Marketing Authorisation Operator - Centre Spécialités Pharmaceutiques -

In France, Movianto can rely on its pharmaceutical establishment Centre Spécialités Pharmaceutiques (CSP) which for more than 25 years, has acted on behalf of Market Authorisation Holders (MAHs) as Marketing Authorisation (MA) Operator (“Exploitant”). Indeed, CSP benefits from the status of a pharmaceutical establishment, allowing it to be MA Operator for any MAH, domestic or foreign, within the French market. 

What is the status of MA Operator?

The status of MA Operator is a pharmaceutical status specific to France, described in article R 5124-2 3° of the Public Health Code. The MA Operator, responsible for bringing medicines to market in France, must ensure that all the pharmaceutical activities related to the medicines under its charge comply with the requirements in force. 

Furthermore, French legislation places the pharmaceutical responsibility in the hands of a designated pharmacist, the Responsible Person (RP). The presence of an RP is thus required in any pharmaceutical company in France. 

The RP “organises and supervises all the pharmaceutical operations of the company or organisation, and in particular the manufacture, advertising, medical information, pharmacovigilance, follow-up and withdrawal of batches, distribution, import and export of the medicines, products, objects or articles concerned as well as the corresponding storage operations […]”. R. 5124-36 of the Public Health Code. 

The MA Operator activities within CSP/Movianto are therefore under the supervision of the Responsible Person, who guarantees the quality of the medicine and the safety of the patients. 

Value added services

Our complementary services and activities to the AMM operation

 

To better support pharmaceutical companies in selling their medicines in France, CSP/Movianto has developed tailor-made services to offer our customers a turnkey solution: 

Pharmacovigilance carried out by CSP at European level

Support for administrative procedures

(e.g. drug or pharmaceutical product certificates/price certificates)

Registration and monitoring of databases

(e.g. VIDAL)

Expert review of draft annexes

as part of the preparation of an MA variation submission (linguistic adjustment + alignment with ANSM requirements)

Dedicated support for MA Holders

to meet French regulatory standards

France/EMA regulatory watch and product information watch:

- Internal monitoring by our team by carefully monitoring key institutional pages such as ANSM, Journal Officiel, EMA, CMDh, European Commission, and many others. - Targeted monitoring of specific platforms such as government sites, LEEM and others.

Centre Spécialités Pharmaceutiques, a team of dedicated experts

To meet the rigorous requirements of this type of activity, CSP/Movianto has a multidisciplinary team of 12 people in France, including 8 pharmacists.   

With more than 25 years’ experience as a Marketing Authorisation Operator, CSP/Movianto currently has more than 120 proprietary medicinal products in Marketing Authorisation, covering various therapeutic areas. This variety gives CSP/Movianto a wide range of expertise, particularly in early access and compassionate use. 

 

 

The obligations of the Marketing Authorization Operator, as defined in the French Public Health Code, include Pharmacovigilance (Article R5124-2).

As a Marketing Authorisation Operator, Centre Spécialités Pharmaceutiques (CSP) has a qualified team dedicated to carrying out your pharmacovigilance activities in France. This service complies with the French Public Health Code and Good Pharmacovigilance Practices (GVP) in France and in the EU.

CSP supports you in your activities through the operation of its Pharmacovigilance system. We work with a number of expert service providers to meet all your requirements in France and in European Union.

 

Our pharmacovigilance activities at CSP on behalf of Marketing Authorization (MA) Holders include:

  1. The provision of our Pharmacovigilance system, deployed and maintained on a national and European scale. This guarantees the visibility of the Responsible Pharmacist and the Qualified Person for PharmacoVigilance (french RPV and EU-QPPV) for the following activities:
    • Appointment of pharmacovigilance reference contacts in France: the RPV and in European Union: the EU-QPPV 
    • Management of the Pharmacovigilance System Master File (PSMF)  
    • Analysis of key performance indicators (KPI)
    • Pharmacovigilance Quality System
    • Definition and management of roles and responsibilities in Safety Data Exchange Agreements
    • Qualification of partners

 

2. Management of your pharmacovigilance activities :

  • Managing adverse drug reactions and special situations from collection to submission
  • Signal detection
  • Production of non-compliant use reports for France 
  • Risk management, including drafting Risk Management Plans (RMPs) and assessing the effectiveness of additional risk reduction measures
  • Literature monitoring in local language for France and international
  • Production of Periodic Safety Update Reports (PSUR)

 

3. 24/7/365 Helpline

 

As an MA Operator, Centre Spécialités Pharmaceutiques (CSP) responds to requests for information on medicinal, pharmaceutical, scientific and environmental aspects. The teams also handle requests concerning the availability of the products in their care:

  • Comprehensive management of information requests, with needs-based prioritisation.
  • Absolute commitment to responding to every request within the required timeframe.

 

A product quality claim is any anomaly reported to CSP concerning one of its pharmaceutical products. The claim may relate to the pharmaceutical form or packaging of the product concerned.

As the Marketing Authorization Operator, CSP fulfils its obligations by coordinating investigations with the MA Holder and the Manufacturer in order to provide a response to the claimant.

Thanks to the expertise of our teams and the logistics services we also offer, we provide optimal support to Marketing Authorisation Holders. For instance, if an anomaly is detected in the packaging, we can conduct a visual inspection of the units in stock in our warehouses and propose solutions in collaboration with our Manufacturing/rework department.

As an MA Operator, CSP is responsible for managing the pharmaceutical risk of the products entrusted to it. In the event of an identified risk to public health, it must organise and initiate a batch recall, in collaboration with the ANSM if necessary.

Its custodian status means that CSP/Movianto can be highly responsive when it comes to taking action:

  • Management of pharmaceutical and logistical aspects of medication batch recalls to prevent any risk to public health. 
  • Organising batch recalls and coordinating the necessary actions. 
  • Communication and consultation with ANSM.
  • Overall management of pharmaceutical risk, including pharmacovigilance and management of quality claims.

  1. As the MA Operator, CSP is liable for the advertising of medicinal products.  

In order to guarantee compliance with French advertising regulations, CSP assists MA Holders throughout the process of reviewing and validating promotional materials, and submits applications for approval to the ANSM. 

  

      2.  Our certification for managing Promotional Information activity.

The activity of promotional information aimed at healthcare professionals is governed by the Charter on information by canvassing or prospecting aimed at the promotion of medicinal products, signed on 15 October 2014.

CSP’s quality policy for promotional information is part of the company’s global quality approach.

CSP is at present certified for its Promotional Information activity in accordance with the certification standards in force (March 2017):   

CSP, as the MA Operator, takes part in training courses, validates materials and oral presentations, and also monitors feedback from healthcare professionals. Alongside this, CSP organises the certification process and follow-up with entities holding marketing authorisations and/or sub-contracting companies.

Links with our partners

 

As a pharmaceutical company, Centre Spécialités Pharmaceutiques (CSP) has developed partnerships with the sector’s key bodies: LEEM (the French Pharmaceutical Companies Association), GIMRA (the French Health and Pharmaceutical Industries Group) and the French Pharmacists’ Association (Conseil de l’Ordre des Pharmaciens). These partnerships enable access a wide range of information, workshops, commissions and conferences.