- 21. Do I have to submit samples together with my application?
- 22. Am I, as Applicant, duly established in the EEA?
- 23. What information relating to the manufacture and batch release should be provided as part of my application? Is it possible to add/replace/remove manufacturing sites during the evaluation process?
- 24. What batch release arrangements in the EEA are required for my medicinal product?
- 25. How shall I submit the information related to the biological active substance?
Full information related to the active substance should be submitted within Module 3.2.S. (Please refer to Question 14. “How shall I present my similar biological medicinal product application (format)?”).
It should be noted, that the CEP procedure (Certification of Suitability of the European Pharmacopoeia) does not apply for direct gene products (i.e. proteins), products obtained from human tissues, vaccines and blood products and preparations.
The EDQM has also decided to exclude from the scope of the certification procedure the products classified as “other biological substances” by the CMD(h). In this respect, the CMD(h) has published an overview of biological active substances of non-recombinant origin.
The reasoning behind this decision is that the characterisation and determination of biological substances require not only a combination of physico-chemical and biological testing, but also an extensive knowledge of the production process and its control.
- 26. What shall I submit if my medicinal product contains or consists of genetically modified organisms (GMOs)?
- 27. What information shall I provide if my medicinal product contains or uses in the manufacturing process materials of animal and/or human origin? When should I submit TSE tables A, B and C?
- 28. Where on my medicinal product information can I mention a local representative?
- 29. How, to whom and in how many copies shall I submit my dossier?
- 30. When shall I submit my application?
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