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

The term "Pharmacovigilance" is used to signify a system for monitoring and assessing the safety of medicinal products in order to minimize risk and improve the therapeutic results associated with the use of said products. To achieve this, it is required that medicine adverse reactions should be documented, reported to the competent authorities and assessed.
ELPEN has established procedures to ascertain that:

Information resources are systematically checked
Required measures are applied in case new data emerge
The competent authorities, health professionals and patients are notified of any changes to the product characteristics.

In this context, please report any adverse reactions you might experience while using ELPEN medicines :

Via phone	+30 210 6039326
Via fax	+30 210 6039300
Via email	pharmacovigilance@elpen.gr

While submitting your report, please include as much information as possible, including details of your medical history, any concurrent medications, as well as the dates when the medicines were administered and the adverse reactions were observed.
For any information pertaining to medical issues, please contact us:

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

Please be reminded that, according to the national reporting system of spontaneous events, adverse reactions may alternatively by reported to the National Organization for Medicines, Pharmacovigilance Section, by submitting a Yellow Card report via one of the following channels:

You may submit the Yellow Card online, via EOF's website, at http://www.eof.gr/web/guest/yellowgeneral
You may submit a hard copy of the Yellow Card report via standard mail (no stamp fee) to EOF's Pharmacovigilance Section (284 Mesogeion Avenue, 15562 Cholargos), tel.: +30 213 2040380 or +30 213 2040337
You can also submit the Yellow Card report via fax at +30 210 6549585

Every report counts!