The definitions set out in Federal Decree-Law No. 38 of 2024 concerning medicinal products, the profession of pharmacy and pharmaceutical establishments shall apply. The following words and expressions shall have the meanings set out opposite each of them:
Patient Support Programme: a programme aimed at assisting patients in accessing and using medicinal products safely.
Periodic Safety Update Reports: pharmacovigilance documents intended to provide data on adverse reactions and to assess the benefits and risks associated with medicinal products, in order to ensure the ongoing evaluation of the safety and efficacy of medicinal products.
Pharmacovigilance System: The system used by the marketing authorisation holder or their representative to fulfil the legal duties and responsibilities relating to pharmacovigilance, with the aim of monitoring the safety of medicinal products and identifying any changes in the benefit-risk balance.
Pharmacovigilance Master File: A detailed description of the Pharmacovigilance System relating to one or more medicinal products.
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