Regulatory Affairs

experience and qualified achievements

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ADELCO Regulatory Affairs Department

ensure the compliance of the pharmaceutical products and the company’s functions with all applicable laws, regulations and guidelines of the pharmaceutical regulatory framework.

Through cooperation with international partners and representative offices of the company, it is the link between the company and the Approval Authorities, both in Greece and at an international level:

  • National Organization for Medicines (EOF)
  • National European Approval Authorities
  • Non-European National Drug Approval Authorities.

The activities of the Department concern the granting and maintaining of the marketing authorizations of pharmaceutical products and it is based on experience, expertise, monitoring of regulatory requirements as well as the efficient management of all stages of the company's products’ life cycle.

Yγεία, ευεξία και την ποιότητα ζωής

Specifically, the activities of the Regulatory Affairs Department are:

  • Managing the life-cycle of pharmaceutical products’ Marketing Authorizations (submission of applications to obtain, amend and renew Marketing Authorizations, etc.)
  • Managing national registration procedures to obtain Marketing authorizations in EU and non-EU countries, in various geographical areas
  • Preparation of the approval dossiers, according to country specific requirements
  • Obtaining approval for and updating the Summary of Product Characteristics (SmPC), the package Labelling and the Patient Information Leaflet (PIL), according to the guidelines issued by the national Regulatory Authorities
  • Drafting and approving package artworks, as well as monitoring their compliance with the guidelines issued by the EU and the Regulatory Authorities in non-EU countries
  • Close cooperation with all business units aiming to help them fully comply with regulatory guidelines that affect their activities and transform regulatory requirements into applicable and operational plans, supporting the company's vision.