Q&A 21-30: Similar biological product applications

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21. Do I have to submit samples together with my application?

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

22. Am I, as Applicant, duly established in the EEA?

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

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?

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

24. What batch release arrangements in the EEA are required for my medicinal product?

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

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.

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

References:

26. What shall I submit if my medicinal product contains or consists of genetically modified organisms (GMOs)?

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

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?

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

28. Where on my medicinal product information can I mention a local representative?

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

29. How, to whom and in how many copies shall I submit my dossier?

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

30. When shall I submit my application?

See web-link: EMA Pre-submission guidance for users of the centralised prodedure - List of questions

See submission dates for full applications

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