Certificates

Certificate of manufacturing status (CMS)

This certificate confirms whether named sites meet Good Manufacturing Practice (GMP) or Good Distribution Practices (GDP) requirements on a specified license number. The certificate specifies what operations the company is licensed to perform in accordance with EU guidelines. 

Certificate of a Pharmaceutical Product (CPP)

IMA 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.

Please fill out an application form for CPP certificates.

Statement of licensing status of a pharmaceutical product(s)

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).