has passed, the Swedish MPA may decide to close the case immediately after the comments are received, or after a number of conversations if further clarification is required for the Swedish MPA to be able to make a decision. When the Swedish MPA decides what is required in order for the licence holder to rectify a deviation, the decision is communicated as an injunction or a ban. These decision may be combined with a fine that can be imposed if the licence holder does not comply.

In the event of serious deviations and major lack of compliance, the Swedish MPA may withdraw the licence for a pharmacy.

Appeal

The Swedish MPA’s decisions to impose injunctions, bans and withdrawals of licences can be appealed to the Administrative Court in Uppsala within the deadline expressed in the decision. An appeal must be in writing and addressed to the court but first sent to the Swedish MPA by email or posted. Before the appeal is submitted to the Administrative Court, the Swedish MPA will decide on whether the decision can and should be amended.