The marketing authorisation holder in the EU is responsible for the respective pharmacovigilance tasks and responsibilities laid down in Directive 2001/83/EC, Regulation (EC) No 726/2004 and the Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC in order to assure responsibility and liability for its authorised medicinal products and to ensure that appropriate action can be taken, when necessary.
For this purpose, the marketing authorisation holder shall operate a pharmacovigilance system and shall establish and use a quality system that is adequate and effective for performing its pharmacovigilance activities.
We are able to offer a range of services including the following :- Creation and maintenance of Pharmacovigilance System and its Quality System, according to the Good Pharmacovigilance Practices.
- Creation and maintenance of Pharmacovigilance System Master File (PSMF).
- Provision of Qualified Person for Pharmacovigilance (QPPV) in Europe and Local contact person for Pharmacovigilance (Spain).
- Preparation/review and maintenance of Safety Data Exchange Agreements (SDEA), SOPs and Working Instructions.
- Audits on Pharmacovigilance and consulting Health Authority Inspections.
- Risk management plans including Pharmacovigilance Plan, Risk Minimisation Actions Implementation
- Periodic Safety Report writing: PSUR
- Collection and follow-up of spontaneous adverse drug reactions (ADRs) received on behalf of the Marketing Authorisation Holder or HA (Health Authorities).
- Electronic reporting to the Authorities
- Literature reviews (local and international)
- Review of safety sections of educational material
- Participation in meetings with the Competent Authorities.
- Training of PV staff, sales teams, affiliates and distributors
- Quality Assurance Services
Other related links:
Update date: 14-04-2015
El TAC debe disponer de un sistema adecuado para el cumplimiento de sus funciones de farmacovigilancia:
ResponderEliminar1. Elaborar un archivo maestro del sistema de farmacovigilancia.
2. Realizar una auditoría independiente y periódica de su sistema de farmacovigilancia.
3. Tener a su disposición de forma permanente y continua a una persona debidamente cualificada responsable de farmacovigilancia, que será responsable del establecimiento y el mantenimiento del sistema de farmacovigilancia.
4. Evaluar científicamente toda la información, considerar las opciones para minimizar y prevenir riesgos, y adoptar, de ser necesario, las medidas oportunas.
5. Cumplir con las normas de Buenas Prácticas de Farmacovigilancia publicadas por la AEMPS.