Public Consultation on Key Principles for Electronic Product Information for Human Medicines in the EU
Total Page：16
File Type：pdf, Size：1020Kb
Contribution ID: 0ec45790-026b-4c03-b574-c265d25fc48e Date: 08/07/2019 12:33:57 Public consultation on key principles for electronic product information for human medicines in the EU Introduction The purpose of this public consultation is to seek views from the public on EMA’s proposed key principles on electronic product information (ePI) for human medicines authorised in the EU. These principles will be used to guide the progress of future work on ePI. The consultation will remain open until July 31, 2019. This questionnaire should be completed once you have read the draft key principles document. Additional background information on the initiative is available in the ePI workshop report. Data Protection By participating in this survey, your submission will be assessed by EMA. EMA collects and stores your personal data for the purpose of this survey and, in the interest of transparency, your submission and identity will be made publicly available. For more information about the processing of personal data by EMA, please read the privacy statement. Your name Your email You are a: Member of the public Patient/consumer Patient/consumer organisation Healthcare professional Healthcare professional organisation Academic Media Pharmaceutical industry Health Technology Assessment Body EU/EEA national competent authority European Institution EU agency Non-EU regulatory authority Page 1 of 235 Other Name of your organisation: Synthon BV Indicate the key principle you would like to comment on (select all that apply): 1.1 ePI 1.2 Common EU electronic standard 2.1 Expanding access to information 2.2 Accessibility 3.1 Complementing paper package leaflet 3.2 Open access to regulator-approved information 3.3 Data protection 4.1 Governance 4.2 Flexibility in implementation 5.1 Multilingual ePI 5.2 Interoperability Detail your comment, rationale, the document line number and any proposed changes for principle 1.1 ePI: Enter any general comments you may have: We would like to know if this also applies to generic pharmaceutical companies? If yes, should we follow the originator (and where can these be found)? What if there is an MA, but we are not marketing the product. Should we still comply? Thank you very much for your contribution. We value your opinion and encourage you to inform others who may be interested about this consultation. Page 2 of 235 Contribution ID: 1cb397b1-9575-44e4-882f-1792cd24713f Date: 31/07/2019 11:48:19 Public consultation on key principles for electronic product information for human medicines in the EU Introduction The purpose of this public consultation is to seek views from the public on EMA’s proposed key principles on electronic product information (ePI) for human medicines authorised in the EU. These principles will be used to guide the progress of future work on ePI. The consultation will remain open until July 31, 2019. This questionnaire should be completed once you have read the draft key principles document. Additional background information on the initiative is available in the ePI workshop report. Data Protection By participating in this survey, your submission will be assessed by EMA. EMA collects and stores your personal data for the purpose of this survey and, in the interest of transparency, your submission and identity will be made publicly available. For more information about the processing of personal data by EMA, please read the privacy statement. Your name Your email You are a: Member of the public Patient/consumer Patient/consumer organisation Healthcare professional Healthcare professional organisation Academic Media Pharmaceutical industry Health Technology Assessment Body EU/EEA national competent authority European Institution EU agency Non-EU regulatory authority Page 3 of 235 Other Name of your organisation: Italian Medicine Agency - AIFA Indicate the key principle you would like to comment on (select all that apply): 1.1 ePI 1.2 Common EU electronic standard 2.1 Expanding access to information 2.2 Accessibility 3.1 Complementing paper package leaflet 3.2 Open access to regulator-approved information 3.3 Data protection 4.1 Governance 4.2 Flexibility in implementation 5.1 Multilingual ePI 5.2 Interoperability Detail your comment, rationale, the document line number and any proposed changes for principle 1.1 ePI: General Comments Additional risk minimisation measures should be included. In some cases, videos are part of additional risk minimisation measures (e.g. Obizur with an on-line video to further elaborate on the required calculation and administration of the drug for HCPs). Healthcare Communication Letter and EMA press releases should also be considered. Additional information approved by CHMP/NCAs (e.g. videos, etc) as well as Blue-Box information should also be considered. Detail your comment, rationale, the document line number and any proposed changes for principle 2.1 Expanding access to information: Page 4 of 235 General Comments With the ePI also the Reporting of suspected adverse reactions could be possible. Provision of the latest information on a medicine’s safety, benefits and its conditions of use, cross-reference to other medicinal products information (e.g. those taken in combination as per indication or with known interactions) and to diseases could also be possible. Updated text should be highlighted respect to the previous versions. An ePI updated in real time, with further navigation and search functions, audio contributions, images, videos, dosage calculation help and phone numbers to be contacted with a simple click in case of need, would be helpful for benefit of patient safety. Following line 159, we propose to add the following text: They can also select the medicines of their interest, having thus available all the information on the drugs, automatically updated. The update of new information should be reported to the user through a notification system and/or pop up. Following row 169 we propose to add the following text: The electronic PI could be extended with a menu of new options and additional features such as an advanced search function or a browsing feature which allows to visualize, without limitations of format or size, authorized videos (e.g. an explanatory tape on the method of administration of a medicinal product), audio formats of texts (useful in case of dyslexia, blind or visually impaired and, although rare cases, of illiteracy), links to the competent authorities’s website in order to facilitate the reporting of suspected adverse reactions by an authomated upload of the reports in the Pharmacovigilance database. Row 179 - 182, the following wording should be clarified: “Correct ePI depends on the medicine batch: some parts of the ePI may be applicable to all batches and some only to specific batches (e.g. when excipients change). Therefore the need for the correct ePI to be supplied for the medicine batch should be taken into consideration.” AIFA comment: It is not clear which are the cases where the ePI is batch-specific (i.e., only applies to specific batches). Referring to the example provided on excipients, actually, all batches with one MARKETING AUTHORISATION NUMBER, must have the same composition. Following row 179, we propose to add the following text: As indicated in the Key Principles, the ePI should be available even through an App, in order to be able to use the application without internet connection, and to consult the documentation previously downloaded by the same user. Footnote 5: The link to the EMA guidance should be to the single EMA document "Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products" Page 5 of 235 Detail your comment, rationale, the document line number and any proposed changes for principle 2.2 Accessibility: Row 186: we propose to integrate the text in brackets (e.g. use of large font size,) with the following: " translation in different EU Braille codes". Text should read: (e.g. use of large font size, translation in different EU Braille codes) Detail your comment, rationale, the document line number and any proposed changes for principle 3.1 Complementing paper package leaflet: Row 217, add the text in inverted comas: The paper PL "and outer labeling" should include a statement directing to the ePI as the most up-to-date version of the PL. Detail your comment, rationale, the document line number and any proposed changes for principle 3.3 Data protection: Please take into consideration the following opinion given by the QRDWG regarding the cookies in video: "There is no legal basis for the EMA to provide any opinion/recommendation on cookies & privacy as to the appropriateness of their presence, as this would be out of EMA institutional remit and potentially interfere with the compliance obligations of the company with national Internet legislation and/or data protection legislation. Given that the MAH is the sole responsible for maintaining and managing the website, they are, therefore, responsible also for the processing of personal data connected to the operation of such website in accordance with the applicable national data protection legislation. However, the MAH should ensure that these elements of the website are consistent with what they committed to by signing the declaration form for the QR code and do not have any promotional aspect." Detail your comment, rationale, the document line number and any proposed changes for principle 4.1 Governance: Row 271 Figure 1: As pointed out (row 271) the burden to convert final PI to ePI is on charge to MAH. In order to preserve a certain homogeneity in the file conversion, we deem more appropriate that it is up to the NCA to perform directly the transformation to ePI at the end of regulatory evaluation (otherwise in case of initial submission of ePI will it be included in the actual eCTD version or is it expected any evolution of the eCTD format?) instead of the MAH.