We are thrilled to let you know that from March 19th 2018, we have become fully operational out of our new facilities! Same building, same floor, but expanded, more inspirational and better equipped to serve even better our present and future customers. You keep ON trusting us, we keep UP with our commitment to support you!

Fluoroquinolone and quinolone antibiotics

PRAC recommends restrictions on use of fluoroquinolone and quinolone antibiotics following a review of disabling and potentially long-lasting side effects. Once the CHMP has adopted the final opinion, the new restrictions will become applicable in all EU Member States. Keep an eye on https://bit.ly/2ysLFTQfor further information. #pharmacovigilance #PRAC #antibiotics

Monitoring of signals evaluated by the FDA

The list of safety signals being evaluated by the FDA has been published in its second Quarterly Report. We recommend monitoring worldwide signals as they might have an impact in your products in EU and ROW. We’ll be happy to include your products in our regular screening, we have an experienced team waiting for you.

Eignapharma: New EuDRAcon member

Eudracon, the leading network on regulatory affairs experts in Europe, has elected Eignapharma as its member representing Spain. Eignapharma is honoured with such appointment and is certain that this will only result in benefit of its customers and partners.

Biosimilars: Biogem & Eignapharma

Eignapharma announces that it has reached a collaboration agreement with Biogem (Molecular Biology and Genetics Institute). Biogem is specialised in lab scale development and production of biosimilars, monoclonal antibodies, new biological entities and related preclinical studies, either own promoted or contract projects assigned by industry stakeholders. Under this agreement Eignapharma will use its commercial efforts to put at the industry disposal Biogem’s research and development capabilities consisting on documented small-scale processes and fully protocolised technology transfers procedures to allow a safe scaleup to industrial production.

La AEMPS ha publicado la Orden Ministerial que inicia el procedimiento para el registro de los productos homeopáticos

Los titulares de productos homeopáticos dispondrán de un plazo de tres meses para comunicar a la AEMPS su intención de registrar sus productos como medicamento en base a la Orden Ministerial SSI/425/2018 de 27 de abril. Esta medida se lleva a cabo para adaptarse a la Directiva 2001/83/CE del Parlamento Europeo y del Consejo, de 6 de noviembre de 2001. Puedes consultar la Orden Ministerial aquí.

European Immunization Week (EIW) 23–29 April 2018

From 23 to 29 April 2018, the European Region celebrates European Immunization Week (EIW) to raise awareness of the importance of immunization for people’s health and well-being. For this purpose, the EMA has produced a video together with the community of patients, consumers, doctors, nurses and pharmacists across the EU, who took the time to explain why vaccination matters. #VaccinesWork #ImmunizeEurope #patientsafety

FEDRA receives an award from @asLAN association

FEDRA (the Spanish Agency database containing all notifications of adverse reactions produced by medicines) has been awarded by the association @asLAN in the category “Improvement in communication with the citizen”. Congratulations!

Q&A on Cosmetovigilance updated in the Spanish Agency website

AEMPS has updated its website section Q&A on Cosmetovigilance in order to better identify all the new regulations and indications applicable to consumers, distributors and healthcare professionals regarding the communication and transmission of undesirable adverse events. More info at AEMPS

EMA’s recommendations on ‘Dos and Don’ts’ for Eudravigilance users

The EMA has distributed some clarifying ‘Dos and Don’ts’ to be observed for ICSR reporting to Eudravigilance, based on additional operational experience with the system since November 2017. These simple but crucial indications will surely improve the quality of the system.

AEMPS: Recommendations for drug distributors regarding unusual sales and drug misuse

The Spanish Agency has released some recommendations in order to facilitate that drug distributors comply with specific obligations, related to the detection, investigation and notification of unusual sales patterns. This document concerns the need to put in place a specific procedure to communicate unusual sales that may constitute a diversion or misuse of medicines. More info at: https://bit.ly/2IXgEfi

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Location

Av. Ernest Lluch, 32-TecnoCampus
Tower TCM2 6th floor
08302 Mataró – Barcelona (Spain)

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+34 93 169 65 51
info@eignapharma.com