Licencia de importación de cosméticos y productos de higiene personal

Revipharm cuenta con una amplia experiencia en la obtención de licencia previa de funcionamiento de instalaciones de importación de cosméticos y productos de higiene personal.

Estas licencias son otorgadas por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) en un plazo de entre 3 y 6 meses que dependerá del periodo de tiempo en el que se efectúe la inspección de instalaciones, en el plazo de 3 meses desde la presentación de la licencia en el registro, la AEMPS emite la licencia de importación condicionada a la posterior visita de inspección.

Pharmacovigilance audits- checklists

The entry into force of the new legislation on pharmacovigilance in July 2012, established legal requirements for marketing authorisation holders to perform audits of their pharmacovigilance systems, including risk based audits of their quality systems. 

Pharmacovigilance audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.

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The audit will include, but not be limited to evaluation of:

Sistema de Farmacovigilancia e implementación del Sistema de Calidad

En el Módulo I de las guías europeas, se define el sistema de Farmacovigilancia:

"A pharmacovigilance system is defined as a system used by an organisation to fulfil its legal tasks and responsabilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect any chance to their risk-benefit balance" 

La creación y mantenimiento del Sistema de Farmacovigilancia, es una de las tantas responsabilidades que debe asumir el TAC (ver post: Pharmacovigilance responsibilities of the MAH at EU).

Regulatory information – Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

18/12/2015

As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance andPharmacovigilance System Master File

At its December 2015 meeting, the European Medicines Agency’s (EMA) Management Board confirmed that the Article 57 database of medicines authorised in the European Union (EU) can now be relied upon to provide the name and contact details of the Qualified Person Responsible for Pharmacovigilance (QPPV) for each authorised medicine in the EU and the location where the Pharmacovigilance System Master File (PSMF) of the marketing-authorisation holder of a given medicine is held.

This endorsement by the Board allows EMA and the national competent authorities in the EU to fully rely on the Article 57 database for this information. This allows all EU regulators to access this information at a single point facilitating their work and helping to coordinate enquiries from regulators to companies and the conduct ofpharmacovigilance inspections.

As a result of reliance on the Article 57 database, for medicines for human use companies will no longer be required to submit type IA variations to notify regulators of changes in relation to the contact details of their QPPV or the location of their PSMF, simplifying processes for the notification of these changes for both companies and regulators.

The simplification will apply from 1 February 2016. From that date, type IA variations for QPPV and PSMF location no longer need to be submitted. In line with legal requirements, the Article 57 database will need to continue to be kept up to date with any changes to products authorised for human use. 

The Article 57 database is a repository of structured and quality-assured information on all medicines for human use that are authorised in the European Economic Area (EEA), whether they are centrally or nationally authorised. EMA established the database in 2012 and it currently contains approximately 500,000 medicines.

The information contained in the database is provided by marketing authorisationholders, based on the legal obligation set out in Article 57 of Regulation 726/2004/EU. The quality of the data is continuously verified by EMA according to a robust quality assurance and control process, established together with the industry.

See LINK

Increasing access to reports on adverse reactions to medicines

Revised EudraVigilance access policy is adopted by EMA Management Board

The European Medicines Agency (EMA) will give increased access to reports on suspected adverse reactions to medicines authorised in the European Union (EU), while guaranteeing that personal data will be fully protected. This is the outcome of a revision of EudraVigilance Access policy, which was adopted by EMA’s Management Board at its December 2015 meeting. The adoption followed a broad public consultation generating close to 400 comments which have been taken into account in the final policy.

EudraVigilance is the European database of all suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA). Managed by EMA on behalf of the EU medicines regulatory network, EudraVigilance receives over one million adverse drug reaction (ADR) reports per year. The large datasets included in the database provide the backbone for the continuous safety monitoring of medicines in the EU.

The Agency has made data from EudraVigilance publically available since 2011. At the time, EMA defined levels of access to information on ADR reports for medicines inEudraVigilance per stakeholder group: for European regulators, for healthcare professionals, consumers and patients, for marketing-authorisation holders and for academia. Information from EudraVigilance on centrally authorised products and substances commonly used in medicines is available through a dedicated public website

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The revised policy takes into account the changes to the system of safety monitoring of medicines introduced by the pharmacovigilance legislation, such as new transparency provisions, the introduction of direct patient reporting across all EU Member States and a simplification of the reporting of adverse reaction reports for pharmaceutical companies.

Key changes include:

• The public will have access to more information, including line listings of the side effect reports and summary presentations for individual adverse reaction reports received inEudraVigilance. While ensuring that patients and those who have sent in reports of suspected side effects are not identifiable, this access represents a significant increase in transparency for the users of medicines;
• Academiawill be able to get extended access to data sets upon request in support of their research activities;
• The Uppsala Monitoring Centre(UMC) of the World Health Organization (WHO) will be added as a new stakeholder group who will be provided with individual case safety reports (ICSRs) originating from within the EEA;
• Medicines regulatory authorities in countries outside the EEA will be provided with data, in line with the WHO dataset, upon request;
• Marketing-authorisation holders of medicines authorised in the EU will be given enhanced access to reports related to their medicines in support of their signal detection and other pharmacovigilance obligations.

These changes will come into effect in the third quarter of 2017 in parallel with EMA implementing a series of technical improvements to the EudraVigilance system.

Data transfer agreement with WHO

To allow the transfer of data on suspected adverse reactions occurring in the EEA, EMA and the WHO concluded an agreement earlier this month. The data will be transferred electronically to WHO’s UMC on a daily basis. The start of this data transfer in 2017 will follow the introduction of the new reporting rules within the EEA which take effect after a successful audit of the improved EudraVigilance system.

The transferred reports on suspected adverse reactions occurring in the EEA will contribute to VigiBase, the WHO Global Individual Case Safety Report database, on behalf of the WHO Programme on International Drug Monitoring. Better global knowledge on the safety of medicines will also help to promote the safe use of medicines for the benefit of patients worldwide.

LINK: EMA

Certificado de libre venta de productos sanitarios

Cualquier empresa (importador, fabricante, distribuidor, agrupador, esterilizador o Representante Autorizado) que quiera exportar productos fuera de la UE, necesitará el certificado de venta libre (free sale certificate) emitido por la AEMPS. En España, la fase de legalización incluirá: 

• Marcado CE y/o Declaración de conformidad en base a la Directiva 93/42 de productos sanitarios.
• Etiquetado e instrucciones de uso (IFU).
• Comunicación de puesta en el mercado para los producto sanitarios clase IIa, IIb y III.
• Registro de responsables de comercialización de productos sanitarios clase I.

Nuevo real decreto de ensayos clínicos

Real Decreto 1090/2015, de 4 de diciembre, por el que se regulan los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos y el Registro Español de Estudios Clínicos. (BOE núm. 307, de 24 de diciembre).

Para acceder a la información: LINK