Depending on the stage of development at which the classification advice is sought, some of the
parameters or information requested above may not be finalised. In this case, the target profile
and intended product description may suffice.
In addition to the qualitative and quantitative description of the product to be classified, applicants are
encouraged to present their views on the classification of products under development. They should
discuss any aspects supporting or not the applicability of the pharmaceutical framework for the
development and evaluation of the product. Overlapping aspects relevant to medical devices,
cosmetics, human tissues and cells, blood products, borderline medical use or other issues should also
be highlighted if appropriate.
Details of the regulatory status of the product (including medical device/active implantable device,
when applicable), marketing history in EU and non EU countries and information on the current
medical use worldwide are requested to complement the overall understanding on the regulatory
status of the candidate ATMP.
Applicants can include in the request any additional information or bibliographic references to further
substantiate their positions on the classification of their product on the light of legal definitions in force.
i
Article 17(1) of the ATMP Regulation: Any applicant developing a product based on genes, cells
or tissues may request a scientific recommendation of the Agency with a view to determining
whether the referred product falls, on scientific grounds, within the definition of an advanced
therapy medicinal product. The Agency shall deliver this recommendation after consultation with
the Commission and within 60 days after receipt of the request.
(2). The Agency shall publish summaries of the recommendations delivered in accordance with
paragraph 1, after deletion of all information of commercial confidential nature.
ii Directive 2001/83/EC Annex I Part IV: Web link to Directive 2009/120/EC:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:242:0003:0012:EN:PDF
iii
Recital 24 of ATMP Regulation: The Agency should be empowered to give scientific recommendations
on whether a given product based on genes, cells or tissues meets the scientific criteria which define
advanced therapy medicinal products, in order to address, as early as possible, questions of borderline
with other areas such as cosmetics or medical devices, which may arise as science develops. The
Committee for Advanced Therapies, with its unique expertise, should have a prominent role in the
provision of such advice.
iv A medicinal product as defined in Article 1(2) of Directive 2001/83/EC, as amended, is:
(a) Any substance or combination of substances presented as having properties for treating or
preventing disease in human beings;
or
(b) Any substance or combination of substances which may be used in or administered to human
beings either with a view to restoring, correcting or modifying physiological functions by exerting a
pharmacological, immunological or metabolic action, or to making a medical diagnosis"
A biological medicinal product as defined in section 3.2.1.1 (b) of the Annex I to Directive 2001/83/EC:
A biological medicinal product is a product, the active substance of which is a biological substance.
A biological substance is a substance that is produced by or extracted from a biological source and that
needs for its characterisation and the determination of its quality a combination of physicochemical-
biological testing, together with the production process and its control. The following shall be
considered as biological medicinal products: immunological medicinal products and medicinal products
derived from human blood and human plasma as defined, respectively in paragraphs (4) and (10) of
Article 1; medicinal products falling within the scope of Part A of the Annex to Regulation (EEC) No
2309/93; advanced therapy medicinal products as defined in Part IV of this Annex.
Reflection paper on classification of Advanced Therapy Medicinal Products
EMA/CAT/600280/2010 rev.1
19/19