Regulatory Affairs & Pharmacovigilance

Regulatory Affairs

ELPEN's Regulatory Affairs Department acts as an intermediary between the company and the competent national or international bodies and organizations, such as:

the National Organization for Medicines (EOF)
the European Medicines Agency (EMA) and national Regulatory Authorities in EU member states
National drug approval authorities in non-EU countries
Companies working with ELPEN in the context of regulatory affairs

The Department is responsible for the following activities:

Managing the life-cycle of pharmaceutical products’ Marketing Authorizations (submission of applications to obtain, amend and renew Marketing Authorizations, etc.)
Managing national and EU registration procedures (DCP, MRP) to obtain Marketing Authorizations in the EU
Managing national registration procedures to obtain Marketing authorizations in non-EU countries
Planning/selecting registration procedure for new products
Preparation of the administrative documentation required for the Marketing Authorization submission
Compilation of the Registration Dossiers in e-CTD format
Obtaining approval for and updating the Summary of Product Characteristics (SPC), the package labelling and the Patient Information Leaflet (PIL), according to the guidelines issued by the European Medicines Agency (EMA) and the nationalRegulatory 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
Auditing Registration Dossiers for quality and completeness
Providing Regulatory Affairs support to ELPEN's partners in Greece and abroad as follows:
- Providing information on procedures in force and applicable legislation
- Communicating with the local Regulatory Authorities
- Compilating and submitting Registration Dossiers
- Monitoring Registration procedures/answering queries of the competent Authorities

Pharmacovigilance

Pharmacovigilance is the science and the set of processes that contribute to the continuous monitoring of the safety of medicinal products, with the aim of protecting public health and maintaining a positive benefit-risk balance throughout their lifecycle.

At ELPEN, we systematically collect, evaluate and monitor all information related to the safety of our products, in accordance with applicable regulatory requirements. Through a reliable Pharmacovigilance System, we promptly identify and manage potential risks, contributing to the continuous protection of patients and healthcare professionals.

ELPEN encourages patients, healthcare professionals and other stakeholders to report any suspected adverse reaction or any information related to the safety of its medicinal products. Each report represents an important source of information, contributing to the continuous evaluation and monitoring of the safety of our products.

If you experience any adverse reaction while using an ELPEN medicinal product, or if you have any other information related to the safety of the product, please contact us using the following details:

Via phone	+30 210 6039326
Via email	pharmacovigilance@elpen.gr

Please note that adverse reactions can also be reported directly to the National Organization for Medicines (EOF), via the national reporting system, by completing the Yellow Card.

The Yellow Card can be submitted through one of the following methods:

Electronically, via the EOF website: https://www.eof.gr/kitrini-karta/
By email at: yellowcard@eof.gr
In paper format by post to the EOF Department of Adverse Drug Reactions (284 Mesogeion Avenue, 155 62 Athens, Greece; telephone: +30 213 2040380 or +30 213 2040337).