Import

Checklist for annual updates for parallel distribution: guidance for industry

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星期日, 六月 2, 2024
MSD, Update, Marketing, European Medicines Agency, Telephone, Agency, FMD, MSO, ABCD, Comment, Language, DD/MM/YYYY, Braille, Thumb, Single Supervisory Mechanism, European Commission, Economic union, Safety, MIA, Software, Reproduction, Annex, OMS, FAQ, Blue, Excipient, PDF, Parallel, Documentation, EXP, EMA, State, Pharmacovigilance, Import, MAH, 2D, Medical device

Checklist for annual updates for parallel distribution: guidance for industry

Key Points: 
    • 4
      Human Medicines Division

      Checklist for Annual Updates for Parallel Distribution
      Guidance for industry
      The European Medicines Agency (hereinafter 'the Agency') asks its applicants to use this checklist in
      advance of submission of an annual update for parallel distribution.

    • Upon receipt of an annual update for parallel distribution, the procedure manager proceeds to validate
      the documentation submitted in accordance with the checklist included below.
    • Please note that parallel distributors
      have six months to implement a new annex and three
      months for urgent safety updates.
    • Annexes to
      marketing
      authorisation

      Please note, that published yearly updates may not
      include the latest approved variation (i.e.

    • In those cases, please refer to the
      information published on the European public assessment
      report (EPAR), which should contain the latest approved
      variation.
    • Please download the annex in the correct
      language and determine the annex revision date from
      the naming convention of the downloaded PDF.
    • Checklist for Annual Updates for Parallel Distribution
      EMA/405782/2020

      Page 2/10

      Regulatory
      check

      Comments

      Yes N/A

      The highlighted date is the correct annex date that
      should be used for your submissions.

    • When the annual update includes multiple EU-numbers
      with different package leaflets for the same type of
      immediate packaging, please submit only one package
      leaflet.
    • A text comparison report mentioned in the submission
      form and included with an annual update will incur a
      reduced fee for the procedure.
    • the software should not change the file formats for

      Checklist for Annual Updates for Parallel Distribution
      EMA/405782/2020

      Page 3/10

      Regulatory
      check

      Comments

      Yes N/A

      the text comparison).

    • warning text or colour code per
      strength) as this has correct use and patient safely

      Checklist for Annual Updates for Parallel Distribution
      EMA/405782/2020

      Page 6/10

      Regulatory
      check

      Comments

      Yes N/A

      implications.

    • The prior notice letter is to be signed and sent either by
      the parallel distributor or by another company on behalf
      of the parallel distributor.
    • Checklist for Annual Updates for Parallel Distribution
      EMA/405782/2020

      Page 10/10

      Sample mockup of outer packaging - computer-readable text, i.e.

EudraVigilance - EVWEB user manual

Retrieved on: 
星期日, 三月 10, 2024
International Organization (journal), Level 2, Automation, Chapter Two, ACK, ISO, Classification, SSL, Sender, Clinical trial, Radio, Immediate, European, CAPS, European Medicines Agency, Report, MDN, ICH, Medicine, HTML, Internet, Medical dictionary, NCA, Originality, HTTPS, SHTTP, European Economic Area, Headquarters, NASK, Three-body problem, Privacy, Match, Database, Data entry, European Economic Community, MSSO, Module, ZIP, Acknowledgment, Acronym, Environment, Message, MLM, Access, Conference, Pharmacovigilance, XML, EMA, Gateway, Chapter One, MedDRA, Active ingredient, Communication, Validation, Public, Data analysis, Precision, RTF, Navigation, Salt, Security, Chapter Five, Contextual, International organization, Convention, SME, URL, Chapter Four, ID, MAH, Rich Text Format, Microsoft Edge, EudraVigilance, Name, MSK, UNK, Risk, Create, Tree view, ICSR, Chapter Three, Web browser, Commercial, R2, Socs, TAB, Literature, Courier, CIOMS, EV, Built-in self-test, Documentation, Coreidae, Council, S-HTTP, File Explorer, UI, Import, Calendar, WEB, Reproduction, Jousting, PDF, Economic union, Mobile phone
Key Points: 

    Manufacturing PMI® at 47.8%; February 2024 Manufacturing ISM® Report On Business®

    Retrieved on: 
    星期五, 三月 1, 2024
    Computer, Customer, Production, Import, Fiore, Allied Corporation, Forecasting, Plastic, Backlog, Appliance, Growth, Overalls, Weather, Transport, Electronic Products, Gross domestic product, GDP, USB On-The-Go, Component, CPSM, Heated tobacco product, Drink, Wood, Employment, Metal, Video game

    TEMPE, Ariz., March 1, 2024 /PRNewswire/ -- Economic activity in the manufacturing sector contracted in February for the 16th consecutive month following one month of "unchanged" status (a PMI® reading of 50 percent) and 28 months of growth prior to that, say the nation's supply executives in the latest Manufacturing ISM® Report On Business®.

    Key Points: 
    • (A Manufacturing PMI® above 42.5 percent, over a period of time, generally indicates an expansion of the overall economy.)
    • The Prices Index registered 52.5 percent, down 0.4 percentage point compared to the reading of 52.9 percent in January.
    • The Backlog of Orders Index registered 46.3 percent, 1.6 percentage points higher than the 44.7 percent recorded in January.
    • "The Supplier Deliveries Index figure of 50.1 percent is 1 percentage point higher than the 49.1 percent recorded in January.

    Shanghai GDP exceeds 4.72 trillion yuan in 2023

    Retrieved on: 
    星期二, 二月 6, 2024
    Internet, Investment, Album-equivalent unit, Growth, Import, Research, Software, GDP, Engineering, Information technology, Statistics, Renewable energy

    In 2023, Shanghai's total retail sales of consumer goods jumped by 12.6 percent over the previous year.

    Key Points: 
    • In 2023, Shanghai's total retail sales of consumer goods jumped by 12.6 percent over the previous year.
    • Shanghai's investment in fixed assets rose by 13.8 percent on a yearly basis in 2023.
    • The total transaction value of Shanghai's financial market reached 3,373.63 trillion yuan in 2023, up 15 percent from a year earlier.
    • Shanghai residents' disposable per capita income came at 84,834 yuan in 2023, showing a nominal annual increase of 6.6 percent.

    Gathering Global High-quality Products to Boost Industrial Upgrade -- "Shaping the future of food" FHC 2023 kicks off

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    星期四, 十一月 2, 2023
    United Kingdom, Exhibition, Export, Shanghai New International Expo Center, Food, Import, Commerce, News, Growth, FHC, European, Animal, Film industry, Tourism

    FHC covers an exhibition area of 170,000 square meters, with 30 national and regional exhibition pavilions and over 2,500 exhibitors.

    Key Points: 
    • FHC covers an exhibition area of 170,000 square meters, with 30 national and regional exhibition pavilions and over 2,500 exhibitors.
    • Mark your calendars for November 8-10, 2023, and get ready to embark on a gastronomic adventure like no other.
    • We can't wait to see you at the 26th FHC Shanghai Global Food Trade Show.
    • For inquiries, registration and more information, please visit our official website or contact our event organizers at: https://www.fhcchina.com/en/

    Gathering Global High-quality Products to Boost Industrial Upgrade -- "Shaping the future of food" FHC 2023 kicks off

    Retrieved on: 
    星期四, 十一月 2, 2023
    United Kingdom, Exhibition, Export, Shanghai New International Expo Center, Food, Import, Commerce, News, Growth, FHC, European, Animal, Film industry, Tourism

    FHC covers an exhibition area of 170,000 square meters, with 30 national and regional exhibition pavilions and over 2,500 exhibitors.

    Key Points: 
    • FHC covers an exhibition area of 170,000 square meters, with 30 national and regional exhibition pavilions and over 2,500 exhibitors.
    • Mark your calendars for November 8-10, 2023, and get ready to embark on a gastronomic adventure like no other.
    • We can't wait to see you at the 26th FHC Shanghai Global Food Trade Show.
    • For inquiries, registration and more information, please visit our official website or contact our event organizers at: https://www.fhcchina.com/en/

    Holley Focuses on Accelerating Growth with New Market Segment Orientation

    Retrieved on: 
    星期四, 十月 19, 2023
    Automotive Manufacturing, Manufacturing, Aftermarket, Automotive, Performance & Special Interest, NYSE, Import, News, UTV, Data management, Growth, Inc., Concordia University, JE, Legacy Classic Trucks, Management

    The strategic realignment establishes seven distinct market segments, further strengthening the company’s ability to serve the classic vehicle market while also expanding its focus on aftermarket solutions for newer model vehicles.

    Key Points: 
    • The strategic realignment establishes seven distinct market segments, further strengthening the company’s ability to serve the classic vehicle market while also expanding its focus on aftermarket solutions for newer model vehicles.
    • Each segment team will work closely with the company’s business units to develop a comprehensive portfolio of products for consumers in their respective segments.
    • As part of this new organization, Holley named Sean Crawford to the newly created role of Chief Product Officer.
    • Crawford joined Holley in March 2020 as Chief Marketing Officer and served in that role until this latest announcement.

    Philippines Apparel Textile Show & Philippines Sport Show and Asia International E-commerce Expo: Industry Event Generates New Momentum for Trade

    Retrieved on: 
    星期二, 十月 3, 2023
    Sports, Online Retail, Specialty, Consumer Electronics, Electronic Commerce, Technology, Other Sports, Fashion, Textiles, Retail, Footwear, Home Goods, Manufacturing, International, Exhibition, Clothing, SMX Convention Center Manila, Export, Import, Sport, Shoe, Commerce, Expo, Textile

    Philippines Apparel Textile Show & Philippines Sport Show and Asia International E-commerce Expo will be held from October 5 to 7, 2023 at SMX Convention Center in Manila, Philippines.

    Key Points: 
    • Philippines Apparel Textile Show & Philippines Sport Show and Asia International E-commerce Expo will be held from October 5 to 7, 2023 at SMX Convention Center in Manila, Philippines.
    • Nearly 100 Chinese enterprises will showcase their products in the fields of textiles and clothing, shoes, bags, sports and fitness equipment, etc.
    • Asia International E-commerce Expo, to be held simultaneously in the Philippines, will focus on hot-selling e-commerce products such as electronic products and household necessities.
    • Philippines Apparel Textile Show & Philippines Sport Show and Asia International E-commerce Expo will inject new vitality into the trade cooperation between China and the Philippines, generate new momentum for trade and create more business opportunities for both nations.

    Bravowhale Technology facilitate taicang local supply chain enterprises in achieving ESG compliance with international standards

    Retrieved on: 
    星期三, 九月 20, 2023
    Carbon, Communication, Electronic Products, RE100, International, International Liaison Department (Communist International), Speech, International Liaison Department, Policy, Clear, Information technology, SOC, Mechanical, Certification, Cloud computing, Internet, Climate change, Export, Machine, VCS, Import, ESG, Ecosystem, P&G, CCER, Chief information governance officer, Commerce, Medical device, Renewable energy, Electronics

    Bravowhale Technology collaborates with the Taicang Bureau of Industry and Information Technology, along with the I-REC Standard Foundation and the China Chamber of Commerce for Machinery and Electronics, to facilitate local supply chain enterprises in achieving ESG compliance with international standards

    Key Points: 
    • Bravowhale Technology collaborates with the Taicang Bureau of Industry and Information Technology, along with the I-REC Standard Foundation and the China Chamber of Commerce for Machinery and Electronics, to facilitate local supply chain enterprises in achieving ESG compliance with international standards
      HONG KONG, Sept 20, 2023 - (ACN Newswire) - Recently, the "'Carbon' Road Green Development Promotes Enterprises' Low-Carbon Transformation" exchange meeting co-sponsored by the Taicang Municipal Bureau of Industry and Information Technology and Shanghai Bravowhale Information Technology Co., Ltd. (hereinafter referred to as "Bravowhale Technology") served Taicang Enterprises The center was successfully held.
    • We look forward to strengthening communication and cooperation with Bravowhale Technology and further working with the I-REC Standards Foundation to promote mutual recognition of domestic and international standards and provide clear guidance for enterprises in our city.
    • ESG compliance ideas and directions, create a benchmark city for zero-carbon production for export enterprises, and help achieve the "double carbon" goal."
    • ESG compliance solutions that are flexible and meet international standards.

    Quintessential Nominated for Two Wine Enthusiast Wine Star Awards

    Retrieved on: 
    星期四, 九月 14, 2023
    Wine Enthusiast, Wine, Tourism, Communication, Import, New World, CERES, Quintessence, La Casona, Puntarenas, Demeter, Climate, Kreps, Douro (intermunicipal community)

    NAPA, Calif., Sept. 14, 2023 /PRNewswire/ -- Leading wine importer, marketer and sales company, Quintessential is honored to be nominated for two Wine Enthusiast Wine Star Awards for New World Winery of the Year and European Winery of the Year. Influential producers Matetic Vineyards, located in the Rosario Valley in Chile, and Quinta do Vallado, located in the Douro Valley in Portugal, are in the running for these titles respectively due to their storied histories and industry achievements. Managed by the Kreps family, Quintessential marks these accolades while celebrating 20 years of exclusively championing family-owned and operated wineries. Quintessential's global portfolio includes 30 dynamic families with 41 wineries in 11 countries.

    Key Points: 
    • NAPA, Calif., Sept. 14, 2023 /PRNewswire/ -- Leading wine importer, marketer and sales company, Quintessential is honored to be nominated for two Wine Enthusiast Wine Star Awards for New World Winery of the Year and European Winery of the Year.
    • Quintessential is nominated for two Wine Enthusiast Wine Star Awards 2023: New World and European Winery of the Year.
    • Steve Kreps Sr. shares, "Our relationship with Wine Enthusiast spans back to our early years as a company.
    • Vallado has secured 16 scores of 94+ from Wine Enthusiast in the last 5 years.