Empower Your Business with a Sales Automation System in European Union

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good afternoon colleagues it's two o'clock here in Amsterdam and we'll we'll be starting the webinar on upd for marketing authorization holders and particularly focusing on submission of volume of sales data first I would like to welcome everybody to this webinar my name is behan mustafoth I work at the veterinary medicines division of EMA I'm currently the upd Emma product owner my colleague Anna Vicente is from Information Management division of Emma and she's the business analyst today we also have with us Eva Martinez from the Emma service desk as well as few colleagues from the Emma change management team that support the upd now um some housekeeping rules the presentation will be made available on the events page in the upcoming days the webinar is being recorded and by participating you agree with that the recording will be made available on events webpage and my YouTube channel in due time if you are experiencing video or art audio issues please exit the meeting and log in again make sure you select the correct audio outputs should you continue experiencing issues please contact virtual meetings at emma.europa.eu by default all attendees are muted questions can be typed into slido interactions via slido is voluntary and you may opt to remain anonymous if you choose to use slido you consent to the processing of your personal data please note that it is not possible to post questions directly on WebEx in order to access and to access the slider side site please scan the QR code with your phone or go to slido.com and input the code 3024790 take a note of it but if you didn't manage don't worry the code is also written on every slide in this presentation as this session is dedicated to volume of cells we'll focus on this functionality only questions related to any other upd functionalities will not be visible and remain unanswered from now on you can type in your questions and the product team will try to answer them at the end of our presentations presentation or in writing as we go provided that we have the time and capacity due to time restrictions we may not be able to address all questions during the Q a part do not worry if your questions have not been answered these will be collated and addressed in a future webinar or frequently Asked question document published on the agency website we'll start with a demo followed by most frequently reported issues and some tips and tricks to avoid errors we plan 15 minutes for Q a around 2 40 this afternoon as we anticipated um some questions which will be related to what data and by when should be submitted let me try to clarify here as announced at the last vet medicines info Day in February 2023 the submission deadline for annual volume of sales for the 2022 data is by the end of June 2023 and will not be extended this was also clarified last week at a meeting with representatives of Industry Association and I believe that you will hear from your respective associations very soon or maybe in the meantime you already you were already informed please submit as much data as you can for the 2022 EA sales for centrally and non-centerly authorized medicines and as complete data as possible do not submit non-ea cells at this time it is understood that some packages might still not be correct in the upd and submission of 2022 sales data for these packages might be obstructed therefore when Justified that data is not expected National competent authorities have been reminded and will be reminded um at frequent occasions that packages should not be deleted and replaced with a new entry for the same package they should also uh avoid swapping the content the content I mean the data of two packages package IDs must be kept as stable as possible next year when submission of 2023 sales data becomes mandatory then you should be submitting complete data sets before closing the meeting will give you an overview of helpful information and supporting material and without further Ado I'd like to pass now to Anna Vicente so thank you very much beihan and good afternoon everyone please go to Nexus slide before going to the demo let me first highlight that this webinar has been prepared to demonstrate how a marketing authorization holder can provide volume of sales data to the union product database and it is mainly focused on those users who will perform this process manually using the application Excel so here we have the five steps that the user will need to follow the first one and in this demonstration a user from so it is a marketing authorization all their phone so it is will perform all these five steps so the first one after having login into the Union product database portal the marketing authorization Holder will retrieve all the information for all the packages that are under his responsibility this information will be really useful because it will help the marketing authorization holder to do the mapping between the packages in upd and the packages in the in their own systems in The Next Step the user will need to prepare the CSV file with the volume of sales and once that is ready it will be submitted in the fourth step the user will check the status of the submission and whether it has been successful or not and finally if the submission was successful the marketing authorization Holder will be able to retrieve the volume of sales data in upd and now become please proceed with the demo this is the union product database portal and the first thing that they will do is to login into the Union product database as mentioned before I will represent an employee from so it is so I need to provide my user my password and now once that I am in I will go to the volume of sales area which is located within the other post authorization data the first thing that I will do is to download the list of packages and now by pressing the download button the system will generate a CSV file containing the information concerning the packages for all the products belonging to the organizations I am Affiliated too the CSV file will be a store in my computer in the download area so here we can verify this is already done now how to open the CSV file there are different ways to open the document and what what we will demonstrate today is the one that based on our experience has even the best results this method is also explained in the chapter 7 of the BET implementation guide we will use Excel to open the CSV file that separates the information in each row by commas then I'm going to launch Excel and we need to open a blank workbook we need to go to the top data set up data get data from file from CSV file and now we select the document that we have just downloaded so I take the document and now the system will do a representation of the data in one table it seems that there are all the information it's okay so we are going to transform the data and finally we need to save this transformation so we press on close and load and now we have all our packages in this CSV file in Excel so in this case we have 8226 packages foreign of sales file that contains from column A to column M information related to my packages and from column and column s the information that I will need to supply so we have here product identifier product name permanent identifier authorization procedure number pack identifier and pack description box size numeric value pack size unit of presentation unit of presentation identifier country and Country identifier marketing authorization number and creation date of a product the rest of the columns is the information that we will need to supply and before starting to prepare the data Please be aware that you have the flexibility to decide the number of products to be included in each one of the submissions and you also have the flexibility to decide the periodicity with which you will make the submissions as long as the annual volume of sales are in updates gr by the deadlines established by the agency now in order to prepare the volume of sales file I will need to select the packages for which I want to provide the volume of sales and for this exercise I have prepared a product with a single package that is valid for two targeted species dogs and cats so my product name contains product 1 and once selected I will need to remove the rest of the products on the file and again there are many ways to do it I will just make a one I want to I will highlight in yellow the product and now I will filter by all the products that are not highlighted in yellow and these are all the products that I need to remove so I'm going to select the whole table and I will tell to excel that I want to delete all of them so delete entire sheet row and now if we filter again white color or if we clear the filter we will see that our Excel file only contains one product we will convert now to numeric value the numbers of 12 or more digix that Excel has converted to scientific notation but first I will try to feed all the columns into the main screen now I will select the three columns which are with scientific notation that is the permanent identifier the pack size unit of presentation identifier and the country identifier and we will convert to numeric and without decimals remember that information that will be considered by the system for the volume of sales is the package identifier the country identifier and the specific information for volume of sales all the rest of the information even though we can submit with the file will be ignored by the system and now let's proceed with the submission of volume of sales and with our scenario uh I will provide the volume of size for the year 2022 where we had sales only between January and June and as explained before there is no need to provide zero sales for the period between July and December because we didn't have any sales so let's start with January January we have here the six rows now following the guidance from chapter 7 we need to provide a row per package per country and per species therefore given that we have two species dogs and cats we need to duplicate the number of rows and this detail is very important since we have users that were trying to enter two species into one cell so we have we have here the all the months and now we are going to order by date so January to June now uh I will also replicate the values on the rest of the cells and we will start providing more detail on the volume of sales data we are going to provide the species and please view in mind that we need to retrieve the identifiers from the species in the RMS list of a species and know the target the species one okay so this is the value for cuts and this is the one for dogs now we will convert into numeric value again we remove two decimals and now we have here the value for cats and for dogs that we will replicate as well into the other cells next we are going to provide a volume of sales and let's say that for January we saw 100 units 200 for February and so on foreign split represents the percentage of sales over the total for each of the species for European economic area sales the total for all species for one package should be 100 whereas for non-eea sales there will be a margin of Tolerance let's say that for the month of January out of the 100 packages that were sold 70 percent were sold for cuts and 30 for dogs now for the rest of the packages and for the sake of Simplicity we will add the same number to all of them 50 percent Now we move to the dose factor that represents the average number of animals of a particular species that can be treated using one package so let's say that we need 0.5 packages to treat a cut and one package to treat a dog and finally the comment field is optional and can be used to provide extra information to consuming systems like pharmacovigilance now that we have all the volume of sales information ready we will need to prepare the file to be safe as csb so first we will need to remove the empty sheet a csb does not support workbooks containing multiple ones so we go to this tab and we delete it now we only keep one and second we will need to clean the format of the cells before converting the document as we want to reduce the chance of adding unwanted characters to our document during the conversion so we are going to place the cursor um on the table we go to the table design option on top and here we will tell to excel that we want to convert to range we will accept the message and now it's not anymore a table even though we see the colors of a table so now we are going to delete all the colors as well I will take this is one of the different ways that you can do you can perform this action I will take the rows the format of the row 14. and I will apply the same format to the rest of the cells and now our document is ready to be saved we go to file we save the document and we want to save it in our folder and we will need to add descriptive name webinar 24 of April product one 2022 we indicate to excel that we want to save a CSV file command delimited and now we save it got it and now is ready to be sent to be submitted it is time to submit the volume of sales and to that end we will return to the upd portal once inside we will navigate again to the volume of sales section and this time we will select the option submission of volume of sales here we will need to select our file and now we are ready to submit if you get the error number four which is a normal scenario we recommend to review the document but this time open it with a text editor like Notepad I move to my folder and I open with Notepad once there I will check if my document has white lines at the end of the document so as you can see with the cursor we have a white line so we need to remove it by deleting one space and now due to the configuration in my computer Excel has saved the document with semicolon instead of with commas therefore I will need to replace all of them so I go to edit replace and then replace all and now we can save the document and it's ready again for submission so save close and now we return again to the volume of sales and now we will try to submit again the new file we delete the error message we select the file and we press once again the bottom if the submission pass validation the system will send me to the view submission or volume of sales page where I will be able to review its status and as you can see on the right side the submission status is in progress while the submission is in progress I will show you what would happen if the document had contained errors in that case the system will generate an error report in CSV format indicating the type of error in each Road affected so we are going to take this one as an example the system generates the error report I will open with Excel it will change Now using another way the Excel to a more readable format I go to data text to columns transform delimited by comma and here we have our report of Errors so we only have one error in all the rows and is that the package identifier provided does not belong to a product under the user responsibility in the chapter 7 of the vet implementation guide you will have the complete list of errors that might happen and now we will come back to the upd portal since the submission has a valid status now you might want to see the volume of says that you have submitted so we go to the last option in the menu of volume of sales view volume of sales and once in this screen the first thing that we will need to do is to select the product for which we want to see the volume of sales and the second step to select the period of time for which we want to see this data Choice the year 2022 from January to December 2022. now we press the download sales and the system will generate a new CSV file containing this information here is the report we launch again Excel I will convert now to a more readable format information so I select the first column I go to the data tab I select text to column delimited by comma and here is the information that we were submitting before so we can also again change the format of the scientific uh numbers and here you can see that this is the information that we had submitted during our session so for generally 100 200 for February and so on and of course we don't have volume of sales for the months from July to December and this is the last step in the submission of volume of sales thank you okay so now we are going to continue with the presentation uh and to mention that in order to prepare this webinar we have counted with the collaboration of the EMA service desk team they have provided very valuable information on the user experience in the context of the volume of sales and that has helped us to identify the most relevant challenges and the most common questions asked by the users so we will start first with the challenges uh the first one is when trying to open in the download file of volume of sales so data may appear corrupt and while for some of the users the file appears correct by Sim simply double clicking and opening the Excel file for others the file appears grouped due to the user's original configuration in that case please follow the recommendation from the video that we have just prepared for you and it will be shared in order to avoid this corrupted data and similar to the next one of the challenges that is when trying to submit the volume of sales so the error number four the number of columns provided is not correct this error is mainly caused by Excel corrupting the data when converting to a csb format the data that has been prepared and this is again due to to the regional configuration so please follow our recommendations uh the next one next Point compiles different issues related to the data format also mentioned it in the demo phase one numbers turned by Excel into scientific notation addition of multiple values in the same cell empty lines or extra rows after the last row in the Excel file and the use of semicoloma separator instead of a coma and finally the use of RMS terms from the target species list is we need to highlight because some users are using from the target the species list from RMS and you should use only a terms from the species list next slide list now moving to the most frequently asked questions the first one is the accepted which browsers are accepted by upd so upd has been implemented to be supported by Chrome and Edge therefore we discourage users from using other browsers like Firefox that for example does not recognize the csb file format for volume of sales uh the second one is the reported volume of sales for packages that were deleted in upd because were created in error so a packaging upd can be deleted by a competent Authority for two reasons as a result of a variation or because it was created in error by the user in both cases the package will appear in the CSV file and sometimes will be difficult for marketing authorization holders to identify which are the valid packages for which they need to support or to provide the volume of sales for this reason and during this first year of reporting it is assumed that some inaccurate data related to this issue could be reported to upd and finally submission of several sales here to emphasize that there is no requirement to submit zero sales against Parks which have not been sold next slide please and here we have prepared some takeaway messages we think are really important we have been also reading your questions and we hope that these takeaway message is answered a lot of them so the first one the volume of sales value for each month must be the same so if you see on the screenshot in the column all we have a one package for two target species and the volume of sales is the same number is 100. um related to a species first a species film shall be filled in with one term from the species list and not from the targeted species list next for each of the species in a package there must be a row in the CSV file except for those species for which no sales were made unless one related species the species percentage for each species for eea sales should be a number and also are allowed for decimal places and next one no specific naming convention is required for the name of the file and next when submitting the volume of sales file the time to completion of the business validation will depend on the server load so if you are submitting large files for volume of sales please try to come back yeah a few minutes hours later and if you see that it has not been processed yes yet then even try next day a next slide please so if there are errors in your submission file the system will generate another CSV file a report of Errors like it has been demonstrated containing an error message at the end of each row where it has encountered an issue a next a single error prevents the data upload of the whole submission or submitted CSV file so it is essential that a complete corrected file is resubmitted so you can do either do correct the data and you submit the file or you delete that consistently the data that has errors just submit the correct data and then you handle the errors in a in a later stage um now for user users developing system systems to submit the volume of sales it is essential that the file that the file your system produces does display the mandatory data and this has been also mentioned in the demo so you only need to provide the mandatory data that is the package identifier country identifier gr month volume of sales a species identifier a species split and those Factor um and now to highlight the last point that you don't need data in the columns which are not mandatory but you also may find it useful so some users uh we have um it has been designed like this you might find useful to have all the information and to understand uh the complete information of the package and if you submit like it was uh recorded during the video If you submit all the columns the system will ignore and will not have validations for those ones that are not mandatory and with this a we have concluded the takeaway messages uh handing over to you behan thank you thank you very much um Anna okay I will stop sharing now it is um 235 I would like to apologize for the um [Music] fold that we had with them with the video but I hope that you managed to follow because I know that a number of you were also posting um questions and I hope that you will be able to go back to this video when it is published and you'll find this information useful with this I will now pass on to uh Christina and she will be sharing the the questions and we'll try to address them as much as we can in the next 15 minutes thank you thank you very much Bayan for for handing over and thank you to all the participants for being very active during the session and already sending a lot of questions uh we will start from the most voted ones uh please note that uh while we are answering the question live you can still upvote uh the questions that you want to hear answer the most so feel free to join again through the code or through the QR link that you see now displayed and continue noting the questions so let's start with the first one the most voted one upd only contains products for UK and I but the sales data typically come from the entire UK is it acceptable to submit full UK data to UK and I entries in update uh doing otherwise might not be possible due to the way companies are keeping the information okay I will try to address this one at uh present um we need only information for the eea sales and I would like to clarify here that in my introduction I didn't say that only for centrally authorized medicines um what I said in my introduction is that please submit as much data as you can for the 2022 eea sales for centrally and non-centrally authorized medicines and as complete data as possible of course if you have any issues with the specific data package we will understand uh due to errors in upd or incomplete data for that package in upd we will understand that the why this this information about a specific package cannot be provided and we are not talking about products we are talking about uh packages and with this um now the question um of course at present we have only um information on marketing authorizations for the UK Northern Ireland uh territory and we are interested only in these uh data uh because the functionality uh which I was planning to let you know about this at the end of of our slides is that a new functionality about marketing authorization holders that will give the market authorization holder the possibility for product go grouping um will be introduced um later this this quarter and we believe that this will greatly simplify the submission of uh non-ea cells and in the future the Third Country uh product names for marketing authorization holders uh therefore at present we uh do not expect from you and we ask you not to submit uh a non-eea sales data because when the functionality is there this is going to greatly uh facilitate your work as well and as I said the functionality will be in production by the end of this quarter so if you can please try to submit as much as possible data for the UK Northern Northern Ireland territory thank you thank you very much let's go to the next um Most Wanted question in your example the dose Factory is 0.5 and you mentioned it is 0.5 packages to treat a cat but ing to the description of the dose Factor would it be two cats can be treated by a package and the dose Factor would be two okay give us give us a second we are reading the question again okay um in relation to to this I would like to to clarify that a a extensively um revised chapter seven uh is going to be published uh tomorrow um the version that it is at the moment on the uh agency website is I believe 26 uh Pages we have included a lot of information based on the um feedback and also experienced uh gained the revised chapter is um 46 Pages at present um and it's going to be published uh tomorrow it also gives an examples and clarifications I we hope that this is going the these new um and extensively uh updated chapter 7 will provide you with um a useful um guidance which you will be able to to use um for for the submissions and my my advice to you is um because the document is not in truck changes uh please read the the document and when you have um questions or if you would like to get some further clarification please um raise your questions via them ask EMA and we'll provide you with the link at the end of this presentation thank you thank you ma'am okay next one is for the Target species that are not mentioned in ball 9B standard weights which sources will be accepted in order to calculate the dose Factor okay um in relation to this my advice will be of course just try to to um raise this this question via the uh ask a EMA because it is a general question however these um you you have been um submitting information about um those factors and um you know very well how the the submission of such information uh under the old legislation was was working and in the uh for the psurs so you have a lot of of experiences and um unless you are unable to find the clarification um in the updated uh chapter or chapters you can always um liaise with us via them ask me ma you also um have and we know that the colleagues in the pharmac vigilance working party they also have regular meetings with a stakeholders you have the possibilities also to raise questions via these forums which hopefully the colleagues from the pharmacovigilance team will be able to respond because the best knowledge they have the best knowledge in relation to this thank you thank you okay next multi most voted question is we have multiple Distributors across you is our aim to get data from Distributors are we allowed to submit multiple files to the system so I will try to answer this one if I understood properly the question is so marketing authorization holder you will need as a marketing authorization holder you will need to capture or to gather all the information related to your sales how you will submit this information in upd is up to you so a file you don't need to submit all the products in one file you can split it in either way so you can decide to submit even even for one product or you can decide by distributors or any other yeah thing that you consider that is useful for you so upd is not expecting a whole complete file of sales you can split the information as you want thank you very much Sona for your reply next question if there are no volume of sales and we have already entered months in column is it okay to enter 0 as a value or not to enter a month at all for products with no sales Christina that answer has been provided in writing to the to the question in the okay okay we can we can we can read it we can read it I can read it the answer to this question is in case you have provided the months then please provide zero as the system is expecting a number otherwise the validation will fail you can also delete the rows and then not submit sales for those packages thank you very much Katarina okay will the Q a section from slido also be published together with the rest of the webinar materials um yes um we'll try to publish the video recording the presentation and also those questions that we managed to to answer uh and these will be published um I I would like to um now use the opportunity to say that of course them some questions may be um or some are not questions that are comments that's that's why you may not be able uh uh to see them um it's um I will not read them some of the comments be because um in the interest of of time but um again this is this is um a webinar only for them for the volume of uh sales and um Christina next yes clear speaker companies will have thousands of packages is there any recommendation for automation okay um as far as we are aware some companies um have already I'm heavily invested in um into Automation and um it's um at present if um they have any issues they try to draw address uh them manually but of course we are working with the subject matter experts from the industry and also from the ncas we make meet on a on a weekly basis we discuss as well with um colleagues across the the network to receive a further feedback and in due time uh I it will be also uh possible to make a further improvements into the volume of sales but this will be a step-by-step gradual process thank you since there is the possibility that for 2022 only unlimited data set will be submitted how will this be clarified when publishing the data especially considering comparison over years um okay I don't um I'm not quite sure what these what is meant by a limited uh data set I'll unfortunately I will have to repeat myself try to submit as much as you can data we have received a feedback from um industry Representatives that to a very very large extent um including um the big companies they uh are in a position to submit um data and some are already doing so um I would like to clarify again that we are not asking to submit only a limited uh data set and um in of course the 2022 um we will accept if there is there are some data gaps but these will need to be really on a Justified uh grounds and gradually in 2020 through three for the for the volume of cells of uh sorry in in 2024 for the volume of sales in 2023 uh data set I'm sure that they this will get better and better tomorrow there is a webinar for the national competent authorities uh in order to address uh data quality issues a uh for products per countries and um we we are also working uh with the with the ncas very closely and trying to address uh these issues as soon as possible but we understand that um that it may take some months but this will be for a uh let's say it might be on a data package and for only a small number of products just to remind you that we have 45 000 uh products in uh in upd and to a very large extent uh we understood that uh companies are in a position uh already to start submitting and some are submitting thank you thank you Ben said along the presentation that you have already reminded ha about answering petitions about incorrect or missing presentations to be edited or added on ubd how can we proceed if we've been waiting a few months and no answer is given to us I can take this one Christina so it is it is uh we understand the concerns behind it uh as my colleague behan said the first step one of the steps being taken is the a meeting tomorrow with the NCH to highlight some um data issues to to be addressed but at the same time you should an apologies for rephrasing this way you should insist in the context in contact the ncas uh in the HMA website you have a list of procedural contact points for each member State and you have a series of email addresses that you should reach out and request the the the update of the data now having said that if you don't know if you should be contacting the RMS or the CMS for the correction of the data I would further advise you to look into Annex one of chapter 2 that makes a clear distinction between what is the common data and the National Data we understand those those concerns and we understand that you need to reach out as quickly as possible to the NCA so please use these two guidance one the con the procedural contact points in the veterinary section of the HMA website and to Target your requests check if you are if you need to update or change the common data or the National Data and this information is available in the annex one of chapter 2. thank you Katarina okay um thank you Christina uh I would suggest to try to address the the next one uh the next question and uh maybe also the the last one that we see uh now in the interest of time I would like to to address only only this one and then I'll move to to my next light okay sure if I have submitted among from Can I submit an updated CSV file and replace the previously submitted month so I will take this one a yes so that's the way to correct the data so if you submit a new CSV file for the same month uh the new data will override the existing in upd so that's the way to do the correction thank you thank you thank you very much um Christina okay um I would like to share now and continue with the with the presentation foreign materials we have um you are well aware that we are constantly working and Publishing bite-sized uh videos on the agency uh website um there is also a link to the upd introduction webinar for the industry from from last year um at the same place we are going to publish the way the recording from this webinar we also are working on them uh question and answers which are currently under revision we have on variations and um also based on the feedback received um today as I said we'll try to publish these on um that were received on on slider and that all those that remain unanswered will be addressed either at future webinars or um at other question and answer documents uh please also um keep an eye on the frequently published upd release notes uh we have listened to to your feedback and we are working on a executive summary which will which is going to be uh on the first page of the release notes and gradually it will be uh updated further uh you are aware about the upd implementation guide and as I said um today the chapter 7 version 1.4 uh is expected to be published within the next couple of days actually we requested the web team from from the web team to be published uh tomorrow um and don't forget about the best practice guides from cmdv and also very important uh on the cmdv website you will you are also able to find the list of contacts per ncas um published I also told you about the new functionality which will be introduced later this quarter uh about the product grouping and also about a touch country product names and other functionality uh when um these are launched uh further information of course will be uh provided other potential new functionalities in 2023 which are on our um radar is a test environment where the market authorization holders will be able to test their submissions against products in the product in production environment without having to record uh the data are also a date of creation of package and date of deletion of a package to be included in the download file for volume of cells and another one which is on the submission of volume of cells which is about uh non-eea percentage tolerance for volume of cells which we are currently working on a on a change and it will be possible to submit uh plus minus five percent of um difference for the non-eea cells for the eea cells E3 will remain uh 800 percent and now I'm moving to my last slide which is about the support channels that you have um for system related and product or procedure specific issues uh please contact us via the MS service desk for the upd and be aware that very soon uh the MS service desk will be replaced by Emma service now this is the same service which you use for the EV vet related issues and a communication about this is going to be to be sent uh by email and we expect this to be soon as well for any general queries uh please contact us via ask EMA and last but not least uh from first of July 2023 the vet change program at emma.europa.eu email will be discontinued and soon you'll start to receive an auto reply message if you post an email to this mailbox saying that from first of July these functional mailbox will be discontinued and with this um our we are at the end I would like to thank you all for the participation for the active contribution on questions very useful we had more than 250 at some point there were nearly 280 attendees thank you very much I hope that it was useful for you and I'm looking forward to see you in another webinar thank you enjoy the rest of the day