The Medicines Authority issues Certificates of a Pharmaceutical Product (CPP) 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).
The CPP will provide details about a single, named medicinal product which may be licensed or unlicensed in Malta and are:
The CPP provides details about the product and its manufacture including (but not limited to) the Marketing Authorisation Holder (MAH), the active ingredients and excipients, the manufacturing and packaging sites and whether or not the product is placed on the market in Malta.
CPPs are generally, but not exclusively, applied for by the MAH or by the MAH representative and/or manufacturer.
The CPP can be requested from the Medicines Authority through the application form.
The certificate is issued in English only. The fee charged varies depending on the number of original copies required and the service level (two working days from the receipt and validation of the application form for fast track applications). Details about charges for issuing certificates can be found in the fees section.
Application for a Certificate of a Pharmaceutical Product
Administrator, Inspectorate and Enforcement Directorate, Medicines Authority
Email: inspectorate.adm@gov.mt
Telephone: (00356) 23439142