Exemption from the staffing requirement of the Medicines Act

According to the Medicines Act, as a general rule, no fewer than two pharmacists should be present in pharmacies for the dispensing of prescriptions and giving advice on the proper use and handling of medicines. The law also provides that circumstances in a pharmacy may be such that it is not possible to meet this requirement, either due to limited activity or remote location.

The holder of the pharmacy license must apply to the Icelandic Medicines Agency for an exemption to allow only one pharmacist to be present. The application must be justified in accordance with the considerations outlined in Article 37, paragraph 5 of the Medicines Act.

Delivery

The permit is sent by email to the applicant's email address and, where applicable, also to the email address of the operating license holder.

Cost

If the Icelandic Medicines Agency deems it necessary to conduct an inspection to assess the application, the applicant pays the cost of the inspection in accordance with fee schedule for marketing authorizations, annual fees, and other fees related to medicines, which the Icelandic Medicines Agency collects. In such cases, the applicant is informed about the scope of the work that the Icelandic Medicines Agency estimates will be required for the necessary inspection before it is carried out.
The Icelandic Medicines Agency also charges a fee for issuing permits related to regulated activities under the provisions of the Medicines Act, and the fee follows the current fee schedule.