Authorization on the market (AMM)
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A marketing authorisation (AMM) is a marketing permit or
approval given to a manufacturer by the French Agency for the safety of
health products or the European Medicines Agency (EMA) to allow him to market
a "pharmaceutical speciality".
No speciality may be distributed for a consideration or free of charge if
it has not been authorized for marketing.
A specialized medicine or speciality is characterized by the fact that it
is "prepared in advance and presented in a package marked with a special
name" (Article. L 5111-2 of the French Public Health Code). This "special
name" is:
-the International Non-proprietary Name or INN of the active substance assigned
by the World Health Organization (WHO)
- is a name known as a "nickname", accepted to avoid names that
may be too close to one another, leading to confusion.
A Marketing Authorization requires completion of long and expensive series
of tests known as pre-authorization tests: animal toxicology studies to
determine the biological safety of using well defined doses, pharmacodynamics
studies and pharmacokinetic studies (evolution of the drug in the body).
Then the drug passes through the phase of clinical trials on humans, trials
that are closely controlled by legislation, including the "Huriet-Sérusclat"
Law.
The results of these trials are submitted to an advisory committee for the
protection of persons who consent to medical research (Ethics Committee)
which will give ethical advice.
Following this process the marketing authorization is awarded for a period
of five years so as to determine the therapeutic effects and the strict
terms of use. The AMM Committee assesses the beneficial therapeutic effects
provided by the test drug compared to its side effects. The risks are acceptable
only if the potential benefit is significant.
Currently and for many years, the AMM is only granted to medicines whose
effectiveness has been demonstrated.
Any change in the dosage or terms of use will require a new AMM or an addition
to the existing one.
The controls imposed are becoming more and more stringent: tests on raw
materials, in-process controls, control of the finished product (analytical,
pharmacological and clinical testing,), determination of dosages and main
therapeutic indications, studies on stability and bioavailability and research
into side effects. According to the country concerned, Marketing Authorisation
procedures are always complex and variable.