Notifications of changes

Notification

The Swedish MPA must be notified of any significant changes at least two months before the change is due to take place.

The exception is when said changes are caused by the types of accidents that the licence holder would not have been able to foresee, e.g. fire or water leakage. In such cases, the change must be reported as soon as possible.

How Coronavirus/COVID‍-‍19 is affecting businesses

Changes that require notification

• Changes that concern the licence holder:
  • change of board member at the licence holder’s company
  • sale of the pharmacy to another legal person
• Change to the scope of the practice:
  • Addition of online or other distance sales
  • Pharmacy service point
• Pharmacy practice to be closed down
• Pharmacy relocation
• Changes to the pharmacy layout
• Change of quality responsible pharmacist

When the pharmacy practice closes

Sometimes pharmacies have to be closed down and the practice has to be wound up. It is very important to know what must and what may happen with the pharmacy’s medicinal product stock.

When the pharmacy licence is withdrawn

When a pharmacy practice closes, the Swedish MPA will withdraw the pharmacy’s licence. According to the rules, the pharmacy licence must be valid for the licence holder to be able to purchase, hold and sell medicinal products.

Liquidating stock before licence expires

The pharmacy’s stock needs to be liquidated before the pharmacy licence expires, either by selling the store’s stock to another party or by discarding it. Discarding the stock means not only dealing with logistical challenges such as transport, but also a negative impact on both the environment and medicinal product supply.

The medicinal products must be of satisfactory quality in order for it to be possible to sell.

Risk of unlawful possession of narcotic drugs

If the medicinal product stock has not been liquidated before the licence expires, the former licence holder will not be able to sell the medicinal product stock. This is an issue, especially if the medicinal products are classified as narcotic drugs, as it then means the individual is unlawfully possessing narcotic drugs.

Closure for individual licence holders

One option for licence holders who are shutting down their pharmacy practices is to sell their stock to another pharmacy using a temporary wholesaler licence.

The licence holder must apply to the Swedish MPA for a temporary licence in order to conduct wholesale operations involving medicinal products. In the event of bankruptcy, the application can be submitted by the official receiver.

The Swedish MPA assesses whether or not a temporary wholesale licence can be issued. The licence is normally issued for a period of 4 months and takes effect on the same date that the pharmacy licence expires.

Please contact the Swedish MPA unit for ‘Pharmacies and OTC Retailing’ (Apotek och receptfri detaljhandel) for further information.

Closure of chain pharmacies

If the closing and the receiving pharmacy have the same owner (i.e. licence holder), it is possible to transfer the stock.

In order to do so, the pharmacy must have full traceability of the medicinal product and the quality of the medicinal product must not be affected during transportation.

The licence holder must meet the requirements below and describe how these are to be fulfilled when reporting the  changes to the Swedish MPA.

• The pharmacy must ensure that all medicinal products that are transferred are of satisfactory quality. The medicinal products must be examined and approved by the pharmacist at both the pharmacy that is closing and at the recipient pharmacy. Among other things, the pharmacist must check and ensure that the original packaging is unopened and has maintained its quality and that the remaining shelf life is acceptable.
• The pharmacy must be able to demonstrate that it has a system in place that provides full traceability for all medicinal products that are being transferred between the closing pharmacy and the recipient pharmacy. This traceability must include information about the batch number. Documentation of traceability must be retained and available for internal inspections and for inspections by the Swedish MPA.
• Transportation of the medicinal product must be done in a way that does not impact the quality of the medicinal product or cause loss of the product in any way. Extra caution is advised when transporting narcotic drugs. Written agreements must be made with any third-party providing transportation.

Pharmacies that change owners

There are two types of change in ownership:

1. The licence holding company comes under new ownership.

   This does not require a new licence application for the pharmacy but information about the change must be submitted to the Swedish MPA

2. The pharmacy gets a new licence holder.

   This means that:

   • information about the change must be submitted to the Swedish MPA by the original licence holder, and the existing licence will be withdrawn;

   • a new application for a licence to run the dispensing pharmacy will have to be submitted by the legal person or company that is taking over the pharmacy.