Application for a manufacturing licence

The Medicinal Products Act, No. 100/2020 (in Icelandic only) provides that only those who have obtained a licence from the Icelandic Medicines Agency (IMA) may manufacture medicinal products. Applications for such licences shall be submitted to IMA on the designated form.

Each manufacturing licence applies to the site where the activities are intended to be carried out.

Under the Regulation concerning the Manufacture of Medicinal Products, No. 893/2004 (in Icelandic only), the application shall be accompanied by the following information:

IMA assesses the application on the basis of the documentation submitted and following an inspection at the applicant's premises.

IMA has 90 days from receipt of a new application to process it.

If further information is required, the applicant shall be asked for it in writing, and the deadline for processing the application shall then be extended by the time elapsed from the request for information until it is received by IMA.

When applying for renewal of a manufacturing licence, the applicant shall submit a new application and update the information specified in items 1–11.

IMA issues a manufacturing licence stating the address of the manufacturing site, the licence number, the manufacturing operations the company is permitted to perform and the period of validity of the licence, together with the relevant annexes.

IMA also issues a Manufacturer/Importer Authorisation (MIA) in the European Medicines Agency (EMA) database EudraGMDP, which states the address of the manufacturing site, the licence number and the manufacturing operations the company is permitted to perform.

The MIA has no period of validity but remains valid for as long as the site holds a valid GMP certificate in the same database.

Variation to a manufacturing licence

Licence holders shall apply to IMA for authorisation to make changes to their manufacturing licence concerning the particulars on which the manufacturing licence is based.

IMA has 30 days from receipt of an application for a variation to a manufacturing licence to process it. In exceptional cases, this period may be extended to 90 days.

If further information is required, the applicant shall be asked for it in writing, and the deadline for processing the application shall then be extended by the time elapsed from the request for information until it is received by IMA.

Certificates relating to manufacturing licences

The Icelandic Medicines Agency (IMA) issues several types of certificates for companies holding a manufacturing licence, and the information in them shall be consistent with the company's current licence.

IMA's certification and the layout of its certificates are based on guidelines from the World Health Organization (WHO).

Statement of licensing status of pharmaceutical product(s)

The certificate states whether the medicinal product concerned has a marketing authorisation in Iceland. It gives the name of the medicinal product, the pharmaceutical form, the name of the active substance and the strength, together with the date of issue and the number of the marketing authorisation. Each certificate may cover more than one medicinal product.

GMP certificate (Good Manufacturing Practice)

IMA issues certificates in the European Medicines Agency (EMA) database EudraGMDP.

The certificate specifies the manufacturing operations the company is permitted to perform, the company's status with regard to compliance with GMP and the period of validity based on the date of the last inspection.

See below regarding GMP certificates for laboratories.

CPP certificate (Certificate of a Pharmaceutical Product)

The certificate is issued for medicinal products intended for export and is intended for the authorities in the importing country.

The certificate contains information on the medicinal product together with information on the applicant for the certificate, the marketing authorisation holder of the medicinal product and the manufacturer. Each certificate contains information on one medicinal product only.

Applications for a CPP certificate are submitted via an online form. There are two types of form: Type A for medicinal products with a marketing authorisation in Iceland, and Type B for medicinal products without a marketing authorisation in Iceland that are manufactured in Iceland.

GMP certificates for laboratories

Laboratories can apply for GMP certification; this is done in the same way as an application for a manufacturing licence.

Laboratories applying for GMP certification do not need a manufacturing licence.

List of laboratories with a GMP certificate

Registration for manufacturing, import and distribution

Under Article 25 of the Medicinal Products Act, No. 100/2020 (in Icelandic only), importers and distributors of active substances and manufacturers of active substances in Iceland must register their activities with the Icelandic Medicines Agency (IMA).

Registration of manufacturing of active substances

Under Article 10 of the Regulation concerning the Manufacture of Medicinal Products, No. 893/2004 (in Icelandic only), manufacturers of active substances intended for use in the manufacture of medicinal products must register their activities with IMA. Further guidance on the information to be submitted for registration is given on the relevant registration form.

Changes to the registration of manufacturing of active substances

Every year, manufacturers of active substances must send IMA a list of the changes that have taken place with regard to the information provided in the original registration form. If no changes have taken place, no notification to IMA is required. If changes are considered likely to affect the quality and safety of the active substances manufactured, IMA must be notified without delay.

Registered manufacturers in Iceland