Icelandic Medicines Agency
Granting of pharmacy licences
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The Icelandic Medicines Agency (IMA) grants pharmacy licences and supervises pharmacy licence holders.
Below are guidelines for professionals on the main operational changes relating to pharmacy licences.
New pharmacy
IMA issues pharmacy licences, and operating licences where applicable, once all conditions have been met. At the same time, the agency sends wholesalers a letter with the licence number (E-number) that IMA assigns to the pharmacy, and authorisation is given to purchase medicines from wholesalers.
Each pharmacy licence is limited to the operation of one pharmacy, and the pharmacy licence holder personally bears professional responsibility for the operation of the pharmacy.
A pharmacist may only be granted one pharmacy licence at a time.
Under Regulation No. 1340/2022 on pharmacy licences and pharmacies, the following information must accompany the application:
Name, address, Icelandic ID number (kennitala), telephone number and email address of the applicant
A copy of the applicant's licence to practise, cf. Lög um heilbrigðisstarfsmenn, No. 34/2012 (Health Care Practitioners Act)
Confirmation that the applicant has worked as a pharmacist, with a valid licence to practise in Iceland, for at least 2 years since the licence to practise was issued
Name, address, Icelandic ID number, telephone number and email address of the operating licence holder, if different from the pharmacy licence holder
Confirmation that the prospective pharmacy licence holder and the operating licence holder have agreed to work together on the operation of the pharmacy in accordance with the laws and regulations governing the activity
IMA sends applications for pharmacy licences to the relevant local authority for its opinion. IMA has 3 months to process an application for a new pharmacy.
Pharmacy premises
Pharmacy premises must meet the conditions of Chapter 3 of Regulation No. 1340/2022 on pharmacy licences and pharmacies.
During the application process, IMA also requests the following information:
A drawing of the new 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
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
Information on the staff, their job titles and full-time equivalents at the planned pharmacy
Copies of opinions from the fire safety inspectorate, the health inspectorate and the occupational safety and health authority
When preparations for establishing the pharmacy 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. A pharmacy is considered ready for inspection when work on the premises has been completed, all necessary equipment is operational, and the pharmacy is able to receive deliveries from wholesalers and begin operations.
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 has 4 weeks to process an application for inspection.
Pharmacy in operation
IMA grants a pharmacy licence to an applicant for a pharmacy licence for a pharmacy in operation, provided that the applicant meets the conditions of the Medicinal Products Act and regulations for such a licence.
Under Regulation No. 1340/2022 on pharmacy licences and pharmacies, the following information must accompany the application:
Confirmation that the applicant has worked as a pharmacist, with a valid licence to practise in Iceland, for at least 2 years since the licence to practise was issued
A signed statement from the outgoing pharmacy licence holder relinquishing their pharmacy licence
Confirmation that the prospective pharmacy licence holder and the operating licence holder have agreed to work together on the operation of the pharmacy in accordance with the laws and regulations governing the activity
IMA reserves at least 4 weeks, after all documents have been received, to process an application for a change of pharmacy licence holder, in accordance with Article 16 of the Regulation.
Each pharmacy licence is limited to the operation of one pharmacy, and the pharmacy licence holder personally bears professional responsibility for the operation of the pharmacy. A pharmacist may only be granted one pharmacy licence at a time.
Lapse of a pharmacy licence
A pharmacy licence lapses:
If the licence holder is deprived of their pharmacy licence or their pharmacist's licence
At the end of the year in which the licence holder turns 70; the licence may be extended by one year at a time after that.
If the licence holder ceases to practise.
On the death of the licence holder. However, the estate may operate the pharmacy for six months under the professional management of a pharmacist, subject to IMA's approval
IMA may deprive a licence holder of their pharmacy licence if they breach the provisions of the Medicinal Products Act or other legislation, and the breach is of such a nature that the licence holder must be considered unfit to engage in the sale of medicines.
Loss of the right to practise is governed by Lög um heilbrigðisstarfsmenn, No. 34/2012 (Health Care Practitioners Act), and Regulation No. 1090/2012 on the education, rights and duties of pharmacists and the conditions for obtaining a licence to practise and a specialist licence.
Closure of a pharmacy or pharmacy branch
Pharmacy
When a pharmacy closes, the outgoing pharmacy licence holder, or their deputy, is responsible for ensuring that these guidelines are followed.
The outgoing pharmacy licence holder must inform customers of the pharmacy being closed where the necessary information from the pharmacy's prescription register can be obtained. This may be done by means of a prominent notice or by letter to customers. Customers must be informed in the same way where uncollected prescriptions and medicine balances will be dispensed.
Stocks of medicines and raw materials for the preparation of medicines may be returned to a wholesaler or handed over to another pharmacy, subject to the following: a. Opened packages of medicines and raw materials must not be handed over to another pharmacy and must be sent for destruction in accordance with the applicable rules. The same applies to medicines prepared at the pharmacy. b. Controlled medicines in opened packages must be sent to IMA for destruction. c. If stocks of controlled medicines are handed over to another pharmacy licence holder, the stocks must be recorded and both parties must sign the stock count.
The outgoing pharmacy licence holder must make a written agreement with another pharmacy licence holder on the dispensing of any prescriptions that may remain undispensed at the pharmacy when it closes. The same applies to uncollected medicine balances.
The outgoing pharmacy licence holder must send electronic prescriptions that have been sent directly to the pharmacy to the central prescription gateway.
The outgoing pharmacy licence holder must make a written agreement with another pharmacy licence holder on the retention of the following documents: a. Prescriptions kept at the pharmacy (for example repeat prescriptions and prescriptions for medicines without a marketing authorisation). b. Purchase and expiry records. c. Prescription register. d. Dispensed prescriptions kept at the pharmacy. Forms for the past year recording the monitoring of the pharmacy's operations, such as temperature monitoring of medicine storage, and the controlled medicines register. e. Records of the preparation of medicines at the pharmacy. f. Other electronic data and documents that must be retained and relate to the pharmacy's operations, with the exception of accounting records.
The agreement between the outgoing pharmacy licence holder and the pharmacy licence holder taking over the retention of the documents must state that the documents will be accessible to those entitled to them. Particular care must be taken to ensure that the software needed to process the data is available. All documents that contain personal data or could be misused, and that no longer need to be or are required to be kept, must be securely destroyed. Particular care must be taken to ensure that electronic data is deleted.
An answering machine must be connected to the telephone number of the closed pharmacy for at least six months. The recorded message must state where to seek information about the closed pharmacy.
If a pharmacy branch has been operated by the pharmacy being closed, its operations must cease at the same time, and these rules apply to the pharmacy branch as appropriate. If the pharmacy branch is to be operated from another pharmacy, a new licence must be applied for from that pharmacy.
The outgoing pharmacy licence holder must formally notify IMA of how the matters specified in these rules have been dealt with, no later than the day the pharmacy closes. They must also send IMA a copy of the pharmacy's controlled medicines register for the preceding month, together with a copy of the stock count of controlled medicines if the medicines have been handed over to another pharmacy licence holder, cf. point 3.d.
Pharmacy branch
If a pharmacy licence holder decides to close a pharmacy branch while the parent pharmacy continues to operate, they must notify IMA. The notification must state the date from which operations are to cease.
The pharmacy licence holder must inform customers of the pharmacy branch being closed where uncollected prescriptions and medicine balances will be dispensed and where the necessary information from the pharmacy's prescription register can be obtained. This may be done by means of a prominent notice or by letter to customers.