Pharmacy License

New pharmacies

Legal requirements for pharmacy premises are presented in Chapter IV in Regulation no. 426/1997 on pharmacy license and pharmacies.

Completed application form for pharmacy license should be sent to the IMA.

Application form for pharmacy licence

According to regulation no. 426/1997, on pharmacy license and pharmacies the following information is required for the application:

  • Name, address, personal identification number, telephone number and e-mail address of applicant.
  • A certified copy of the applicant‘s license as a pharmacist, according to laws on healtcare professionals no. 34/2012.
  • Confirmation that the applicant has worked as a pharmacist and has had a valid pharmacist license for at least 3 years in Iceland.
  • Name, address, personal identification number, telephone number and e-mail address of the operator if he/she is not the superintendent pharmacist.
  • Confirmation that the superintendent pharmacist and the operator of the pharmacy have an agreement in place on the management and operation of the pharmacy according to requirements of the laws and regulations.

 

The IMA forwards the application to the municipal government for review before making the final decision. The Agency has 3 months to consider the application.

During the application process the IMA requests the following additional information from the applicant.

  • A blueprint of the pharmacy premises, where locations of suitable equipment are outlisted as well as description of the facilities. The blueprints should be sent to the IMA at least 8 weeks before scheduled opening of the pharmacy.
  • Quality manual, which contains detailed standard operating procedures regarding reception, storage, handling and delivery of medicines. The quality manual should be sent at least one month before scheduled opening of the pharmacy.
  • Information about job titles, positions and employees of the pharmacy.
  • Copies of reviews from the fire safety inspectors (ice. Eldvarnareftirlitið), the Environmental and public health office (ice. Heilbrigðiseftirlitið) and Administration of occupational safety and health ( ice. Vinnueftirlitið).

 

With preparations for the opening of the new pharmacy in the final stages and all requirements of the IMA fulfilled according to regulation nr. 426/1997, the applicant must formally request an IMA inspection of premises, facilities and activities. A pharmacy is considered ready for inspection when all equipment and facilities have been set up and are ready for operation and the pharmacy  is ready to receive supplies from wholesalers and sell to customers.

After the inspection, the IMA sends its comments to the applicant for review. In some cases the applicants premises or facilities may require some improvements and alterations before the pharmacy is opened.

The IMA has 4 weeks to conclude its inspection after the request for inspection is received.

The IMA grants pharmacy license and operating license as appropriate, when all requirements have been fulfilled. The agency also informs medicinal wholesalers of the new pharmacy and thereby grants it permission to order medicinal supplies from the wholesalers.

Each pharmacy license is limited to one pharmacy and the superintendent pharmacist is professionally responsible for the pharmacy‘s operation.

A pharmacist can only be responsible for a single pharmacy at any given time.

Pharmacy in operation

The IMA grants an applicant pharmacy license for a pharmacy in operation if the applicant meets all the legal requirements for such a license.

An application form for a pharmacy license for a pharmacy in operation should be sent to the IMA.

Application form for a pharmacy in operation

According to Regulation no. 426/1997 on pharmacy license and pharmacies the application should include the following information:

  • Confirmation that the applicant has a valid pharmacist license and has worked as a pharmacist for at least 3 years since the license was issued.
  • Signed statement from the former superintendant pharmacist where he/she resigns from his/her post.
  • Confirmation that the superintendent pharmacist and the operator of the pharmacy have an agreement in place on the management and operation of the pharmacy according to requirements of the laws and regulations. This only applies if the operator of the pharmacy is not the superintendent pharmacist in the pharmacy.

 

The IMA reserves the right to at least 4 weeks to review the application after all data has been submitted.

Each pharmacy license is limited to the operation of a single pharmacy and the superintendent pharmacist is responsible for the professional operation of the pharmacy.

A pharmacist can only hold a single pharmacy license at any given time.

Pharmacy license is withdrawn:

  • If the licensee is deprived of his/her license as a pharmacist or his/her license to run a pharmacy.
  • At the end of the year when the licensee reaches the age of 70. The IMA may grant the licensee one year extension after that period.
  • If the licensee resigns.
  • If the licensee dies. The estate of the deceased, can however operate the pharmacy with a special permit from the IMA for additional 6 months. This permit is only granted if the pharmacy then operates under the professional leadership of another pharmacist.

 

The IMA has the legal authority to deprive a licensee his pharmacy license if he violates the provisions of the Medicinal Products Act, No 93/1994 or other acts or regulations and the offense is considered serious enough that licensee is considered unfit to operate the pharmacy. Refer to Chapter V in the laws on pharmacists No. 35/1978 on the loss of professional license.

Closing a pharmacy

See instructions (in icelandic).