Regulatory Affairs and Pharmacovigilance
The Regulatory Affairs & Pharmacovigilance Department performs all activities related with the registration of medicinal products, medical devices, cosmetics and body care products and food supplements and is focused on submission, management and archive of the regulatory processes, on monitoring and maintenance of the products lifecycle and ensuring regulatory compliance and compliance with the applicable Legislation throughout the process. Additionally, it develops regulatory strategies, establishes contacts and collaborates with the Competent Authorities and other Regulatory Bodies and performs all activities in the scope of Pharmacovigilance and Healthcare Products Vigilance.
Services rendered to third parties:
– Regulatory support and design of regulatory strategies for product registration in diverse markets / countries;
– Preparation of technical dossiers: medicinal products, medical devices and cosmetics and body care products in accordance with the legislation in force;
– Submission and management of all types of regulatory processes (MA applications, variations, renewals, price and reimbursement, among others);
– Preparation of files in eCTD and NeeS formats and submission by national procedure, MRP and DCP;
– Pharmacovigilance Activities (ICSRs/ incident reports, preparation and submission of PSURs, safety type II variations, XEVMPD, among others);
– Know-how acquired on local legislation and submission requirements in exporting countries in which we operate;
– Adaptation and submission of the files according to the submission requirements of the exporting countries, submission of the same and maintenance of their respective marketing authorizations.
Pharmacovigilance is defined by OMS as the detection, record, assessment and understanding of adverse reactions to medicinal products and any other drug-related safety issues. The effective implementation of mechanisms to detect adverse reactions has the purpose of maximizing the benefit and minimizing the risks of the use of medicinal products, encouraging their safe, rational and more effective use.
The Pharmacovigilance and Vigilance of Healthcare Products of Laboratório Edol has the mission to ensure that the safety information of our medicinal products, medical devices, cosmetics and body care products and food supplements is collected in a systematic manner and processed according to ethical and quality procedures, in order to provide to healthcare professionals and patients accurate and up-to-date safety information about our products.
How to notify?
The notifications of adverse reactions/incidents/undesirable effects occurred with our products can be performed by sending the information to the following contacts:
Address: Laboratório Edol – Produtos Farmacêuticos S.A.
Avenida 25 de Abril, 6-6A, 2795-225 Linda-a-Velha – Portugal
Telephone: +351 214158130
Mobile phone: +351 913740949
Fax: +351 21 415 81 31
Protection of personal data: According to the terms of the Portuguese law of Protection of Personal Data in force, we hereby inform that the personal data collected will be treated in an automated manner and will be processed and archived under the responsibility of Laboratório Edol. These data are intended to the fulfillment of legal obligations in matter of Pharmacovigilance and Vigilance of Healthcare Products and their supply is mandatory for that purpose.
Any personal data collected will be processed in a lawful and legal manner and are strictly confidential and are intended to the management of the information concerning adverse reactions/incidents/undesirable effects with our products, namely the fulfilment of the legal obligations of Laboratório Edol in the scope of Pharmacovigilance and Vigilance of Healthcare Products. The data supplied may be disclosed to the Competent Authorities under the applicable legislation in force.
According to terms of the law, the owner of the personal data is entitled to access and rectify its data, by written request addressed to Laboratório Edol, sent to the address “Avenida 25 de Abril, nº6-6A, 2795-225 Linda-a-Velha, Portugal”, to the attention of the Department of Regulatory Affairs and Pharmacovigilance.