Certification of medicinal products - European Medicines Agency …
网页The European Medicines Agency (EMA) issues certificates to confirm the marketing authorisation and good manufacturing practice of medicines for health authorities outside the European Union (EU). Learn how to request, verify and access electronic certificates for human and veterinary medicines.
National registers of authorised medicines | European Medicines …
网页Find links to the national registers of medicines in the EU and EEA countries, including human and veterinary medicines. The registers contain information on medicines authorised in each country, such as SmPC and package leaflet.
EudraGMDP database | European Medicines Agency (EMA)
网页The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates.
Union Register - European Commission - Public Health
网页The Union Register lists medicinal products for human and veterinary use authorised by the EU Commission through the centralised procedure. It also includes information on suspended, withdrawn, refused or adopted products, as well as national and mutual recognition registers.
网页MAs issued only allow the product in question to be marketed by the MAH in that EU Member State, unless the product has been authorised via the centralised procedure in which case a single MA (a Community Authorisation) is granted by the European Commission and is considered valid in all EU Member States.
Certificate of pharmaceutical product - Wikipedia
网页A certificate of pharmaceutical product (CPP) is a document issued by a country of origin to establish the status of a drug product and its applicant. It is used for registration or importation of drugs in other countries …
CERTIFICATION OF SUBSTANCES FOR PHARMACEUTICAL USE
网页2024年7月8日 · Find answers to frequently asked questions about CEP 2.0, the procedure for obtaining a certificate of suitability for substances used in pharmaceutical products. Learn about the requirements, application process, renewals, revisions, public database and …
European Registration Procedures - CEBIS
网页When it comes to the approval of drugs that don’t have to go through the centralized process, individual EU states are free to develop their own systems and protocols. Mutual Recognition Procedure It is possible for drugs that have been given marketing authorization in one member state of the EU to get that same authorization in another ...
Drug Registration in the Eurasian Economic Union (EAEU)
网页Learn how to register your medicinal product in the Eurasian Economic Union (EAEU), a fast-growing pharmaceutical market with five member states. Compare the two pathways for drug registration: mutual recognition and decentralized procedures, and understand the common technical document format.
API Registration - Europa
网页2024年9月12日 · API Registration Certificates are to be entered into EudraGMDP, as referred to in Art. 111 (6) of Directive 2001/83/EC as amended, and article 95 (2) of Regulation (EU) 2019/6. The EudraGMDP database is maintained and …