Category A pharmacy branch

A pharmacist works at a category A pharmacy branch, and its operations are conducted in accordance with Regulation No. 1340/2022 on pharmacy licences and pharmacies.

Category B pharmacy branch

A licence to operate a category B pharmacy branch will only be granted where the distance to a pharmacy or a category A pharmacy branch is long or access to it is difficult.

Medicines may be dispensed on prescription. Dispensing of medicines must comply with Article 33 of Regulation No. 1340/2022. Pharmacy technicians or trained staff may dispense over-the-counter medicines, provided the necessary facilities are in place.

Category C pharmacy branch

A licence to operate a category C pharmacy branch will only be granted where the distance to a pharmacy or a pharmacy branch with a higher level of service is long or access to it is difficult.

Medicines that have been dispensed by a pharmacy may be handed over at a category C pharmacy branch.

The pharmacy licence holder may authorise a defined emergency supply of essential medicines to be kept at a category C pharmacy branch. Dispensing from the emergency supply must comply with Article 33 of Regulation No. 1340/2022. Dispensing from the emergency supply must be recorded in the incident log and specifically identified. The record must state the reason for dispensing from the emergency supply and which employee supplied the medicine.

Under Article 37 of the Medicinal Products Act, a pharmacy licence holder may apply for a licence to operate a branch of their pharmacy in a community where no pharmacy is in operation. If there is already a pharmacy branch in a community where no pharmacy is in operation, a licence will not be granted to operate another pharmacy branch with a lower level of service.

A pharmacy branch is considered part of a pharmacy. It must be operated under the responsibility of the pharmacy licence holder and falls under their pharmacy licence. As a rule, a pharmacy branch should be operated from the nearest pharmacy.

Applications for a licence to operate a pharmacy branch must be sent to the Icelandic Medicines Agency (IMA).

Under Regulation No. 1340/2022 on pharmacy licences and pharmacies, the following information must accompany the application:

• The category of pharmacy branch for which a licence is sought

• Information supporting the need for a pharmacy branch

• The population of the area that the pharmacy branch is to serve

• The distance between the pharmacy and the pharmacy branch

• General information on transport links between the pharmacy and the pharmacy branch

• Information on medical services in the area where the pharmacy branch is to be located

• Information on premises, equipment and staff

• Who will manage the pharmacy branch, and their education and experience of working in a pharmacy.

• A description of the planned operations

• A quality description of communication between the pharmacy and the pharmacy branch, setting out how the objectives of the Medicinal Products Act on the quality and safety of pharmaceutical services will be met, including safety in dispensing prescriptions and the provision of information on the correct use of medicines

• Planned opening hours of the pharmacy branch

• Signage of the pharmacy branch

During the application process, IMA requests the following information in addition to the above:

• An architectural drawing of the pharmacy branch premises, showing the location of the main equipment and describing it. The drawing must be received by IMA at least 8 weeks before the planned opening of the pharmacy branch.

• A quality manual containing detailed procedures for individual tasks relating to the receipt, storage, dispensing and supply of medicines. The quality manual must be received at least one month before the planned opening of the pharmacy branch.

• Information on the staff, their job titles and full-time equivalents at the planned pharmacy branch.

• Copies of opinions from the fire safety inspectorate, the health inspectorate and the occupational safety and health authority.

When preparations for establishing the pharmacy branch are at the final stage and IMA's conditions under Regulation No. 1340/2022 are met, the prospective pharmacy licence holder applies in writing to IMA for an inspection of the premises, equipment and other aspects of the planned operations.

IMA has 4 weeks to process an application for inspection.

After the inspection, an inspection report is drawn up setting out IMA's observations. The observations may be of such a nature that they must be addressed before the licence is granted.

IMA issues a licence to operate the pharmacy branch once all conditions have been met. The agency also notifies wholesalers that the license has been issued.

Licences to operate pharmacy branches are granted for one year at a time.

If the pharmacy licence holder intends to continue operating the pharmacy branch, they must apply for renewal at least three months before the licence expires.

Applications for renewal of a licence to operate a pharmacy branch must be sent to IMA.

Under Regulation No. 1340/2022 on pharmacy licences and pharmacies, the following information must accompany the application:

• Information on premises, equipment and staff

• Who will manage the pharmacy branch, their education and experience of working in a pharmacy

• A description of the planned operations

IMA's approval must be sought if changes are planned to the operations of the pharmacy branch on which the licence is based.