Quality Requirements for IMP

Quality Requirements for IMP

The manufacturer of and/or importer and the party releasing the investigational medicinal products in the EEA/EU must be a pharmaceutical company located in the EEA/EU. A copy of the current pharmaceutical factory operating license or GMP certificate issued by the EU authority supervising the activity must be submitted (Fimea Regulation 1/2007). The license or certificate must cover the manufacture/importation/release in the EEA/EU of the said pharmaceutical form to be used in the trial.  In addition, a notification must be provided concerning the qualified person responsible for the release and certification of the medicinal products for the trial.

In respect of those manufacturers of the investigational medicinal product located outside the EEA/EU, the qualified person shall issue an affirmation containing the information necessary to the Fimea to assess the manufacturer’s GMP compliance and the need for a GMP inspection by the authorities. GMP compliance and the need for inspection is assessed by the Fimea on a case by case basis on the basis of the information provided on the manufacturer and a risk assessment based on the content of the trial. 

 Vaccines as Investigational Products 

In case the vaccines are used in a clinical trial, The Vaccine Safety Unit of the National Institute for Health and Welfare releases the batches of vaccines for use in clinical trials on medicinal products in Finland. For this purpose, it shall be provided with the manufacturer’s own analysis certificates and the relevant batch release certificates for the vaccine batches used in the trials. If a vaccine which has a marketing authorization is used as a reference or as a supplement to a vaccination programme and an EU Official Control Authority Batch Release Certificate is available for the said batch, no other batch documentation is required.