Department of Regulatory Affairs & Pharmacovigilance
The Regulatory Affairs & Pharmacovigilance Department performs all activities related to the registration of medicines, medical devices, cosmetic and body care products, and food supplements, and focuses on the submission, management, and filing of regulatory processes, monitoring and maintenance of the product life cycle, and ensuring regulatory compliance and enforcement throughout the process.
Additionally, it develops regulatory strategies, contacts and collaborates with the Competent Authorities and other Regulatory Entities, and performs all activities in the scope of Pharmacovigilance and Health Product Surveillance.
Services provided to third parties:
Regulatory support and delineation of strategies for product registration in several markets/countries;
Preparation of technical dossiers: medicines, medical devices and cosmetics in accordance with the legislation in effect;
Submission and management of all types of regulatory processes (AIM requests, changes, renewals, prices and reimbursement, among others);
Preparation of dossiers in NeeS and eCTD format and submission by national procedure, MRP and DCP;
Pharmacovigilance activities (incidents/RAMs notification, preparation and submission of PSURs, Type II safety changes, XEVMPD, among others);
Know-how acquired on local legislation and submission requirements in the export countries where we operate;
Adaptation of the dossiers according to the submission requirements of the exporting countries, submission of the same, and maintenance of the respective marketing authorizations.
Pharmacovigilance is defined by WHO as the detection, recording, assessment and understanding of adverse drug reactions or other safety issues associated with medicines. The effective implementation of mechanisms to detect adverse reactions aims to maximize the benefit and minimize the risk of the use of medicines, encouraging their safer, more effective and rational use.
The mission of Pharmacovigilance and Health Product Surveillance at Laboratório Edol is to ensure that safety information in our medicine, medical devices, cosmetic and body care products, and food supplements is systematically collected and processed according to ethical and quality procedures in order to provide health professionals and patients with accurate and up-to-date information on the safety of our products.
How to notify?
Reports of adverse reactions/incidents/undesirable effects with our products can be made by sending the information to our contacts or by filling out the form.
Laboratório Edol – Produtos Farmacêuticos S.A.
Avenida 25 de Abril 6-6A,
2795-225 Linda-a-Velha – Portugal
Under the terms of the Personal Data Protection Act, in its current wording, we inform you that the personal data collected will be processed and filed under the responsibility of Laboratório Edol. These data are intended for compliance with legal obligations regarding Pharmacovigilance and Surveillance of health products, and its provision is mandatory for this purpose.
Any personal data collected will be processed in a lawful and legal manner and are strictly confidential and are intended for the management of information on adverse reactions/incidents/undesirable effects with our products, including compliance with the legal obligations of the Laboratório Edol within the scope of Pharmacovigilance and Surveillance of Health Products. The data provided may be communicated to INFARMED I.P. and other competent entities under the applicable legislation in force.
Under the terms of the law, the holder of personal data is guaranteed the right to access and rectify their data, by means of a written request to Laboratório Edol, to be 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.
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