Manufacturers

The Medicines Act No. 100/2020, stipulates that a manufacturing licence can only be held by those granted such a licence by the Icelandic Medicines Agency.

An application for a manufacturing licence must be submitted to the IMA on a specific form.

Each manufacturing licence is valid for the planned manufacturing site only.

According to Regulation No 893/2004 on manufacturing of medicinal products the application must be accompanied by the following information:

1. Name, address, ID and Phone number of the firm
2. Name, address, ID and Phone number of the person applying on behalf of the firm
3. Address of the manufacturing site and the location of the quality assurance
4. General description of the planned activity
5. Drawings of premises
6. Summary of main equipment
7. Summary of medicinal products and pharmaceutical forms which are planned to be manufactured
8. Summary of individual steps in the manufacturing process of the medicine(s) which are manufactured at the firm
9. Summary of the main components of the firm’s quality assurance system
10. Name of technical manager and a CV
11. Name of Qualified Person and a CV, if the QP is not the technical manager

The Icelandic Medicines Agency assesses the application based on submitted data and after an inspection at the applicant’s firm. The agency has 90 days from the receipt of a new application to assess it. If further information is needed, it shall be sent in writing to the applicant and the time limit to assess the application is extended accordingly (clock-stop) in line with the time from the request for additional information until its receipt by the agency.

In the case of an application for a renewal of a manufacturing licence, the applicant must submit a new application and update the information stated in points 1-11 above.

The Icelandic Medicines Agency issues a manufacturing licence specifying the address of the manufacturing site, the licence number, the manufacturing operations the company is authorised to perform, the validity period of the license, as well as relevant annexes.

The Icelandic Medicines Agency also issues a Manufacturer/Importer Authorisation (MIA) in the European Medicines Agency (EMA) database known as EudraGMDP. This authorisation includes the address of the manufacturing site, the license number, and the manufacturing operations the company is authorised to perform. The MIA does not have an expiry date and remains valid as long as the operation maintains a valid GMP certificate in the same database.

Application form for license to manufacture medicinal products

The manufacturing licence holder shall apply to IMA for amendments to the manufacturing licence regarding those items, which were the basis of the manufacturing licence.

IMA has 30 days from receipt of the application for amendment to assess it. In specific cases that period can be extended to up to 90 days.

If further information is needed it shall be sent in writing to the applicant and the time limit to assess the application is extended accordingly (clock-stop) inline with the time from the request for additional information until its receipt by IMA.

The Icelandic Medicines Agency issues various types of certificates for companies holding a manufacturing licence, and the information in these certificates must align with the licenced manufacturing operations of the respective company.

This certificate states if the medicinal product possesses a marketing authorization in Iceland. It is not limited to a single product per certificate but is country specific. Details of the product name, dosage form, active ingredients, strength along with issue date and MA/PL number are quoted in accordance with their product license (if applicable).

The Icelandic Medicines Agency issues certificates in the European Medicines Agency (EMA) database known as EudraGMDP.

The certificate specifies the manufacturing operations the company is authorised to perform in accordance with EU guidelines, the company’s compliance status with GMP standards, and the validity period, which is based on the date of the most recent inspection.

Laboratories can apply for GMP certification in the same manner as applying for a manufacturing licence.
Laboratories seeking GMP certification do not require a manufacturing licence.

The Icelandic Medicines Agency issues export certificates for companies that manufacture medicinal products on request to assist them to satisfy the import requirements of other countries. The certificates issued by IMA indicate whether the product or manufacturer to which the certificate applies has met statutory requirements. As a result the certificates do not have an expiry date; they only certify that the manufacturer has met all the requirements at the issue date. The format of certificates complies with that specified by World Health Organization (WHO).

The CPP certificate provides details about a single medicinal product, which may or may not be licensed in Iceland. It provides details about the product and its manufacture including (but not limited to) the marketing authorization holder (MAH), the active ingredients and excipients, the manufacturing site(s) and whether or not the product is placed on the market in Iceland. The certificate provides information on one medicinal product only.

Application form for CPP certificate