TSE requirements

Directive 2001/83/EC and Directive 2001/82/EC of the European Parliament and of the Council apply. These directives indicate that specific measures should be in force concerning the prevention of the transmission of animal spongiform encephalopathies (materials from ruminant origin). At each step of the manufacturing process, the applicant must demonstrate the compliance of the materials used with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy via Medicinal Products.

Demonstration of compliance with the said Note for Guidance can be done by submitting either, preferably a certificate of suitability to the relevant monograph of the European Pharmacopoeia that has been granted by the European Directorate for the Quality of Medicines or by the supply of scientific data to substantiate this compliance.

Relevant information about TSE and the associated requirements can be found as follows:

• Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3). Official Journal of the European Union (2011/C 73/01)
• European Pharmacopoeia monograph 5.2.8. Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. This monograph is identical to the aforementioned Note for guidance. European Pharmacopoeia 7.04, European Directorate on the Quality of Medicines and Healthcare (EDQM).

Please contact the Pharmacotherapeutic group to which your product belongs for more details and to discuss issues relating to a particular dossier.