Europe – EMA : Information package for certificates of medicinal products

The purpose of a certificate of a medicinal product (CMP) is to confirm the marketing authorisation status of the medicinal product and that the medicinal product is produced in accordance with Good Manufacturing Practice (GMP) standards.
CMPs are issued in the framework of the World Health Organisation (WHO) certification scheme on the quality of pharmaceutical products moving in international commerce. According to such a scheme, the CMP is intended for use by the competent authority within an importing country when the product in question is under consideration for a product licence that will authorise its importation and sale and when administrative action is required to renew, extend, vary or review such a licence.
The procedures for authorisation and, consequently, certification of medicinal products in the European Union (EU) are complex. The objective of this document is to provide a brief and understandable summary of the arrangements. More detailed information is available in the appropriate EU legislation…