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Ema backdating

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Eudra GMDP is a publicly accessible EU database which contains manufacturing and import authorisations, registration of active substance manufacturers, GMP certificates and non-compliance statements.

The group provides a forum for harmonisation and discussion of common issues, such as: EMA maintains a compilation of GMP and good distribution practice (GDP) inspection-related procedures and forms agreed by all Member States.Active substance manufacturers must comply with GMP.In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP.For more information on the VAMF certification procedure, see Vaccine antigens.The EU has signed mutual recognition agreements on GMP inspections with regulatory authorities outside the EU.Importers of active substances intended for the EU market are also required to register.

In addition, each consignment needs to be accompanied by a confirmation by the competent authority of the country where it is produced that it conforms to GMP standards equivalent to those in the EU, unless a waiver applies.

They must comply with EU GMP to obtain a manufacturing or import authorisation.

They can ensure that they meet all their legal obligations by following the EU GMP guidelines.

Implementation of the mandatory flood insurance purchase requirements of the Flood Disaster Protection Act of 1973 and the National Flood Insurance Reform Act of 94, as amended, is the responsibility of the various Federal agencies that regulate lenders.

Please contact your regulator or lender to determine their requirements.

The EU GMP guidelines provide interpretation of these principles and guidelines, supplemented by a series of annexes that modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic.