MANUFACTURER/IMPORTER

MANUFACTURER/IMPORTER

THE MANUFACTURER STATUS

A manufacturer is a pharmaceutical company whose activities are governed by an Opening Authorisation and a GMP (Good Manufacturing Practices) certificate. It must also have at its disposal one or several qualified persons responsible for ensuring that each individual batch has been manufactured and controlled in accordance with the MA and the applicable law.

Article R5124-2 of the Public Health Code

1° Manufacturer, the company or organisations manufacturing medicine, products or objects listed under article L. 4211-1 and paragraph 4° of article L. 5121-1L. 5121-1 for the purpose of their wholesale, their free transfer or their testing on humans.

Manufacturing comprises operations concerning to the purchase of raw material, packaging items, production operations, quality control, batch liberation, as well as to the related storage operations, as defined by the best practices applicable to this activity provided for in article L. 5121-5.

MANUFACTURER/IMPORTER

THE IMPORTER STATUS

An importer is a pharmaceutical company whose activities are governed by an Opening Authorisation and a GMP (Good Manufacturing Practices) certificate. Its activities may be limited to the physical storage of the imported products or also include the control/ release of the imported batches.

Article R5124-2 of the Public Health Code

2° Importer, the company or organisation importing, storing, quality control or the liberation of batches, for the purpose of their wholesale, their free transfer or their testing on humans, of medicine, products or objects listed under article L. 4211-1 and paragraph 4° of article L. 5121-1L. 5121-1 originating from.

a) State that are not members of the European Community, nor parties to the agreement on the European Economic Area

b) Or other Members states of the European Community or parties to the agreement on the European Economic Area when the medicine, products or objects were manufactured by an institution that is not authorised pursuant to article 40 of Directive 2001/83 dated 6 November 2001 on the Community code relating to medicinal products for human use.

MANUFACTURER/IMPORTER

OUR SERVICES

  • Carrying out manual secondary packaging operations in compliance with GMP
  • Confirmation or certification of manufactured or imported lots of EU/MRA or Third Country origin
  • Preparation of the annual PQR on the scope of activities
  • 3 on-site pharmacists
  • Facilitate access to the French market of innovative treatments or products with a special status, such as blood-derived medicinal products, by ensuring that packaging meets local requirements
  • Simplifying the supply chain by acting as a one-stop solution that brings together a wide range of expertise
  • Handling of small volumes that are not attractive to CROs
MANUFACTURER/IMPORTER

OUR ADDED VALUE

  • Integrated service offer
  • Support access to other EU markets for niche products requiring specific labelling
  • Act as your partner for Europe markets with batch release activities