Bring top talent to your organization with a compelling, informative recruitment presentation. Learn how Beautiful.ais webinar recap presentation template can act as a follow up for your audience to expand your reach after the webinar. Once a year, each team meets in different locations for a work-together. Weve traveled to Sweden, Italy, Spain, Colombia, and Georgia. EMA sends this (joint) Assessment Report to the Applicant making clear that it is sent for information only and does not yet represent the position of the CHMP, PRAC adopts PRAC RMP Assessment Overview and Advice for D180 LoOI. All major style guides, such as The Chicago Manual of Style[4] and the AP Stylebook,[5] have reflected this change. Design, prototype, and gather feedback all in one place with Figma. Access the ever-expanding Stories toolbox by tapping the smiley sticker-thing: Hootsuite makes it easy to schedule Instagram Stories in advance, including all the special tools and features you need. Leila Cruz. Our project plan template can help you and your team secure success in your next big endeavor. After submitting the form, youll receive the answer as a notification within Instagram in about a week. This Snapchat pitch deck shows how simple presentations can persuade investors into action with simple, clean design. When can I submit my similar biological medicinal product application considering the protection period of the reference medicinal product?). Information directly related to the patented indication can be deleted from sections 4.1. therapeutic indications, 4.2. posology and method administration and 5.1. pharmacodynamic properties of the summary of product characteristics. . The number of websites continued growing to over 1 billion by March 2016 and has continued growing since. We conducted an experiment that found a significant correlation between posting a Reel and an immediate boost in overall engagement rate. Set your new team members on the right path with our new hire onboarding template. Web browser plug-ins were then used to add audio, video, and interactivity (such as for a rich Web application that mirrors the complexity of a desktop application like a word processor). Static sites serve or capture information but do not allow engagement with the audience or users directly. Most dating sites in the 2010s have the functionality of. These may include games and. Your submission has been received! Each of your data sources will have specific metrics you need to track. Marketing authorisation holders must in all cases comply with the requirements of Community legislation. The appropriate type IB variation should be submitted to align the product information of the similar biological medicinal product with the product information of the reference medicinal product, following expiry of the patent. [2021]", Internet Corporation For Assigned Names and Numbers (ICANN), Websites with country access restrictions, https://en.wikipedia.org/w/index.php?title=Website&oldid=1126002858, Wikipedia indefinitely semi-protected pages, Creative Commons Attribution-ShareAlike License 3.0. Google Ads and Bing Ads also offer the Broad Match Modifier type (although Google retired it in July 2021) which differs from broad match in that the keyword must contain the actual keyword terms in any order and doesn't include relevant variations of the terms. In this Guideline, MAHs are also asked to propose to the EMA/CHMP, at the time of preparation of a DHPC, a plan for communication to patients and the general public for subsequent implementation. As a scientific matter, the type of bridging data needed will always include data from analytical studies (e.g., structural and functional data) that compare all three products (the proposed biosimilar, the EEA-authorised reference product and the non EEA-authorised comparator), and may also include data from clinical PK and/or PD bridging studies for all three products. In the heart of this dashboard lie conversions, both for individual campaigns and aggregated, but you can also see the device breakdown and spending budget. All bids for the keyword that target the searcher's Geo-location, the day and time of the search, etc. Specific requirements that such applications should fulfil are listed below: This summary should include details on the similar biological medicinal product, its active substance, raw materials and manufacturing process. Surprisingly, also the average session on Pornhub (14 minutes). [17] Today, companies such as adMarketplace, ValueClick and adknowledge offer PPC services, as an alternative to AdWords and AdCenter. You can customize the targeting options or have Instagram automatically target your ads. An USR is an urgent regulatory action, which is triggered by a MAH of a centrally authorised product or the European Commission in the event of, or to prevent risk to public health associated with the use of this medicinal product. Use this template Details. In 2020, Facebook, a social networking site founded by Mark Zuckerberg recorded over 2.7 billion monthly active users. Share & print Washington, D.C. Today, the Consumer Financial Protection Bureau (CFPB) issued guidance about two junk fee practices that are likely unfair and unlawful under existing law. Learn how Beautiful.ais competitor analysis report template can help you define where your SEO efforts are winning and where theyre falling short. Assign conversations to team members, track responses, and ensure no one falls through the cracks. Clicks are a way to measure attention and interest. Keep it all organized with a software integration template. Learn how Beautiful.ais 30-60-90 template can help you plan a new employee's first 3 months onboard. Comparability is conceived as a step-wise process that is tailor-made for each product. Seize opportunities by showcasing your product idea in our product proposal template. By analogy to the placing on the market, the cessation of placing on the market or marketing cessation is A website (also written as a Web site) is a collection of Web pages and related content that is identified by a common domain name and published on at least one Web server.Examples of notable websites are Google, Facebook, Amazon, and Wikipedia.. All publicly accessible websites collectively constitute the World Wide Web.There are also private websites that can Free expertly crafted files you can duplicate, remix, and use. As with other forms of advertising, targeting is key, and factors that often play into PPC campaigns include the target's interest (often defined by a search term they have entered into a search engine or the content of a page that they are browsing), intent (e.g., to purchase or not), location (for geo targeting), device used (e.g. Max 12min read. Most websites fit in this category to some extent. Our hiring process involves less manual work. Learn how Beautiful.ais social media audit template can help you take inventory of your social media accounts and analyze whats working. This means that for a reference medicinal product, the start of the data exclusivity and market protection periods is determined by the first MA in the Union which was granted in accordance with the relevant European pharmaceutical legislation (Acquis Communitaire). LinkedIn is the world's largest professional network with over 800 million members in more than 200 countries and territories worldwide. Its easy to sign up from scratch. Marketing All you need to know about building a brand. (2011). We recreated it in Beautiful.ai. Dont worry, we have a free social media audit template to help out. This is effected under Palestinian ownership and in accordance with the best European and international standards. ICH countries). questions and answers documents regarding marketing and cessation notification, Article 13(4) of Regulation (EC) No 726/2004, Article 14(4-6) of Regulation (EC) No 726/2004, Questions and answers on the notification to the EMA of actual marketing and cessation of placing on the market for centrally authorised medicinal products (EMEA/180078/2005), Questions and answers on the application of the so-called 'sunset clause' to centrally authorised medicinal products (EMEA/180079/2005), Q&As for patients: Biosimilar medicines explained, Send a question to the European Medicines Agency, a significant therapeutic, scientific or technical innovation, or, the granting of a Union authorisation for the, a new technology or a new application of technology is used for the development or the manufacture of the, For the scientific evaluation of a similar biological. The Balanced Scorecard. EMA circulates draft translations to Member States for review, Applicant provides EMA with final translations of SmPC, Annex II, labelling and package leaflet in all EU languages (including Icelandic and Norwegian), taking account comments received from Member States by +19 Days after adoption of the Opinion, Transmission of Opinion and Annexes in all EU languages to Applicant, Commission, and members of the Standing Committee, and Norway and Iceland. However, due to the particularities of the similar biological medicinal product applications (e.g. This approach is reflected in the revised [3] For example, in the year 2014, PPC(Adwords) or online advertising attributed approximately US$45 billion of the total US$66 billion of Google's annual revenue[18] In 2010, Yahoo and Microsoft launched their combined effort against Google, and Microsoft's Bing began to be the search engine that Yahoo used to provide its search results. Browse all templates. There are also private websites that can only be accessed on a private network, such as a company's internal website for its employees. Immediately following the finalisation of the USR for the similar biological medicinal product, the Agency will inform the MAH that the changes may be introduced and that a subsequent type IB/II safety variation should be submitted without any delay (no later than 15 days after the finalisation of the USR). 18 tips for a winning Instagram marketing strategy, tag products in your scheduled Hootsuite posts, Instagram Reels in 2023: A Simple Guide for Businesses, Instagram Reels Algorithm: Everything You Need to Know, Instagram Reels Tutorial: 10 Editing Tips You Should Know, 15 Unique Instagram Reels Ideas for Your Business, How to Create a Social Media Marketing Strategy in 9 Easy Steps (Free Template), How to Use Instagram Carousels to 10x Engagement [Guide], How to Sell on Instagram in 2023: 8 Essential Steps, 20 Instagram Post Ideas to Boost Engagement, Organic content: Photo, video, or carousel posts, Reels, Stories, Paid content: Instagram ads, including Stories ads, Shopping ads, and more, Shopping tools: Shop tab, Product tags and catalog, Live shopping, Instagram Checkout, Shopping ads, Checkout directly inside Facebook and/or Instagram. Used to preserve valuable electronic content threatened with extinction. Used to provide background information about a business, organization, or service. Lets glimpse at the KPIs that make this integral dashboard tick. Users can comment on these posts, and these comments may also be ranked. Figma connects everyone in the design process so teams can deliver better products,faster. Scheduled. Head of Sales at hot tech startup Notion uses this winning sales deck to close deals. a site on which teachers, students, or administrators can post information about current events at or involving their school. In order to maximize success and achieve scale, automated bid management systems can be deployed. Moreover, by gaining the ability to compare digestible visual data, you can spot trends, capitalize on strengths, identify weaknesses, and improve the success of your projects significantly. Easily create, analyze, and schedule Instagram posts, Stories, and Reels with Hootsuite. Influencer marketing is still going strong in 2023 and projected to grow more every year. Thats 29.9% of all internet users and 23.9% of everyone over age 13 worldwide. Yes, it also boosts your engagement rate. As mentioned earlier, choosing the right KPIs as well as customizing the design and the position of each element will prove to be an efficient way to present your project and the performance of the same. 1. 2022 Hootsuite Inc. All Rights Reserved. SMEs spend $108,000 to $120,000 annually on PPC ads. Articles 59(3) and 61(1) of Directive 2001/83/EC require that the package leaflet reflects the results of consultation with target patient groups ('user consultation') to ensure that it is legible, clear and easy to use and that the results of the assessment carried out in cooperation with target patient groups are provided to the competent authority. JavaScript is also built into most modern web browsers, and allows for website creators to send code to the web browser that instructs it how to interactively modify page content and communicate with the web server if needed. Raising money from investors for your startup is challenging at any stage and requires a great pitch deck. Learn how Beautiful.ais OKR template can help leadership set goals and expectations to improve team processes. And this is the essence of what is a project dashboard time and money saved. Many websites do aim to make money using one or more business models, including: There are many varieties of websites, each specializing in a particular type of content or use, and they may be arbitrarily classified in any number of ways. Heres how Instagram marketing can help you grow your business. Give away free products in a simple raffle by having users like and comment on your post, or partner with someone else in your industry to split the cost of a larger prize package. 10 Free Project Roadmap Templates to Plan Out 2023 . However, in many cases, advertisers can negotiate lower rates, especially when committing to a long-term or high-value contract. If you decide on a marketing project with Google Ads (formerly known as AdWords), you need a clear overview of the stats, metrics, budgets, and overall campaign performance. Keep things light with jokes, or stick to the facts? Have some. Heres a grant proposal presentation example to help impress potential investors and raise funds for your next project. Dont use one of those? Eager to learn while you wait? A high quality profile photo (a headshot or logo). Build an iterative design flow with live collaboration that keeps you in the loop whether youre working in the office or remotely. Similar biological medicinal products are approved under the same standards of quality, safety and efficacy as any other medicinal product. Nobelium. Beautiful.ai gave the design a much-needed makeover. [1][2] On 30 April 1993, CERN announced that the World Wide Web would be free to use for anyone, contributing to the immense growth of the Web. Brands using Shopping features must adhere to Metas merchant policies. All the other requirements of Module 1 apply also to similar biological medicinal products with the exception of the paediatric requirements set out in Articles 7 and 8 of the Paediatric Regulation. But this intuitive data-driven software is only effective if it has the right attributes, qualities, and functionality for the job. HTML 5 includes provisions for audio and video without plugins. The important notion here is not to overburden the dashboard with information that's not relevant, too many colors, or metrics that wouldn't even fit into your story. The auction plays out in an automated fashion every time a visitor triggers the ad spot. So how can you use Instagram marketing to grow your business in 2023? If you feel like creating your own contract from scratch, consider the key elements that famous photographers recommend including in it:. Cost-per-click (CPC) is calculated by dividing the advertising cost by the number of clicks generated by an advertisement. We can design faster with real content, and everyone has visibility into design projects., Using Figma prototypes for usability testing, we are able to run tests, iterate quickly, and keep moving forward., With Figma, its easier to maintain our design system. after 30 October 2005 for national, decentralised and mutual recognition procedures and as of 20 November 2005, for the Centralised Procedure. Learn how to sell on Instagram. This period of 8 years from initial authorisation of the reference medicinal product, providing a period of so-called 'data exclusivity', applies only for reference medicinal products for which the marketing authorisation application has been submitted as of 30 October 2005 for MRP, DCP and national procedures and as of 20 November 2005 for Centralised Procedure according to the revised European Union legislation. This Foursquare pitch deck shows how simple presentations can persuade investors into action with simple, clean design. A simple connection to the Internet is all you need and you can access your project management software dashboard with just a few clicks. What is the so-called 'reference medicinal product' referred to in the application for a similar biological medicinal product?). Here are a few strategic planning models you can use to get started. Dynamic HTML uses JavaScript code to instruct the Web browser how to interactively modify the page contents. Oops! A site where people can ask questions and get answers. She's known for quickly understanding and distilling complicated technical topics into conversational copy that gets results. A project management dashboard is a data-driven platform that displays metrics, stats, and insights that are specific to a particular project or strategy by presenting a tailored mix of KPIs in one central location in order to benefit the project's performance. A site the business of which is the creation and distribution of original content. Having the results side-by-side with our Figma files is a great plus., Figmas brought rapid collaboration to our teams. Very large websites, such as Facebook, Yahoo!, Microsoft, and Google employ many servers and load balancing equipment such as Cisco Content Services Switches to distribute visitor loads over multiple computers at multiple locations. The bridging report should be included in Module 1.3.4 of the dossier. Project dashboards present and visualize the data thats 100% relevant to a particular project, and as every insight is available in one central location, its possible to gain swift access to all of the insights or metrics that are integral to your project without logging into other applications or platforms. Pay-per-click is usually associated with first-tier search engines (such as Google Ads, Amazon Advertising, and Microsoft Advertising formerly Bing Ads). Notion Marketing Templates. These tools generally allow for bid management at scale, with thousands or even millions of PPC bids controlled by a highly automated system. Moreover, it showcases all of the insights you need to decide where to place your marketing budget in the most informed, strategic way possible so that you can present your results to your clients quickly and efficiently. You dont need to fill out the rest of your profile right now (more on how to optimize it later). By explaining the benefits of creating a PM dashboard, you will know why these data-driven dashboards are essential for modern management efforts. Many bloggers use blogs like an editorial section of a newspaper to express their ideas on anything ranging from politics to religion to video games to parenting, along with anything in between. Click Next on the following page to start the manual set up process. Theres a lot to cover here, so check out our full step-by-step recommendations to optimize your Instagram profile. The reference medicinal product is a medicinal product which has been granted a marketing authorisation by a Member State or by the Commission on the basis of a complete dossier, i.e. We cover tips for getting that supporting content in our complete guide to getting verified on Instagram. Leave up always-relevant ones like FAQ or ordering information. Theyll recognize your style. Next, we see a gauge chart that provides an overview of the tasks by status, next to a table breaking down tasks in more detail. Lastly, choose if you want your ad to appear only on Facebook, Instagram, or Messenger, or across all three platforms. Are you casual and fun, or serious and scientific? Pay-per-click (PPC) is an internet advertising model used to drive traffic to websites, in which an advertiser pays a publisher (typically a search engine, website owner, or a network of websites) when the ad is clicked.[1][2]. Use these modern go-tos easily and often. Test out different ad copy and calls to action. Make an impression by putting together an impactful presentation with this template. (Please refer to 'Will my similar biological medicinal product be considered interchangeable with the reference medicinal product?'). For a similar biological medicinal product, when the medicinal product is not placed on the market as of the granting of the marketing authorisation, the 3-year period without marketing will start counting, for the purpose of the sunset clause monitoring, from the date of notification of the marketing authorisation to the MAH. Creating your social media marketing strategy doesnt need to be painful. Showing 0 results of 0 items. Plus, if I had friends a team, everyone could collaborate in the same Notion workspace, too. All publicly accessible websites collectively constitute the World Wide Web. Cover everything new employees need to know from day one and beyond. But how do you put a number on it? Remember: its whats inside that counts (most). Want to learn more about perfecting your ad targeting? Targeting is critical to your ads success. A dynamic website is one that changes or customizes itself frequently and automatically. In many cases, the publisher has a rate card that lists the pay-per-click (PPC) within different areas of their website or network. Evaluate your performance often and set aside time to run experiments to see which tactics work best for you. SEO and Marketing. Coffee-Themed Journal In line with the revised rules mentioned above, applications for similar biological medicinal products can be submitted after expiry of the data exclusivity period for the reference medicinal product i.e. Its one of the best company overview PPT templates for an agency profile presentation. Within the EU regulatory framework, the primary objective in evaluating an Article 10(4) application is to determine the similarity (or not) of a given biological medicinal product to a reference medicinal product. . for the keyword Beatles. Freelancers. Learn how Beautiful.ais rebrand presentation can help your team introduce your new brand image to key stakeholders. with other users. Trusted by employees at 800+ of the Fortune 1000, We could have SWORN you were someone who wanted to grow on social media and beat your competitors. 10 IT & Technology Buzzwords You Wont Be Able To Avoid In 2023, Top 10 Analytics And Business Intelligence Trends For 2023, Why Data Driven Decision Making is Your Path To Business Success. was up for renewal in July 2003, Yahoo! Build better products as a team. Starting an employee advocacy program can boost your profits 23% and internal team morale. Talent Agency CRM Template. Examples of notable websites are Google, Facebook, Amazon, and Wikipedia. What is the legal basis for my application? and Question 4. Industry-leading courses and certifications to advance your skills. Preparing for your next board meeting? Click Promote Now to save and launch your Instagram ad campaign. This may include information about a company and its products and services through text, photos, animations, audio/video, and navigation menus. For safety issues, including those related to quality aspects, requiring only a change of the SmPC and not the PL and/or Labelling, the revised Product Information will be disseminated mainly by means of the DHPC. If you are someone who has no notion on how journals work, have never kept track of the things you do in a way journals are useful for and have a good sense of humor, maybe you can start off with a funny journal. For centrally authorised similar biological medicinal products of nationally authorised innovator products the EMA will provide the MAH of the similar biological medicinal product, upon notification by the respective competent authority, with the exact wording to be implemented and will request the MAH to submit a variation as soon as possible or at the latest within 2 months to implement the changes in the PI as adopted for the innovator. Reopened tickets will show you how effectively a specific task is handled, saved correctly, and don't get reopened later. If the Applicant wishes to omit other information than the one mentioned above directly related to the patented indication, this must be properly justified. In short, any project dashboard worth its salt will allow all departments to work with the data thats most important to their role in a particular project, without fuss. For now, we will look at the top examples from various functions and provide you with details on each. Hootsuite also offers detailed analytics comprehensive reporting, as well as a calendar view and content creation tools that allow you to publish the best content possible. Use a competitive analysis report template to evaluate and analyze your competitors strengths and weaknesses. Simple reference to fees payable can be found in thePre-authorisation guidance. A marketing agency can decide to allocate its budget differently after the team has seen that the most traffic comes from a different source of the invested budget. That way you can prevent issues within the projected launch data and adjust your tickets accordingly. Not every shot will be an Ansel Adams-worthy one, but you cant beat the authenticity of real customer photos and stories. When submitting this request, the applicant should use the While an online reporting tool provides you with many different angles from which you can monitor your projects, the important point to stress is the possibility to use real-time data. You can add up to 30 hashtags per Instagram post. The eligibility request should also be submitted for duplicate similar biological marketing authorisations. Without effective, target-driven marketing strategies, your business would never grow or evolve. CHMP discussion and decision on the need for adoption of a list of Outstanding Issues and/or an Oral Explanation by the Applicant. Similar to handing out a printed brochure to customers or clients, a static website will generally provide consistent, standard information for an extended period of time. The reference medicinal product should have been authorised under Article 6 of Directive 2001/83/EC for not less than 8 years in a Member State or in the Union. [11] An estimated 85 percent of all websites are inactive.[12]. We get a total of the hours worked divided into billable and non-billable, hours worked on each task and a detailed breakdown of hours of the last 8 months. This involves a comprehensive head-to-head comparison of the biosimilar and the reference medicine. Students. Some websites are informational or produced by enthusiasts or for personal use or entertainment. 61% of Gen Zers and Millennials prefer videos under 1 minute long. Not only that, but 500 million people use Stories every day. Measuring your ROI, or return on investment, is important for reporting to your boss, but it can also help you justify establishing or increasing your paid advertising budget. 44% of Instagram users shop weekly on the platform, and 1 in 2 use Instagram to find new brands. MAHs are advised to inform the EMA, within 60 days from the granting of the marketing authorisation, of the existence and if known, the expiry dates of the other protection period(s) to be respected as appropriate. For further information on user consultation, including methods of user consultation and submission and assessment of information on user consultation, please refer to thePre-authorisation guidance. Explore templates for marketing, sales, pitch decks, education, and more. However, in practice, the success of such a development approach will depend on the ability to characterise the product and therefore to demonstrate the similar nature of the concerned products. Over time, those conversations become the foundation of their perception of your brand and greatly influence purchase decisions. This complements the Agency's pre-authorisation guidance. With Hootsuite, you can schedule posts for Instagram (Posts, Stories, and Reels), Facebook, TikTok, Twitter, LinkedIn, YouTube, and Pinterest. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I of Directive 2001/83/EC and the related detailed guidelines. Here's how to make carousel posts part of your Instagram strategy. In addition to digestibility (or scannability, as its sometimes referred to), its essential for project management dashboards to be completely user-friendly. Similar to an information site, but dedicated to dispensing news, politics, and commentary. Platform to fund projects by the pre-purchase of products or by asking audience members to make a donation. If youre unsure where to start, check out our Series A presentation template and get a head start in just a few clicks. Agoda Business PowerPoint template (30 Slides) marketing kit, or other purposes. Server-side dynamic pages are generated "on the fly" by computer code that produces the HTML (CSS are responsible for appearance and thus, are static files). Pinpoint the best marketing segments for your brand and qualify leads with our streamlined customer profile template. Select Business as the account type and follow the prompts to convert your account. Whether youre looking to fund your own small business, or looking to raise money from investors, this business plan template will give you a headstart. Productivity 34 Team Building Activities for Your Team in 2022 . Theres a lot of moving parts involved in software integration. A mood board presentation is a compilation of images and words to represent ideas for a project or business. A Next.js site using new SSG support with a Notion backed blog. However, websites can offer PPC ads. The process is different for each, so check out Metas list of supported platforms to find instructions for yours. Once your project is done you can analyze the data and see what could've been done differently or better and prepare strategies for your next projects. For example, this is what the next step is for the Build your business goal. a non-EEA authorised version of the reference medicinal product) which will need to be authorised by a regulatory authority with similar scientific and regulatory standards as EMA (e.g. Such advertisements are called sponsored links or sponsored ads, and appear adjacent to, above, or beneath organic results on search engine results pages (SERP), or anywhere a web developer chooses on a content site. With the application for the safety variation, the MAH should indicate in the application form the timeframe for implementation of the safety variation. In the app, open the menu. For similar biological medicinal products, also known as 'Biosimilars', eligibility can be granted to the Centralised Procedure as follows: 1.2.1 Mandatory scope of the centralised procedure. Applicants should also consider the scientific guidelines EMA has published to help developers of biosimilar medicines conform to the strict regulatory requirements for approving biosimilars. But first, we will answer the basic question: what is a project dashboard? and send it electronically, to: cpeligibility@ema.europa.eu, accompanied by the draft SmPC and a justification for eligibility, being the later especially required for medicinal products falling under the optional scope of Article 3(2)b. Article 11 of Directive 2001/83/EC and Article 3.3(b) of Regulation No 726/2004 allow Applicants/Marketing Authorisation Holders to exclude from their proposed product information those parts of the SmPC of the reference medicinal product referring to indications or dosage forms still covered by patent law. There isnt a wrong way, but you need to stay consistent. In response, the content of the Web page will spontaneously change the way it looked before, and will then display a list of Beatles products like CDs, DVDs, and books. By gaining a panoramic view of these insights, its possible to make your companys IT projects more time-efficient, cost-effective, and results-driven than ever before. See: EMA pre-submission guidance for users of the centralised procedure - List of questions. Steps prior to submitting the application, Tailored scientific advice to support step-by-step development of new biosimilars, rules governing medicinal products in the European Union, volume 2, notice to applicants, The rules governing medicinal products in the European Community, notice to applicants, Volume 2A, Chapter 1, Guideline on similar biological medicinal products CHMP/437/04 Rev1, pre-submission request form (eligibility), see pre-submission guidance on letter of intention and documentation, guideline on similar biological medicinal products (CHMP/437/04 Rev 1), Notice to applicants, volume 2A, chapter 1, Notice to applicants, volume 2B, module 1: Application form, Guideline on Similar Biological Medicinal Products CHMP/437/04 Rev1, The rules governing medicinal products in the European Union notice to applicants, Volume 2A, Chapter 1, Procedural advice on CHMP/CAT Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62(1) of Regulation (EC) No 726/2004 (EMA/151751/2010), CHMP rules of procedure (EMEA/CHMP/111481/2004, EMA policy on the handling of conflict of Interests for EMA Scientific Committees Members and Experts, Chapter 1 (section 6), The Rules governing Medicinal Products in the European Union, notice to applicants, Volume 2A, Union register of medicinal products for human use, explanatory note on fees payable to the European Medicine Agency, Fees payable to the European Medicines Agency, Handling of duplicate marketing authorisation applications, Guideline on the procedure for accelerated assessment pursuant to article 14 (9) of Regulation (EC) No 726/2004, The rules governing medicinal products in the European Union, notice to applicants, Volume 2A, Chapter 1, Guideline on the readability of the label and package leaflet of medicinal products for human use, the rules governing medicinal products in the European Union, Notice to Applicants, Volume 2C, Guidance concerning consultations with target patient groups for the package leaflet, the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2C, EMA Operational Procedure on Handling of Consultation with target patient groups on Package Leaflets (PL) for Centrally Authorised Products for Human Use, overview of biological active substances of non-recombinant origin, EMA pre-submission guidance for users of the centralised procedure - List of questions, EDQM - Certification of Suitability to the monographs of the European Pharmacopoeia, CMD(h) Overview of biological active substances of non-recombinant origin, new linguistic review process of product information in the centralised procedure, Further details on the mock-ups and specimens requirements are available on the EMA website, The new linguistic review process of product information in the centralised procedure (EMEA/5542/02 Rev.4), Timetable for generic applications (EMEA/327896/2005), European Public Assessment Reports: Biosimilars, Guideline on good pharmacovigilance practices (GVP) 3, Notice to applicants Volume 2C, A guideline on summary of product characteristics, Notice to applicants Volume 2A, Chapter 5 variations, EMA post-authorisation guidance EMEA/H/19984/03, Volume 9a of the rules governing medicinal products in the European Union. 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