The classification as a “medical device” in a Member State is not an obstacle for it to be reclassified as a “medicinal product”
Judgment of the Court of Justice of the European Union (ECJ), of 3 October 2013, in case C-109/12
CAPSULAS Nº 149
Background In 2008, the Finnish healthcare authority in Finland decided to reclassify “Gynocaps” (vaginal capsule containing live lactobacilli and that is intended to restore balance to bacterial flora in the vagina) as a “medicinal product”. Until then, such product had been marketed in Finland as “medical device” bearing a CE marking. The Finnish authority based... Read More
The door is open to holding the distributor responsible for damage caused by a product sold with incomplete instructions for use
Judgment of the Provincial Court of León, of 29 November 2013, number 459/2010
CAPSULAS Nº 149
Background A patient suffered an episode of rejection and intolerance to the medical device ‘Bio-Alkamid’ (reticulated prosthetic polymer of poli alkylamide), therefore it was necessary to extract it. The leaflet did not contain sufficient information about the possibilities of extraction. This patient suffered damages and lodged a complaint against the companies responsible for the marketing of... Read More
La imagen de la Administración
El Global
La imagen es importante, es algo que todas las organizaciones públicas y privadas saben perfectamente. El CEO de Unilever, Paul Polman, buen conocedor de la realidad española, decía hace unas semanas en una conferencia en el IESE que si las redes sociales habían conseguido derrocar un gobierno en Egipto en una semana, con seguridad podrían... Read More
Más y mejor información
El Global
Cuando la Aemps inició su andadura tuvimos la sensación de que algo estaba cambiando para bien, y que lo hacía de forma serena pero diligente. También en esto la internacionalización ha ayudado; al igual que a todas las empresas y profesionales que han tenido la necesidad o el acierto de abrir su campo de actuación... Read More
Una nueva oportunidad
EL GLOBAL
Dejamos atrás un año particularmente difícil para el sector, que, desde luego, no nos ha dejado demasiados motivos para volver la vista atrás con añoranza. A los duros ajustes que han tenido que asumir industria y distribución, y a los retrasos en el pago a los proveedores por parte de las administraciones, se ha venido... Read More
Pharmacies may not engage in the wholesale of medicinal products
Royal Decree 782/2013, of 11 October, on the distribution of medicinal products for human use (Official Journal No 251/2013)
CAPSULAS Nº 148
Background On September 2011, the Health Authorities of Cantabria fined a pharmacy upon detecting that such pharmacy had sold medicinal products to a wholesaler on several occasions. The Cantabrian Health Authorities understood that the pharmacy committed a serious administrative infringement by carrying out these sales and, consequently, decided to impose a fine of 30.000 Euros.... Read More
The Department of Health regulates the Internet sale of medicinal products for human use that do not require medical prescription
Royal Decree 870/2013, of 8 of November, regulating the distance sale to general public, through Websites, of medicinal products for human use not subject to medical prescription
CAPSULAS Nº 148
Law 29/2006 limited the Internet sale to the medicinal products that were not subject to a medical prescription, as long as they were supplied by a pharmacy, with the intervention of a pharmacist, after such pharmacist has provided personalized advice and in accordance with the rules applicable to the medicinal products to be sold. The... Read More
The new regulatory framework for the distribution of medicinal product was finally approved
Royal Decree 782/2013, of 11 October, on distribution of medicinal product for human use (Official Journal No 251/2013)
CAPSULAS Nº 148
This new provision, which replaces Royal Decree 2259/1994, seeks to adapt the activity to the new times, regulating the concepts that have emerged in the market, and reinforcing the obligations of the operators regarding pharmacovigilance and fight against the counterfeit of medicinal products. Requirements for the practice of this activity The new regulatory framework will... Read More
Minority shareholder’s right to information: scope and limits to the request of “accounting documents, in a broad sense”
Judgment of the Plenary of the Supreme Court, Civil First Chamber, of 19 September 2013, on shareholder’s right to information
CAPSULAS Nº 148
A minority shareholder of a stock company, holding 25% of its shares, demanded, before the shareholders board was held, exhaustive information about the annual accounts that such company pretended to approve. The company did not offer all the information that he requested and therefore, after the rest of the shareholders approved the accounts, he decided... Read More
La guía de preparación merece una reflexión
EL GLOBAL
El origen de la guía se encuentra en el artículo 7 del Real Decreto-Ley 16/2012, aprobado en abril de 2012 al amparo del artículo 93 de la Constitución, que dice que “en caso de extraordinaria y urgente necesidad, el Gobierno podrá dictar disposiciones legislativas provisionales que tomarán la forma de decretos-leyes”. El mismo real decreto-ley... Read More