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A VERY SPECIFIC EUROPEAN REGULATION IN EUROPE

The legal framework for medicinal products in Europe is defined
in the European directive 2001/83 / CE dated November 6, 2001.

At european level, there are 3 distinct status for the launch
of drugs or medical devices:

• The marketing authorization holder (MAH), responsible for

the marketing of the products, pharmacovigilance, advertising-

medical information, batch monitoring and where applicable,

recalls.

• The manufacturer, with authorization granted by the Member

State in which the manufacturing operations under

his responsibility are carried out.

•The distributor, responsible for wholesale distribution operations.

Exploitation is a pharmaceutical status that applies to commercial operations
for medicinal products in France (Art. R5124-2).
In charge of placing the medicinal product on the market in France, the operator must ensure that all pharmaceutical activities associated with the products for which it is responsible are carried out in accordance with the applicable provisions

PHARMACOVIGILANCE

• A hotline is provided 24/7/365 by doctors

or pharmacists via our partner PV

• MEDIXAL ensures the registration, coding,

and evaluation of adverse event submissions.

• We monitor scientific literature reviews and

the preparation of periodic safety update

reports, as well as a literature watch

MEDICAL INFORMATION

• A hotline is provided 24/7/365 via our partner

• Medical information questions & answers

are approved by MEDIXAL

DISTRIBUTION

• Compliance with the French health code
(CSP = Code de la santé publique)
and the French regulation requirements.

• Ensure that the required storage conditions
for the products are maintained during
transport and that the quality and integrity
of the products are not compromised.

• Follow-up of batches on the French market in

collaboration with the distributor (stock status,

returns of goods).

• Execution of a mock recall in case no recall
occured during the past year.

MONITORING

• Monitoring and oversight on the quality
activities related to Exploitant’s responsibilities.

• Management of the positive list and the sales
reps activities including the audit for example.

ADVERTISING

Advertising material if you want publicity

MEDIXAL ensures :

• The review and approval of promotional and

non-promotional material as required

by the French regulation

• The submission of promotional material to

the Health authorities