The Medical Products Agency issues export certificates on request to assist exporters of medicinal products to satisfy the import requirements of other countries. The format of the certificates complies with that specified by the World Health Organisation (WHO), except point 1.3 ”Is this product actually on the market for use in the exporting country?” which is not included, as the Medical Products Agency does not have access to that information.
The certificate can be ordered from the Medical Products Agency with the form available on the website (see hyperlink below). The certificate of a pharmaceutical product (CPP) will provide details about a single named medicinal product for human or veterinary use. A certificate can be issued for a medicinal product for which a Marketing Authorisation application is under consideration or refused or for a medicinal product which is licensed or withdrawn in Sweden. The certificate provides detailed information about the product including the Marketing Authorisation Holder (MAH), the complete composition and the manufacturing site(s).
The MAH or a representative of the MAH can apply for the certificate. The certificate is issued in English only. Certificates for medicinal products applied for through the centralised procedure are only issued by the EMA.
The Medical Products Agency will issue a certificate within 30 days of the arrival of the request. The certificate is issued on specific certificate paper with an MPA stamp assigned. The requesting company is responsible for the legalisation of the certificate when needed; this is not done by the Medical Products Agency.
The fee for issuing one CPP is 950 SEK. The MPA will send an invoice to the applicant after the delivery of the certificate.
The medicinal product may have a different name in the importing country. If so, a statement of this can be attached to the certificate. The statement has to be written on the company’s headed paper, be signed and dated and should state the trade name, pharmaceutical form and strength in both the exporting and the importing country.
If the Summery of Product Characteristics (SmPC) is to be attached to the certificate, the applicant is responsible for the translation of the latest approved Swedish SmPC from Swedish to English. The translated version should be enclosed to the request of the certificate. If the medicinal product is authorised through the mutual or decentralised procedure with Sweden as Reference Member State (RMS), the latest approved English SmPC is already available at the MPA and can be attached to the certificate.