ObsEva SA (OBSV)

[Frankestin]

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2021
https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-yselty_en.pdf

https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-21-24-february-2022-meeting_en.pdf
OBSEVA IS IN DIALOGUE WITH EMA TO UNDERSTAND AREAS THAT MAY REQUIRE FURTHER CLARIFICATION
IMO very large area!

Article 8
1. In order to obtain an authorization to place a medicinal
product on the market regardless of the procedure established
by Regulation (EEC) No 2309/93, an application shall be made
to the competent authority of the Member State concerned.
2. A marketing authorization may only be granted to an
applicant established in the Community.
3. The application shall be accompanied by the following
particulars and documents, submitted in accordance with
Annex I:
(a) Name or corporate name and permanent address of the
applicant and, where applicable, of the manufacturer.
(b) Name of the medicinal product.
(c) Qualitative and quantitative particulars of all the
constituents of the medicinal product in usual terminology,
but excluding empirical chemical formulae, with mention
of the international non-proprietary name recommended
by the World Health Organization where such name exists.
(d) Description of the manufacturing method.
(e) Therapeutic indications, contra-indications and adverse
reactions.
(f) Posology, pharmaceutical form, method and route of
administration and expected shelf life.
(g) If applicable, reasons for any precautionary and safety
measures to be taken for the storage of the medicinal
product, its administration to patients and for the disposal
of waste products, together with an indication of any
potential risks presented by the medicinal product for the
environment.
(h) Description of the control methods employed by the
manufacturer (qualitative and quantitative analysis of the
constituents and of the finished product, special tests, e.g.
sterility tests, tests for the presence of pyrogenic
substances, the presence of heavy metals, stability tests,
biological and toxicity tests, controls carried out at an
intermediate stage of the manufacturing process).
(i) Results of:
physico-chemical, biological or microbiological tests,
toxicological and pharmacological tests, clinical trials.
(j) A summary, in accordance with Article 11, of the product characteristics, one or more specimens or mock-ups of the
outer packaging and the immediate packaging of the
medicinal product, together with a package leaflet.
(k) A document showing that the manufacturer is authorised
in his own country to produce medicinal products.
(l) Copies of any authorisation obtained in another Member
State or in a third country to place the medicinal product
on the market, together with a list of those Member States
in which an application for authorisation submitted in
accordance with this Directive is under examination.
Copies of the summary of the product characteristics
proposed by the applicant in accordance with Article 11
or approved by the competent authorities of the Member
State in accordance with Article 21. Copies of the package
leaflet proposed in accordance with Article 59 or approved
by the competent authorities of the Member State in
accordance with Article 61. Details of any decision to
refuse authorization, whether in the Community or in a
third country, and the reasons for such a decision.
This information shall be updated on a regular basis.