Freyr Solutions

Smarter the eCTD publishing software, smoother will be the eCTD submissions process. But to ensure the smoother submissions, life sciences organizations must consider the wide variety of documentation they need to manage.  The entire documentation Lifecycle covers a complete clinical and preclinical research data accumulated over the years. In addition, region-specific submission requirements (across the USA, the European Union, Canada, GCC, Saudi Arabia, Oman, South Africa, Switzerland, Australia, New Zealand, Bosnia & Herzegovina, and Thailand) vary depending on the respective Health authority (HA) regulations and, thus the submission templates and formats. Likewise, as organizations move towards fulfilling their submission obligations, either DMF or baseline submissions, under strict compliance timelines, they face increasing complexities to efficiently manage different eCTD templates / formats across the entire submission lifecycle. Some of the major challenges fac...

Freyr rDMS  is an end-to-end electronic Regulatory Document Management system exclusively designed to enable Regulatory Groups and Departments within a life sciences organization to seamlessly create, capture, manage, organize, connect, deliver and archive regulatory data and documents in a compliant, efficient and intuitive manner. While traditional Document Management Software Solutions are typically retrofit for regulatory needs, Freyr Regulatory Document Management Software is built ground-up, keeping specific nuances and expectations of regulatory strategies and operation functions in mind. Our solution combines an end-to-end set of features spanning the whole document lifecycle from inception and authoring up to submission and archiving of regulatory documents. With capabilities to efficiently handle enterprise-wide content and ease of integration with legacy systems, Freyr rDMS provides an integrated platform to address the critical need for knowledge sharing across th...

Freyr INSIGHT  is Freyr’s Regulatory Intelligence Enterprise Platform, which gathers and analyzes publicly available regulatory information. This includes communicating the worldwide reach of regulations, pharmaceutical updates using a system, and monitoring the current regulations, guidance, policy, and legislation. Regulatory Intelligence

Overview In an ever changing Regulatory environment, Regulatory authorities around the world mandate drug companies with various Drug labeling formats and standards. To comply with those time-critical labeling mandates, organizations find it challenging to create, track and manage various aspects of drug labeling lifecycle. Major challenges organizations face include: Management of various activities involved in the labeling process like review and approval work-flow Collaboration between global and regional teams Core to regional/national label alignment Change control and deviation management Quick and effective label changes based on new guidelines or drug updates Tracking and compliance At that time, ineffective tracking could result in high risk of mislabeling and counterfeit drugs leading to product recalls affecting overall finances of the organization. In such adversities, labelers look to implement a centralized label lifecycle management solution for structured ...

Overview Audit & Inspection readiness – The first and foremost aspect every pharma company / a CRO should consider is the Trial Master File (TMF) audit & inspection readiness. With stacks of essential electronic / paper-based clinical trial documents to be sourced, tracked and managed, the biggest setback companies could face is to allow reconstruction of the trial that confirms the quality of data produced. Therefore it is of paramount importance that these documents are filed, indexed, and archived in a way that they can be easily retrieved and available for inspectors to give insight about that trail. In addition to that, increasing complexity of clinical trials, procedural costs and redundancies with generation of essential documents may delay the approval of medicines to reach the market. This way, industry has come across a need for centralized eTMF solution which not only acts as centralized repository of all documents but also reduces costs includ...

Overview Beginning September 24, 2014 and going forward, all medical device manufacturers are required to meet the FDA mandated UDI compliance for their Class I, II and III devices, in phases. Source – GS1 Healthcare US ®  |  www.gs1us.org/healthcare The primary concern facing companies is how to navigate across some of the major challenges in the process of meeting the strict FDA timelines. Unidentified DI/ PI Sources & Data Configuration Inaccurate Document Version Control Error-prone Manual Data Submissions Non-existent Data Validation System Incompatible Publishing & Reporting Effectively handling large volumes of unstructured data from disparate and non-authenticated sources is one of the biggest challenges for manufacturers in meeting their UDI compliance obligations. Add to that the lack of version control measures, cumbersome manual submission, and inadequate data management process making the challenges far greater to handle. With the time...

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the  identification of medicinal products (IDMP) . These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Once implementation has been fully completed, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these standards. IDMP Compliance & Software The five ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616) simplify the exchange of information between regulatory authorities internationally and improve the safety monitoring of medicines by facilitating the assessment of data across classes of medicines and therapeutic areas. ISO finalized the IDMP standards in 2012 and is currently developing implementation guides at international level. Following the...

Overview In the current trend of contract manufacturing across the world, drug product manufacturing is getting stringent and competitive. The global health authorities are active and synchronized in setting-up new standards like never before to ensure drug product quality and patient safety. The quality guideline of ICH Q3D: Elemental impurities, is one such guideline that has been strategically prepared and is being implemented in phased manner across the ICH regions of EU, US, Japan and in Australia. All the new drugs in pipeline and all the authorized drug products are mandated to comply with the guideline by Dec, 2017. From 1 st  of Jan, 2018 the elemental impurities present in the drug products must be assessed throughout the ICH region as per ICH Q3D. With many products being manufactured, organizations may find it challenging to prepare and comply with this mammoth requirement. Elemental impurities usp Freyr supports its clients to prepare elemental impurity risk ...

With a booming economy and with both the domestic and multinational companies equally fulfilling the need of pharmaceutical and medical technology in the country, Brazil boasts a good fortune for foreign medicine and medical devices investors. For market entry, organizations should obtain market authorizations and product registrations from  ANVISA  (Agência Nacional de Vigilância Sanitária). However, the process involves significant Regulatory challenges right from the requirement of authorized representative to filings to approvals to time-bound license maintenance. Freyr Provides  Regulatory Services in Brazil Assisting foreign medicine and medical device investors enter the Brazilian landscape in a compliant manner, Freyr offers complete Regulatory support in the region. As a global Regulatory solutions and services partner, Freyr’s Regulatory services for Brazil span across: Medical devices Drugs Cosmetics Food & Dietary supplements OTC Biosimilars a...

Being one of the effective online Regulatory systems, Saudi Arabia stands an easy-to-go-with market for medical devices, medicinal products and cosmetics’ registrations and approvals. However, the GCC’s (Gulf Cooperation Council) increasingly complex Regulatory requirements emphasize the need for manufacturers to be abreast with the rapid changes. The challenge for foreign manufacturers who are willing to enter Saudi Arabia is to track and sustain the changes to register and obtain approvals for their medical devices or cosmetics in a cost-effective way. Freyr Provides  Regulatory Services in Saudi Freyr, being a global specialist Regulatory services provider, assists companies with the sustainable consulting for Regulatory affairs in Saudi Arabia. Freyr’s expert and dedicated regulatory teams enable clients with the end-to-end support for preparing and reviewing registration documents, manage  SFDA  submissions within regulated time-frames and thereafter obtaining ...

Ukraine offers a competitive advantage for medicinal products, medical devices and cosmetic manufacturers who are looking for Ukrainian business opportunities.  The product / Drug registrations in Ukraine are governed by The Ministry of Healthcare (MHC) of Ukraine and should be complied with number of regulations. Medicinal products or Medical devices may be imported only after obtaining the state registration wherein devices should obtain the National Mark of Conformity. Meanwhile manufacturers may have to face the challenge of appointing an authorized representative and navigating through the expanded list of documentation required and sample submissions to be followed. Freyr Provides  Regulatory Services in Ukraine To help foreign manufacturers streamline their Regulatory activities for Ukraine, Freyr, as a global partner, deploys the Regulatory expertise for end-to-end compliance in the shortest timeframes possible. Freyr can help clients to expedite the registration...

Clear-cut Regulatory guidelines coupled with constantly growing economy makes the United Arab Emirates (UAE) a favorable destination for foreign medicinal products & medical device manufacturers who are willing to enter the region. The Ministry of Health regulates the importation of medical devices and medicinal products. It can sometimes be difficult for foreign manufacturers to navigate through various Regulatory approvals required for importation which results in lengthy and complex procedural challenges. Freyr Provides  Regulatory services in UAE To address the manufacturer’s unique challenges for UAE market access, Freyr provides knowledge-based Regulatory affairs in the region. Freyr, as a preferred global Regulatory partner, provides end-to-end Regulatory Affairs services to assist foreign manufacturers to minimize the compliance related risks in effective timelines to enter the UAE market. Freyr is capable to expedite the registrations and market approval processe...

Being one of the advanced markets for Medical Devices enabled with high-tech functionalities and with majority of the population opting for high standard medicinal products, South Korea attracts Medical Devices, medicinal products and cosmetics manufacturers from all over the world. To access the market, manufacturers must obtain authorizations from the Korean Food and Drug Administration (KFDA). Though the market seems lucrative and provides enormous growth opportunities, the region’s increasingly strict regulations might challenge manufacturer’s compliance efforts for medical device registrations and cosmetics registrations. Freyr Provides  Regulatory services in South korea With the best of understanding on critical registration and licensing processes in South Korea, Freyr assists new market entrants, Device and Cosmetic manufacturers, to avail the maximum of opportunities by streamlining the processes enroute getting the Ministry of Food and Drug Safety (MFDS), formerly ...

Emphasizing the growth prospects of life sciences industry coupled with good number of foreign investments in pharmaceutical companies, Philippines offers credible growth opportunities for foreign medicinal and medical devices manufacturers. The FDA (Food and Drug Administration) Philippines, oversees the registrations and regulations in the region. Though the market boasts better monetary gains, the stringent Regulatory framework in the region might challenge manufacturers’ compliance efforts for healthy authority approvals and market authorizations. Freyr Provides  Regulatory services in Philippines As a specialized global Regulatory partner, Freyr assists manufacturers to get timely Regulatory updates of the region for successful navigation across complex market access procedures. Freyr’s Regulatory services for Philippines region span across: Medical Devices Cosmetics OTC Food Supplements

With new laws related to Regulatory requirements have come into force, Medicines, Medical Devices and Dietary Supplements manufactures who are willing to enter the Republic of Serbia, are advised to be more vigilant about the regulations and guidelines of  ALIMS  (Medicines and Medical Devices Agency of Serbia). Apart from the documents need to be submitted in the Serbian language, major challenges manufacturers might face is to compile, submit, and follow-up necessary regulatory requirements for local medicine / device registrations and approvals. Freyr Provides   Regulatory services in Serbia With the proven Regulatory Affairs (RA) and Quality Assurance (QA) experience in the Serbia, Freyr helps manufacturers to navigate the complex registration and approval procedural challenges. Having clear cut understanding of Serbian Regulatory procedures, Freyr can help foreign manufacturers with end-to-end RA consulting for: Medicines Medical Devices Dietary Supplements...

The increasing demands for quality healthcare and the rapidly emerging economic sector presents Vietnam as a beneficial market for foreign Drug or Device manufacturers. All medicinal products to be imported into the region requires approval from the Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV) while medical devices are regulated by the Department of Medical Equipment and Health Works (DMEHW). Communicating with different internal regulatory bodies might pose a challenge for foreign manufacturers who are new to Vietnamese Regulatory system. Freyr Provides  Regulatory services in Vietnam Freyr, as a global regulatory partner, assists foreign manufacturers in interpreting the Vietnamese regulations and advises them on Regulatory strategies to be implemented for the region for compliant market authorizations. With streamlined and quicker submission procedures, Freyr provides Regulatory consulting services in Vietnam for: Drugs Medical Devices Cosmetic...

The rapid economic growth coupled with domination of imported pharmaceuticals makes Cambodia a lucrative destination for foreign medicine and medical device manufacturers to invest in the region. The Ministry of Health, Cambodia and Department of Drugs and Food (DDF) oversees the drug regulations and registrations in the region. However, to navigate the Cambodian Regulatory regime manufacturers require expert Regulatory affairs for successful compliance and timely market authorizations. Freyr Provides  Regulatory services in Cambodia Freyr, providing end-to-end Regulatory Affairs consulting services in the region, assists foreign manufacturers navigate the Cambodian Regulatory landscape in a streamlined and compliant manner. Right from Regulatory roadmap to documentation to submissions, Freyr’s Regulatory services in Cambodia span across: Medical Devices Pharmaceuticals / Drugs Cosmetics Food & Dietary Supplements

With its central location, Tunisia stands as a gateway to Africa offering best business expansion opportunities for foreign medicine and medical device (MD) manufacturers. In addition to the rapidly developed private health care sector investments, Tunisia is leading the race to be the regional medical centre. To enter the region, manufacturers require to obtain the Authorization for Market Commercialization (AMC) from the Directorate of Pharmacy and Pharmaceuticals (DPM) of the Republic of Tunisia. With an obligation to require a local agent for necessary document submissions to DPM, foreign manufacturers might face a great challenge to navigate through the procedures. Freyr Provides  Regulatory services in Tunisia Freyr, as a specialist global Regulatory partner, assists foreign manufacturers in decoding the local regulatory requirements and proceed to mandatory Regulatory submissions for streamlined registrations and approvals. Freyr is capable to provide Regulatory servic...

Steadily growing economy along with the increasing demand for quality medicinal products and medical devices in Malaysia attracts foreign manufactures across the globe to invest in the region. To do so, manufacturers must get the market authorizations from the Ministry of Health. While the Drug Control Authority (DCA) oversees the pharmaceutical registrations in the region, the Malaysian Medical Devices Authority (MDA) regulates medical device registrations. Considering the rapid market expansion and radical regulatory transformations, Malaysian market access for foreign manufacturers would be anything but complicated and time consuming. Freyr Provides  Regulatory services in Malaysia With an updated Regulatory intelligence over the new Regulatory system of Malaysia, Freyr assists new market entrants to keep pace with the improved Regulatory requirements related to registrations, dossier compilation, submissions for necessary market authorizations. Freyr’s end-to-end Regulato...

Evolving Government healthcare initiatives and quick market expansion establishes positive signs for foreign medicinal product and medical device manufacturers to invest in the Kingdom of Morocco. Under the Ministry of Health (Ministère de la santé, MoH), the Moroccan government regulates the healthcare system inclusive of pharmaceuticals and medical devices. Though Morocco recognizes the certifications from the other reputed Health Authorities, which may ease out some of the Regulatory procedures for manufacturers, navigating through the local Regulatory reforms and activities might require an expert market know-how. Freyr Provides  Regulatory services in Morocco Leveraging uninterrupted Regulatory knowledge about the Moroccan Regulatory regime, Freyr assists manufacturers for timely registrations and market authorizations. Freyr is capable to provide Regulatory services in Morocco for: Medical Devices Drugs (NCE , Generics) Bio Tech (Bio similars, Vaccines) Oncology C...

Mexico stands a favorite destination for medicines and medical device manufacturers to explore the pharmaceutical market opportunities. To do so, manufacturers must obtain approvals from (Comisión Federal para la Protección contra Riesgos Sanitarios) COFEPRIS – The Federal Commission for Protection against Sanitary Risk. Enroute, foreign manufacturers might face challenges navigating the Mexican regulatory regime: Good Manufacturing Practices (GMP) and Pharmacovigilance, and other Regulatory requirements. Freyr Provides  Regulatory services in Mexico Freyr, exclusively focusing on the entire Regulatory value-chain in the region, assists manufacturers to be abreast with the Mexican Regulatory requirements and mandatory obligations. Freyr’s Regulatory services in Mexico span across: Medical Devices Drugs Cosmetics OTC Food & Dietary Supplements

With its significant socio-economic developments in recent years, and being well-known for technologically advanced pharmaceutical sector, Bangladesh offers deserved growth opportunities for foreign Medical Device / Medicinal product manufacturers who are willing to enter the region. Under the Ministry of Health & Welfare, Drug Control Committee (DCC), and the Director General of Drug Administration of Bangladesh ( DGDA ) supervises the drug regulations in the country. With the complex procedures need to be followed for the registrations, lack of comprehensive Regulatory knowledge would pose a great challenge for manufacturers to get market approvals. Freyr Provides  Regulatory services in Bangladesh Freyr, as a specialist Regulatory partner, assists foreign manufacturers to be abreast with the Bangladesh Regulatory regime and helps them navigate through complex procedures for successful market authorizations. Freyr’s end-to-end Regulatory services for Bangladesh span acr...

With steadily growing healthcare market, Indonesia offers excellent business opportunities for foreign medicinal products and medical device manufacturers. Under the authority of Indonesian Ministry of Health (MOH), the Indonesian National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – BPOM) oversees the regulations for medicines and medical devices in the region. To get the market access, manufacturers must navigate through the complex regulatory procedures that range from regulatory requirements, registration procedures and market authorizations. Freyr Provides  Regulatory services in Indonesia Freyr, as a global Regulatory partner, can assist manufacturers to navigate through the complex regulatory procedures that range from dossier compilation, regulatory submissions for obtaining market approvals in time. Freyr’s is capable to provide registration and approval assistance for: Medical devices Pharmaceuticals OTC Cosmetics Health Supplements

With Its rapidly growing economy, Nigeria has been a desirable emerging market for investors. With medical devices and pharmaceutical markets in Nigeria are expected to grow in coming years, foreign manufacturers shall consider quickly initiating their efforts for obtaining market access. Under the Nigerian Federal Ministry of Health, the National Agency for Food and Drugs Administration and Control (NAFDAC) and the Pharmaceutical Council of Nigeria oversees the drug and device regulations in the region. Though the market seems to be lucrative for imports, the regulations surrounded might pose a great challenge for manufacturers to navigate through. Freyr Provides  Regulatory services in Nigeria Having a complete understanding of the Nigerian healthcare market and NAFDAC regulations, Freyr assists manufacturers to address the Regulatory procedural challenges cost-effectively and in a timely manner. Freyr’s Regulatory services in Nigeria span across: Medical devices Pharmac...

Algeria has seen a steady growth in pharmaceutical investments attracting medicine’s and medical device’s investors from all over the world. The Directorate of Pharmacy and Medicine oversee the registrations and licensing management for market access. However, lack of regional Regulatory expertise might challenge foreign manufacturer’s compliance efforts in the region. Freyr Provides  Regulatory services in Algeria Freyr, as a global Regulatory partner, assists foreign manufacturers not only by providing comprehensive Regulatory affairs services, but also by offering time-critical Regulatory operations assistance. Freyr’s Regulatory services in Algeria span across: Medical Devices Pharmaceuticals / Drugs Cosmetics Food and Dietary supplements OTC Biotech Natural Medicines

With a comprehensive Regulatory framework, Japan stands a competitive market for foreign medicinal and medical devices manufacturers while investing in the region. Not only the stringent regulations inclusive of language barriers, but also the expensive Regulatory procedural challenges demand a special attention from manufacturers, who are willing to enter the region. To get the market access, manufacturers must comply with Japan’s Pharmaceutical and Medical Device Act (PMD Act), which is regulated by the Pharmaceutical and Medical Devices Agency (PMDA). Freyr Provides  Regulatory services in Japan Leveraging our cutting-edge knowledge on the Japan’s Regulatory Affairs, Freyr, as a specialized Regulatory partner, can assist foreign manufacturers to streamline their device approval process cost-effectively and in a timely manner. Freyr’s Regulatory services in Japan span across: Medical devices Cosmetics Biotech

With a rapidly growing economy and with the dominating scenario of foreign imports, the Republic of Yemen intend to attract many foreign medicinal products and medical device manufacturers to invest in the region. To obtain successful market entry, however, manufacturers need to get approvals from the Supreme Board of Drugs and Medical Appliances (SBDMA) and the Ministry of Public Health, agencies responsible for regulation of pharmacy practices, registrations and drug procurement. For sure, the pharmaceutical sector is growing in the region and the same with Regulatory procedural complexities as it involves communication with multiple entities. Freyr Provides  Regulatory services in Yemen As a specialized global Regulatory partner, Freyr offers localized Regulatory services to assist foreign manufacturers navigate the region’s Regulatory regime with ease. Freyr’s Regulatory affairs consulting services for Yemen span across: Medical Devices Drugs Food & Dietary Supple...

The growing number of foreign Pharma companies in Thailand coupled with the trend of regional harmonization forecasts a better business growth for the foreign imports of pharmaceutical products, devices, cosmetics, etc. Prior to importing or manufacturing in Thailand, manufacturers must obtain approval from the Food and Drug Administration of Thailand (Thai FDA). With the agency eyeing on the revised versions of regulations, anytime soon, foreign manufacturers might fall short of required Regulatory knowledge on new procedures necessary for market access. Freyr Provides  Regulatory services in Thailand Freyr, as a global Regulatory partner, assists manufacturers with expert Regulatory affairs in Thailand. To enable manufacturers, navigate through the Thai’s regulatory system cost-effectively and in shorter timeframes, Freyr provides Regulatory consulting services for: Medical devices Pharmaceutical Biologics Cosmetics Food & Dietary Supplements

Starting July 1, 2013, Croatia has become the official member of European Union (EU) with the Agency for Drugs and Medical Devices (HALMED) overseeing the Regulatory and compliance activities in the region pertaining to medicinal products and medical devices. Though the valuable efforts have been made to align the country’s registration requirements with that of the EU Directives, the fact that those have not yet been fully aligned might jolt the regulatory planning of new market entrants. Freyr Provides  Regulatory services in Croatia Freyr, being a specialist global Regulatory services provider, assists companies with the sustainable consulting for Regulatory affairs in Croatia. Freyr has the capability to act as a professional European Authorized Representative and can take ahead the Croatian medicinal product / medical device registration procedure for foreign / non-EU manufacturers.

With an improved fiscal performance, and with a universal health care system, Greece offers good investment opportunities for medicine and medical device manufacturers. Accessing the market requires manufacturers to obtain necessary approvals from The National Organization for Medicines, an entity of Ministry of Health and Social Solidarity. Right from informing the Greek National Organization for Medicines (EOF), manufacturers might have to cope with other complex Regulatory procedures for registrations and licensing. Freyr Provides  Regulatory services in Greece Freyr, as a Global Regulatory Solutions and Services provider, assists foreign manufacturers to be abreast with the Greece Regulatory regime for successful compliance and timely approvals as well. Freyr’s end-to-end Regulatory affairs consulting for Greece span across: Medical Devices Pharmaceuticals / Drugs Cosmetics Food Supplements OTC Biologics

To enter South Africa, foreign medicines and medical device manufacturers must comply with the regulations formed by the South African Medicines Control Council (MCC). However, with a recent legislation to form a new regulatory agency, the South African Health Products Regulatory Agency (SAHPRA) for regulating drugs, biologics, medical devices, in vitro diagnostics, and complementary medicinal products, food, and cosmetics might create some procedural challenges for manufacturers to go for registrations and obtain necessary approvals. Freyr Provides  Regulatory services in South africa Addressing the manufacturers growing concerns over the new Regulatory agency and required procedures for successful registrations and approvals, Freyr as an exclusive global Regulatory partner offers exclusive Regulatory affairs consulting services. Freyr’s Regulatory services in South Africa span across: Pharmaceuticals Medical Devices Biologics / Biotech Food and Dietary Supplements OTC...

Aiming at diversification of medicinal products and medical devices manufacturing base, Sri Lanka offers good business opportunities for Pharma, Biogen and Generic product manufacturers. For the market entry, however, the new entrants are obliged to obtain approvals from Cosmetics, Devices, & Drug Regulatory Authority (CDDA). Only drugs/devices registered and compliant with the authority standards can be manufactured, imported and marketed for sale in the region. Lack of updated Regulatory knowledge may sometime challenge or restrict manufacturers’ compliance efforts. Freyr Provides  Regulatory services in Sri lanka With an expert Regulatory affairs consulting team, Freyr assists manufacturers to decode the complex Regulatory requirements in the region and help them navigate the procedural challenges in time for successful market authorizations. Freyr’s Regulatory services in Sri Lanka span across: Pharmaceutical Cosmetics Veterinary

With massive improvements in healthcare systems and with rapidly growing economy, the Colombian medicinal drug or device market boasts a good deal of growth opportunities for manufacturers who are willing to enter the region. The National Food and Drug Surveillance Institute ( INVIMA ), the Colombian health regulatory agency, oversees the regulatory activities in the region. To go ahead, it is mandatory to have an authorized representative in the region for navigating through the complex structure of Regulatory submissions. Freyr Provides  Regulatory services in Colombia Freyr with extensive knowledge on regional / local regulatory requirements, assists foreign manufacturers to streamline the Regulatory submissions, thus to fast-track the registrations and approval processes. Freyr’s support for Colombian market span across: Pharmaceutical Drugs / Generics Medical Devices (Class I, IIA, and III) 90/385/ECC, 93/42/ECC and 98/79//EC Cosmetics – EU Regulation 1223/2009 and F...