Tobacco products in the European Union Common Entry Gate (EU-CEG): A tool for monitoring the EU tobacco products directive.

INTRODUCTION: Under the European Union (EU) Tobacco Products Directive (2014/40/EU) (TPD), manufacturers and importers of tobacco products are required to report information to the European Commission (EC) and Member States (MS) on products intended to be placed on the market. We describe the distribution of notifications to the EU Common Entry Gate (EU-CEG) and identify key fields for improvement on reporting cigarettes or roll-your-own (RYO) tobacco. METHODS: A cross-sectional analysis of secondary data reported in the EU-CEG was conducted for tobacco products notified within EU-CEG between June 2016 and October 2019 for 12 EU MS. Analysis of compliance to specific regulations for priority additives that refer to cigarettes and RYO was conducted for 10 EU countries. RESULTS: Overall, 39170 tobacco products were notified. This included 16762 (42.8%) notifications of cigars, followed by cigarettes 11242 (28.7 %), waterpipes 3291 (8.4%), cigarillos (n=1783), pipe (n=1715), RYO (n=1635), chewing tobacco (n=1021), novel tobacco products (n=839), herbal products for smoking (n=535), other (n=258), nasal (n=74) and oral tobacco (n=15). In cigarettes and RYO tobacco products, the proportion of ingredients notified in all countries that contained an unknown Chemical Abstract Services (CAS) number was 3.8% and 2.1%, respectively. The proportion of underreporting flagging of priority additives ranged from 15.9% in Malta to 41.3% in Lithuania, the mean proportion of underreporting of the variable 'priority additive' for the 10 countries together was 24.7%. CONCLUSIONS: In the EU-CEG data base, for the period of analysis, a significant number of product notifications took place while large variations in the number of types of tobacco products notified across EU countries was noted. The timely monitoring of these data is needed so that products non-compliant within the EU-CEG system are assessed.

Productos de tabaco y relacionados: portal europeo EU-CEG / Tobacco products and related: EU-CEG European Portal

OBJETIVO: La Directiva de Productos del Tabaco (2014/40/EU) obliga a los fabricantes e importadores de productos de tabaco y relacionados a notificar a los Estados miembros la comercialización de estos productos, a través del Portal de Entrada Común de la UE (EU-CEG). El objetivo del estudio fue describir los principales datos disponibles en el EU-CEG en España, así como analizar sus implicaciones para las políticas de control del tabaquismo. MÉTODOS: Se realizó un análisis transversal de los datos obtenidos en el EU-CEG para España. El acceso se realizó a través de archivos en formato xml o pdf, descargados del portal o consultados mediante su interfaz. Se describió la distribución de productos, de fabricantes, la presencia de aditivos prioritarios, y la concentración de nicotina en los líquidos. RESULTADOS: En el portal EU-CEG para España existen actualmente 42.736 registros. El 83,7% correspondía a los dispositivos susceptibles de liberación de nicotina (67% de líquidos de recarga, principalmente con concentraciones de 3, 6, 12 y 18 mg). En productos de tabaco destacaron los cigarrillos (5%), los puros (5,9%) y el tabaco para pipa de agua (2,8%). Los productos de hierbas para fumar supusieron el 0,1%. Cinco de los aditivos prioritarios para su vigilancia estaban presentes en más del 75% de los cigarrillos y del tabaco de liar. Existían 44 registros de cigarrillos Slim y 9 de productos novedosos de tabaco. CONCLUSIONES: El portal EU-CEG se ha convertido en una potente herramienta en el control del tabaco. Destacan los retos que requieren un abordaje conjunto e integral en aspectos como el etiquetado y los ingredientes, los cigarrillos Slim y las nuevas formas de consumo

OBJECTIVE: The Tobacco Products Directive (2014/40/EU) obliges manufacturers and importers of tobacco products and related to notify Member States the commercialization of these products through the EU Common Entry Portal (EU-CEG). The objective of this study is to describe the main data available in EU-CEG in Spain and analyze its implications for smoking control policies. METHODS: Cross-sectional analysis of the data obtained in EU-CEG for Spain. The access is done through .xml or .pdf files, downloaded from the portal or consulted through its interface. It describes the distribution of products, manufacturers, presence of priority ingredients, Slim cigarettes and concentration of nicotine in liquids. RESULTS: In the EU-CEG portal for Spain there are currently 42,736 records. 83.7% corresponds to the devices susceptible to nicotine release (67% of refill liquids, mainly with concentrations of 3, 6, 12 and 18 mg). In tobacco products, cigarettes (5%), cigars (5.9%) and water pipe tobacco (2.8%) stand out. Herbal products for smoking account for 0.1%. 5 of the priority ingredients for surveillance are present in more than 75% of cigarettes and rolling tobacco. There are 44 records of Slim cigarettes and 9 novel tobacco products. CONCLUSIONS: The EU-CEG portal has become a powerful tool in tobacco control. We highlight challenges that require a joint and comprehensive approach in aspects such as labeling and ingredients, Slim cigarettes and new forms of consumption

Revisión de la legislación sobre la investigación clínica en el Sistema Nacional Salud y los servicios de farmacia hospitalaria / Review of legislation regarding clinical research in the Spanish health care system and hospital pharmacy services

La convocatoria de ayudas públicas para el Subprograma de Proyectos de investigación clínica en el Sistema Nacional de Salud (SNS) con medicamentos de uso humano pone de manifiesto la necesidad de que los servicios de farmacia hospitalaria incluyan entre sus actividades la fabricación de medicamentos en investigación que son objeto de un ensayo clínico, cuyo promotor sea un investigador o un grupo de investigadores. En este artículo, se analiza la normativa referente a la fabricación de medicamentos en investigación y los requisitos que los servicios de farmacia deben cumplir para poder elaborar, enmascarar o distribuir un medicamento en investigación en el contexto de un ensayo clínico promovido por profesionales del SNS (AU)

The call for public funding for the Spanish Health Care System clinical research with drugs for human use projects Subprogramme highlights the need for hospital pharmacy services to include the manufacture of investigational drugs which are the subject of a clinical trial, developed by either a researcher or a group of researchers, within its activities. This article discusses the legislation concerning the manufacture of investigational drugs and the requirements that the pharmacy services must meet in order to develop, distribute, or conceal an investigational drug in a clinical trial sponsored by a professional from the SHS (AU)

[Review of legislation regarding clinical research in the Spanish health care system and hospital pharmacy services]. / Revisión de la legislación sobre la investigación clínica en el Sistema Nacional Salud y los servicios de farmacia hospitalaria.

The call for public funding for the Spanish Health Care System clinical research with drugs for human use projects Subprogramme highlights the need for hospital pharmacy services to include the manufacture of investigational drugs which are the subject of a clinical trial, developed by either a researcher or a group of researchers, within its activities. This article discusses the legislation concerning the manufacture of investigational drugs and the requirements that the pharmacy services must meet in order to develop, distribute, or conceal an investigational drug in a clinical trial sponsored by a professional from the SHS.