National competent authorities in the EU may requests the nomination of a contact person for pharmacovigilance issues at national level reporting to the EU qualified person for pharmacovigilance (QPPV) as established by the European legislation.
The figure of the Contact Person for Pharmacovigilance in Spain is defined by the Royal Decree 577/2013 which regulates the Pharmacovigilance of Medicinal Products for human use in Spain. In its Article 14, the following requirements are set:
The Marketing Authorization Holder (MAH) must have permanently and continuously a contact person for pharmacovigilance in Spain, and provide the Spanish Medicines Agency the contact details of this person through an electronic system provided for such purpose. The Spanish Medicines Agency will maintain the contact details of these people in a database that will be available to the competent bodies of the Autonomous Communities.
The designated person must have the adequate experience and training to perform their duties.
The local responsible person will assist the EU QPPV in all functions entrusted to her/him and will collaborate in the following functions:
Collect information about suspected adverse reactions for which the company personnel are aware of, ensuring that:
Accurate and verifiable information is obtained
Follow-up information is obtained
Duplicate cases are detected, in collaboration with the Spanish PV System
Medication errors are adequately identified
Transmit any request from the Spanish Agency to the EU QPPV related to the benefit-risk evaluation of a drug and to answer any query about the volume of sales or prescriptions in Spain.
Act as a point of contact to provide information to the Spanish Agency concerning the implementation in Spain of the regulatory measures adopted for safety reasons, as well as the actions taken in Spain regarding the provisions of the risk management plan.
Establish the necessary procedures to ensure the proper functioning of the local pharmacovigilance activities.
Act as a contact person for pharmacovigilance inspections in Spain.
Cooperate with the regional pharmacovigilance centers by providing all available information regarding the notification of suspected adverse drug reactions.
References:
Royal Decree 577/2013, of 26ht of July, regulating the pharmacovigilance of medicines for human use. Accessed through BOE.es on 04-Mar-2021.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating medicinal products for human use. Accessed through ec.europa.eu on 04-Mar-2021.
Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards to pharmacovigilance, Directive 2001/83/EC. Accessed through eur-lex.europa.eu on 04-Mar-2021.
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