For licensed pharmaceutical products Certificates of Analysis (CoAs) are issues with each new batch that is supplied to the market. As pharmaceutical products are licensed by an international or national authority the manufacturing processes and quality + safety guidelines for each product are submitted to the authority before a marketing authorisation is granted to the manufacturer. In Europe, the EMA (European Medicines Agency) is the regulatory authority with which all EU medicines are registered. During the registration process, the applicant submits all necessary documents to assess the safety and efficacy of the manufacturing process. Detailed information on many aspects of the manufacturing, handling, storage and distribution process is kept at the Agency. The Agency assigns an EU registration number under which each product can be uniquely identified.
Once the Agency has granted the applicant manufacturing and distribution rights, all processes described to the Agency must be maintained and followed. However, the holder of the manufacturing and distribution licence (authorisation) is not obliged to provide further documentation when reselling his medicines to hospitals, wholesalers or pharmacies. This includes the certificate of analysis. The manufacturer is free to provide a CoA to the customer.