Joan Puig de Dou

The AEMPS has published the criteria for the approval of pack sizes in Spain. 💡 For nationally authorised medicinal products, the packs to be included in the SMPC and package leaflet should meet the criteria described by the AEMPS.   For medicinal products authorised by European procedures (mutual recognition, decentralised, centralised), as many formats as are approved at European level shall be included in the SMPC and package leaflet, together with the sentence "All pack sizes may not be available on the market". However, national codes will be assigned (at the request of the MAH) to packs that meet the criteria described by the AEMPS.  ✋ If you´d like some support with the national phase and obtention of national codes, just reach out to us!  #EIGNAPHARMA #AEMPS #EUREGULATORYAFFAIRS #EUPHARMAPACKAGING #EUPHARMA #REGULATORYAFFAIRS #EMA

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Dear all I strongly recommend to follow this appropriate, detailed and fundamental webinar on #toxicologic risk in #CMC organized by Azierta | QbD Group Spain and Grupo QBD

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Future directions in contractual mechanisms facilitating access to medicines The new regulations in the pharmaceutical sector significantly reshape the legal framework governing mechanisms that improve access to treatment. Alexandra-Silvia S. details the subject in an article that can be read by accessing the following link: https://lnkd.in/d5aVUXh7 #pharma #costvolume #protocolsforearlyaccess #freshperspectives #medicines #legislativeupdate #GNP #accesstomedicines

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The Spanish Agency for Medicines and Health Products (#AEMPS), dependent on the Ministry of #Health, has notified the International #Narcotics Control Board of a production forecast of 36 tons of medicinal #cannabis in 2024. Spain thus becomes the seventh producing country in the #pharmaceutical market for #therapeuticcannabis in the world, and although the procedures have been initiated to develop the Decree that approves the #medicalcannabis regulation, its consumption for this use has not yet been legalized 🌿 ⚗ 👉 https://lnkd.in/dJtaiBia Regarding research on therapeutic cannabis, the most studied #phytocannabinoids are #THC (or tetrahydrocannabinol) and #CBD (or #cannabidiol). The first produces relaxation, sedation, analgesia, antiemetic effects and stimulation of appetite (mainly by activation of CB1 receptors). On the other hand, CBD produces #analgesic or antiepileptic effects. Spain is occupying a preferential position in the production of therapeutic cannabis and this could be a great advantage if its #legalization were to occur when it comes to occupying a good position in the #pharmaceuticalcannabis market. #medicinalcannabis #pharmaceuticalindustry #pharma #pharmasector #cannabisproduction #pharmaceuticaltesting

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Discover best practices for meeting adequate particulate matter levels with Jorge Capurro, Director of Drug Delivery at Archimedic! One of the most important safety and performance endpoints for injectable combination products is to meet adequate particulate matter levels as specified in the USP and ISO standards, as applicable. Issues related to elevated particulate matter are sometimes found late in the development effort which can significantly impact timelines and budget; thus, leading to the cancelation of device development projects and even clinical trials. This presentation will examine a process that can be implemented to mitigate potential issues related to particulate matter prior to the significant investment in device development efforts. Insights will be provided on how to choose the appropriate delivery mechanism depending on drug product properties and best practices for choosing the right test method for measuring particulate counts. Archimedic is also an event sponsor at Combination Products Summit 2024, make sure to swing by their booth to say hello 👋 ! Register for Combination Products Summit: https://lnkd.in/eY8w4jNc #combinationproducts #usp #isostandards #particulatematter #drugproducts #drugdelivery #pharmaevent #conference

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Laboratory Materials Procurement: AEMPS - Agencia Española de Medicamentos y Productos Sanitarios Introduces Dynamic Acquisition System for Enhanced Efficiency The Spanish Agency of Medicines and Medical Devices (AEMPS - Agencia Española de Medicamentos y Productos Sanitarios) has introduced a dynamic acquisition system, SDA 1/2024, effective from May 29, 2024, to May 28, 2029, to streamline the procurement of laboratory materials and products for its control laboratories. This system, divided into reagents and contrast media, and consumable materials, allows continuous supplier engagement, enhancing operational efficiency and responsiveness. Suppliers can apply via the Public Sector Procurement Platform, ensuring a transparent and accessible process. AEMPS - Agencia Española de Medicamentos y Productos Sanitarios aims to maintain high-quality standards in its laboratories, supporting public health and safety, by periodically reviewing and renewing procurement processes to align with industry advancements. For more details please click the link! https://lnkd.in/dBQSnnxr #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

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The publication of the ISO/IEC 17025:2017 standard and its support in both the #ISO17034 standard and the #ISOGuide33 has meant the recognition of a systematic way of evaluating the competence of producers of #ReferenceMaterials and explaining rigorous definition of the difference between reference material and #CertifiedReferenceMaterial as a key element in ensuring #MetrologicalTraceability. #RM and #CRMs must be sufficiently homogeneous, stable and well-characterized for the intended use. The main differences between them are in the metrological traceability statement and in the determination of the property value and its associated uncertainties. Generally, a CRM involves the use of a primary method of measurement and RMs usually use a secondary one. At Cifga, we produce both types of materials. #CIFGA is a #CertifiedReferenceMaterials Producer accredited by Entidad Nacional de Acreditación - ENAC, specifically for producing Certified Reference Materials of #Biotoxins. This assures that CIFGA meets every requirement for competence in the particular field of Biotoxins Reference Material Production, including the distribution service. We are the first company in the world to be externally accredited for the production of certified reference materials for some #MarineBiotoxins. Many of our products are included in the technical annex of the hashtag #ISO17034 accreditation. #ISO17034 #MarineToxins #Toxins #Standards #Laboratory #ENAC https://lnkd.in/dT4ZG5vc

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For manufacturers of in vitro diagnostic #medicaldevices in the #EU. 🇪🇺 The European Commission’s Directorate-General for Health and Food Safety released a new notified body confirmation letter template. This template is vital for ensuring compliance with Reg EU 2024/1860 and contains key details including: ✅ Confirmation that the notified body (NB) has received a formal application in line with IVDR requirements. ✅ Verification that a written agreement has been signed with the manufacturer. ✅ Identification of devices under IVDR and the corresponding responsibilities for surveillance. The letter outlines critical timelines and conditions for devices transitioning from IVDD to IVDR compliance: • 31 Dec 2027: For devices covered by an IVDD certificate. • 31 Dec 2027-2029: For devices requiring NB involvement under IVDR. The template is a valuable resource for manufacturers and notified bodies. It provides a clear and concise way to communicate the status of an application or agreement, and to ensure that all parties are aware of their obligations under the regulation. You can download the template from the European Commissions website 👉 https://lnkd.in/dWR9J5dd Contact us if you need support to stay informed and ensure your processes align with the latest regulations ☞ [email protected] #MedicalDevices #HealthAndSafety #EURegulations #Compliance #NotifiedBodies #notifiedbody #RegEU2024/1860 #healthandsafety #medtech #medtechindustry #invitrodiagnostics #IVDR #MDR #IVDD 

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Meet our Business Development Managers, Dr. Nicolas HUGUET and Dr. Carles Callol, at Chemical Industry Regulations -CIR in Barcelona, Spain! to discuss how JRF Global can assist you with safety assessment studies for regulatory compliance. #JRF #CRO #SpecialityChemical #Chemistry #Synthesis #InSilico #InVivo #Toxicology #InVitro #ChemicalIndustryRegulations

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We are delighted to introduce newly joined member of the EBA – GM Pharma 🎉 👨‍🔬💊GM PHARMA is an international pharmaceutical company with medicines and food supplements manufactured in GMP-certified manufacturing plants in Western European countries (Germany, Greece, Spain, Switzerland, Italy, Sweden, Portugal, etc.) and in its own GMP-certified manufacturing plant in Georgia. 🔹GM PHARMA's solid oral dosage forms manufacturing site in Tbilisi, Georgia, is the largest pharmaceutical plant in the South Caucasus region. The basic formulation processes currently carried out in the factory are dispensing, blending, granulation, tableting, tablet coating, capsule filling, bottle filling and blister and bottle packaging, quality control. Tbilisi site is equipped with modern machinery and laboratory equipment made by the world’s leading companies: Gerteis, L.B. Bohle, Korsch, Fette, Uhlmann, Huttlin, Servolift, IMA, Erweka, Agilent, Waters, Stilmas, Milipore, etc. The company holds all national and international certificates, permits and licenses required for pharmaceutical manufacturing (Georgia National GMP Certificate, PIC/S International GMP Certificate, ISO 9001:2015, ISO 17025, etc.). 🔸GM PHARMA employs more than 600 professionals including those employed in its export countries. With >140 brands and >230 dosage forms in its portfolio, GM PHARMA holds one of the broadest product portfolio in the region covering almost all dosage forms and therapeutic areas, including a wide range of food supplements. 🔹More than 12 million patients are treated with GM PHARMA products in Georgia and the company's international, export markets every year, which shows the recognition of the company by consumers and healthcare specialists. Since 2017, GM PHARMA has been the market leader in the Georgian pharmaceutical market, in terms of both, sales value and sales units. GM PHARMA exports more than 100 products globally and has representative offices in 7 countries (Uzbekistan, Tajikistan, Kyrgyzstan, Armenia, Moldova, Azerbaijan and Kazakhstan), employing more than 250 employees expanding sales and being among the top five companies in several of these markets. 🔸GM PHARMA actively cooperates with European scientific and research centers and uses their experience in the production of its products. In cooperation with European scientific centers, GM PHARMA aims to produce novel generic drugs and innovative combinations of drug products in Georgia. 🔹GM PHARMA’s mission is to produce and supply healthcare products through a pioneering and innovative approach for the benefit of medicine and humanity by practicing all Quality and Safety norms and standards. 👉 EBA looks forward to a fruitful collaboration and is confident that GM Pharma will make significant contributions to our shared objectives. Wishing GM Pharma great success in all its future endeavors and in our joint efforts 🤝

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🔍 Exciting Update from AEMPS: New Safety Information for February! 🔍 📢 The Spanish Agency for Medicines and Health Products (AEMPS) has released crucial safety updates regarding medication use in Spain. These updates are essential for healthcare professionals and patients alike to ensure safe and effective treatment. 💊 Some key highlights from the bulletin include: - Risks associated with medications containing pseudoephedrine, valproate, mycophenolic acid, and more. - New recommendations for the use of certain medications in specific patient populations. - Important safety measures to prevent adverse reactions during medication use. 👩‍⚕️ Healthcare professionals are reminded of the importance of reporting suspected adverse reactions to help update drug safety information and minimize risks. 📝 For more details on the safety information and risk prevention materials, visit the AEMPS website or click the link below: https://lnkd.in/gc2rcYZF Stay informed, stay safe! 💙 #AEMPS #MedicationSafety #Healthcare #PatientCare #SafetyUpdates #Pharmacovigilance

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Congratulations to Biometría Aplicada, S.A. de C.V. - a #Catalyst on the #Targeted #Biometric #Solutions Beam in The #Biometric #Digital #Identity Financial Services Prism #Report! From the report .... “Biometria Aplicada is a #versatile #integrator of best-of-breed #biometric solutions with a customer-focused mandate and dedication to creative #innovation and problem solving. As #digital #transformation hits the #banking sector, the company finds itself bridging the gap between the traditional systems embedded in the #financial services industry and the bleeding edge of opportunity." For the full profile, download the report - https://lnkd.in/g_KMhqB8 #biometrics #digitalidentity #financialservices #fintech #marketanalysis #marketforcast #digitaltransformation #identitysolutions

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The recently published draft Royal Decree on #HTA in Spain outlines the establishment of a new “positioning group,” responsible for the preparation of key reports informing pricing and reimbursement decisions. These reports will replace the current therapeutic positioning reports developed by Spain’s drug regulator, AEMPS, and regional experts.  More specifically, clinical trial data and economic studies will be analysed by the new positioning group, that will ultimately make a recommendation on whether a drug should be reimbursed by the Interministerial Commission on Drug Prices (CIPM). Senior Health Ministry official César Hernández noted that the report preparation and pricing talks will be taking place in parallel, suggesting a more flexible system where price proposals from the manufacturer may be considered.  The regional perspective will be strongly represented in this new positioning group; 17 out of 27 members will represent each of the autonomous regions of Spain. This gives regional voices a more significant role compared to the CIPM, where regions currently only have a rotating presence in 3 out of the 11 votes. The impact that this is expected to have on P&R decisions remains unclear, however Hernández highlighted the value of considering regional perspectives in the HTA process.  While the Royal Decree on HTA has yet to be approved, Partners4Access will continue to monitor changes to the HTA landscape in Spain to understand how they may impact our clients’ current and future goals. For more information on how we can support your pricing, reimbursement, and market access (#PRMA) journey, please reach out. Written by Iro Malekou, Associate Consultant #P4AInsights #Spain #HTA #MarketAccess Sources:   1. https://lnkd.in/evKvHa9m

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The final day of EAPCCT 2024! Check www.eapcct2024.com for all the details. The European Association of Poison Centres and Clinical Toxicologists (EAPCCT) #acmt #aact #apamt #menatox

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📢 The EFPIA - European Federation of Pharmaceutical Industries and Associations has published an updated workflow for quality risk management of nitrosamines in hashtag hashtag #drugsubstances #drugproducts. Version 3.0 now available here: https://lnkd.in/gCgDvgjM Our experts can provide a strategic and structured risk-based approach for detecting and mitigating nitrosamine presence, including risk assessment and confirmatory testing. 📧 Contact us for support: [email protected] #nitrosamines #testingforlife #Eurofins #regulatatory

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Important Information for IVD Manufacturers: The Official Journal of the European Union (OJEU) announced two new harmonised standards! EN ISO 13408-1:2024 “Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)” and EN ISO 20916:2024 “In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)” were added to the list of harmonised standards. This makes 15 harmonised standards for IVDR. All harmonised standards: https://lnkd.in/eh9ptw6s #mdr #harmonisation #ojeu

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