Medicinal products falling within the mandatory scope of the Annex of Regulation (EC) are obliged to apply for a Centralised Procedure:
- Recombinant DNA technology-Controlled expression of genes
- Hybridoma and monoclonal antibody methods
- Biosimilar biological medicinal products which are developed by one of the above Biotechnological processes also fall under the mandatory scope of the centralised procedure
- Advanced therapy medicinal product
- Gene and cell therapy medicinal products
- Tissue engineered products
Also:
Advanced therapy medicinal products, which were legally on the Community market on 30 December 2008, shall comply with the new Regulation no later than 30 December 2011
Tissue engineered products which were legally on the Community on 30 December 2008 shall comply with the new Regulation no later than 30 December 2012
Medicinal products for human use containing a new active substance for which the therapeutic indication is the treatment of any of the following diseases:
- Acquired immune deficiency syndrome
- Neurodegenerative disorder
- Diabetes
- Auto-immune diseases
- Viral diseases
- Orphan medicinal products
- Generic or hybrid of a centrally authorised product
Optional Centralised Procedure:
The following categories may, at the request of the applicant, be accepted for assessment under the centralised procedure:
- An isomer, mixture of isomers, a complex or derivative or salt of a chemical substance previously authorised as a medicinal product in the European Union but differing in properties with regard to safety and efficacy from that chemical substance previously authorised
- A biological substance previously authorised as a medicinal product in the European Union, but differing in molecular structure, nature of source material or manufacturing process
- A radiopharmaceutical substance which is a radionuclide, or a ligand not previously authorised as a medicinal product in the European Union, or the coupling mechanism to link the molecule and the radionuclide has not been authorised previously the European Union
- A medicinal product which constitutes a significant therapeutic, scientific or technical innovation” (i.e.):
- A medicinal product that provides a new alternative to patients in treating, preventing or diagnosing a disease
- A medicinal product development which is based on significant new scientific knowledge or on the application of a new scientific knowledge
- A new technology or a new application of technology is used for the development or the manufacture of the medicinal product
There are also some other special cases where optional centralised procedure application may be sought:
- A medicinal product which does not constitute a significant therapeutic, scientific or technical innovation, but of patient interest at Community level as it addresses a specific health issue, allows access to medicines, or provides another type of contribution to patient care in the Community
- A medicinal product not authorised in the Community on the date of entry into force of the Paediatric Regulation (26 July 2008) and which includes one or more paediatric indication(s) on the basis of studies conducted in compliance with an agreed paediatric investigation plan (PIP)
- Applications for a new paediatric indication, a pharmaceutical form and/or a route of administration for a nationally authorised medicinal product which include results of studies conducted in compliance with an agreed PIP
* Please note that this is only an extract and we strongly advise you to consult with us or other regulatory experts before making applications in Europe.