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Marketing Authorisation Operator

Marketing Authorisation Operator

CSP can endorse the status of the Marketing Authorization Operator on behalf of their customers who are holders of human and animal specialities licenses and having no pharmaceutical structure on the national territory.

 

Drug Safety:

A phone permanence is ensures 24/7/365 by practitioners and pharmacists.

CSP ensure the registration, codification and evaluation of the submitted adverse events.

We follow up reviews on scientific literature and the laying out of up-to-date periodic reports on drug safety.

CSP do a scientific watch on behalf of their customers 

 

Medical Communication:

CSP regularly communicates information to the French Healthcare professionals concerning their queries on the use of the products for which CSP is an AM operator.

exploitant

 

Advertising:

Under the responsibility of the responsible pharmacist CSP control promotional items, validate them and take in charge the submitting of the dossiers for the ANSM (The French National Agency for Medecines and Health Safety).

 

Management of medical samples in accordance with the rules in force.

 

Promotional information activity:

The promotional information activity intended to healthcare professionals is covered by the ‘Charter of the information by canvassing and prospecting for the promotion of drugs’ signed on the 15th October 2014:

Charter for promotional information

 

CSP quality policy with regard to promotional information is part of the general quality approach of the company;

CSP is currently certified within the framework of the promotional information in compliance with the certification reference material in force:

Certificat de qualification CSP pour l'activité d'information promotionnelle

CSP is currently certified for the promotional information activity intended to healthcare professionals working in practices and/or hospitals –certification by Veritas-:

  • Validation of the training tools, participation in training sessions, validation of the sales representatives’ oral presentation
  • Follow-up of the feedback given by the health professionals
  • Organisation of the certification process in cooperation with the MA holder and/or the subcontracting company

 

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Batch recalls:

So as to be able to act as quickly as possible in collaboration with the Public Health Authorities CSP have put in place a kit of procedures to manage the quality defects and the recalling of batches (via Web portals dedicated to quality). 

 

Up-dating of the data base devoted to health professionals (Vidal, ...).

  • Management of subscriptions and a regulatory watch

The acquired experience of CSP allows them to offer advisory services to companies.

 

CSP is a MA 'exploitant' committed to respecting the environment:

Our clients take part in the effort to protect the environment carried out by Cyclamed, the association in charge of the collection and the destruction of non used drugs –expired or not- and brought back by patients to pharmacies www.cyclamed.org.

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