User testing of the package leaflet in the EAEU. When it is needed, how it is conducted and what to submit in Module 1
User testing of a package leaflet (a check on a group of people to see whether they can find the information they need in the patient text and understand it) is conducted at the applicant’s discretion. This is stated in the Requirements for the Instructions for Medical Use of a Medicinal Product and the Summary of Product Characteristics of a Medicinal Product, approved by Decision of the Council of the Eurasian Economic Commission (EEC) of 3 November 2016 No. 88 (hereinafter Requirements No. 88). The applicant «should make provision for user or similar testing» in four cases: for a product with a new active substance or a fundamentally new pharmaceutical form; when the dispensing conditions change; when significant new safety information that substantially changes the indications, restrictions on use or method of administration is added to the Summary of Product Characteristics (SmPC); and when the indications are extended to a new patient population. For a product registered under the national procedure of a member state of the Eurasian Economic Union (EAEU, hereinafter the Union), test results are not required when its registration dossier is brought into line with Union requirements (dossier alignment). At registration of a generic product, test results are generally not submitted.
If testing has been conducted, the expert organization checks each question separately: at least 16 of 20 participants must find and understand the information for every question. Ratings of «with difficulty» and «with great difficulty» used as criteria in the report are a ground for refusing to recognize the test results.
Which acts govern testing
Federal Law of 12 April 2010 No. 61-FZ «On the Circulation of Medicines» (as amended on 4 August 2026, hereinafter 61-FZ) contains no requirements for checking whether instructions for use are understandable: the words «package leaflet», «readability» and «user testing» do not appear in its text. The instructions are mentioned in connection with liability: under 61-FZ, the manufacturer must compensate for harm to health if it is proven that the harm was caused by inaccurate information in the instructions it issued.
Two acts of the Union govern testing:
Requirements No. 88 (as amended on 21 February 2025, applied from 19 April 2025). They define the objectives, organization and cases of testing, the content of the report and the procedure for regulatory review, set out the standard methodology, lay down readability rules and contain points-based criteria for the quality of the package leaflet.
The Rules for Registration and Regulatory Review of Medicines for Medical Use, approved by Decision of the EEC Council of 3 November 2016 No. 78 (as amended on 26 November 2025, hereinafter Rules No. 78). They define how the results are presented in Module 1 (the administrative part of the registration dossier) and contain a document quality checklist for reviewing the test results.
When testing is needed
| Situation | What Requirements No. 88 say |
|---|---|
| A new active substance or a fundamentally new pharmaceutical form (a different method or route of administration) | Testing or a similar check should be provided for |
| The dispensing conditions have changed | Testing should be provided for |
| Significant new safety information has been added to the SmPC and substantially changes the indications, restrictions on use (precautions and contraindications) or method of administration in a patient population | Testing should be provided for |
| The indications have been extended to include a new patient population (for example, children) | Testing should be provided for |
| Dossier alignment with Union requirements | Results are not required; the applicant may submit them on its own initiative |
| A generic or biosimilar product | Results are generally not submitted; the text of the package leaflet (PL) of a product with the same international nonproprietary name (INN) previously registered in a member state is sufficient |
| The product is administered by healthcare professionals in healthcare institutions | Testing is conducted on the applicant’s initiative or at the request of the expert organization |
| Information that does not affect significant safety information or a new patient population has been added to the PL, or the design and layout have been changed | Repeat testing is not required |
| The expert organization has sent comments on the draft PL | No further testing is conducted; the text is agreed once the comments are addressed |
New active substances are defined as substances from originator products or, where there are no originator products, substances from the first products submitted for registration under Rules No. 78.
Test results are not required at dossier alignment, but Requirements No. 88 allow two exceptions. The expert organization may request the results if the applicant files the application in a member state where the product has not previously been registered. For products with a significant risk of incorrect use in outpatient settings, it may also set a requirement to conduct testing within one year after dossier alignment, with reference to Rules No. 78. Rules No. 78 list additional requirements for registration (measures in the risk management system, post-registration studies, «other conditions or restrictions» for safe and effective use), but do not expressly name testing or the one-year period.
If there are no test results, the applicant submits in Module 1 a letter stating the source of the information on the basis of which the PL was prepared. This provision of Requirements No. 88 names no other consequences of the absence of results.
How standard testing is conducted
A full-color mock-up of the leaflet is tested. Its color, style and paper match the leaflet that will be placed in the pack of a commercial batch. For a multilingual leaflet, the same requirements apply to the language version being tested, including the font size. A text-only version is not permitted, because design and layout affect the patient’s ability to find key information. Testing may be conducted in any language of the member states, provided the text of the PL is identical.
Testing is conducted by the registration holder or a specialized contract organization, and led by an experienced specialist with interviewing skills. The specialist who drafts the PL helps prepare the questionnaire and, where necessary, assists the interviewer. Patient associations and expert patients may be involved in developing the test.
The method consists of standardized individual interviews with at least 20 representatives of the local population for whom the product is intended. Twenty people, not counting pilot participants, are enough to demonstrate that testing has succeeded.
The procedure is as follows:
1. A pilot with approximately 3-6 participants checks that the questions are correct. With experience, the pilot may be limited to 2-3 participants, or the main phase may begin immediately.
2. The results are analyzed as testing progresses, and the necessary changes are made to the PL.
3. Testing is repeated until the result in a group of 10 participants is satisfactory.
4. A further 10 participants undergo final testing to check the success criteria on the final leaflet (20 participants in total).
Participants who have already been tested are not tested again, and the same person is included in another such test no more than once in 6 months.
The participants represent the target population, that is, people who potentially need to use the product. For some products, carers of patients are also tested, but Requirements No. 88 do not say in the standard methodology which products these are. Doctors, mid-level medical staff and pharmacy workers are excluded. People familiar with the product generally should not take part in testing. Information obtained from them may be used to prepare the design of the leaflet. The standard methodology names groups that should be tested and included: older people and children, if the product is relevant to those ages; people who do not usually use medicines; people who read little; and those who find it hard to take in written information.
The protocol is drawn up anew for each product. Before testing, the key information for safe use is identified; as a rule, it is found in sections 1-4 of the leaflet, and the questions cover all such information.
The following rules apply to the questions:
the questions address finding the information, understanding it and the ability to act on it, and the expected correct answers are written down in advance;
12-15 questions are usually enough, and the interview lasts no more than 45 minutes;
general questions (for example, about a missed dose) are combined with specific ones (about an adverse reaction typical of the product);
the questions are worded differently from the text of the leaflet and asked in random order;
the questions are open and do not suggest the answer given in the leaflet;
where possible, instructions for preparing the product are tested on dummy primary packs, with the participant demonstrating the preparation.
Easy questions included to ensure success must not be used, and avoiding serious safety questions is not recommended. The interviewer explains to the participant that the document is being tested, not the participant, lets the participant read the whole leaflet if they wish, asks the questions orally and asks the participant to describe what they have found in their own words. The interviewer also observes how the participant handles the leaflet and whether they get lost in it.
The success criterion is written as follows: 90% of the 90% of participants who find the information must understand it. This means that 16 of 20 participants found what was needed, answered each question and were able to act. The criteria must be met for every question, and results must not be aggregated across the study as a whole. If the results fall below these values, the PL is revised and additional testing is conducted.
The standard methodology shows how the leaflet works in practice and does not confirm the quality of the substantive content of the text. The quality of the substantive content can be checked, for example, with the «Simple Measurement of Text Complexity» test (SMOGG).
What requirements the mock-up must meet
| Parameter | What Requirements No. 88 say about the mock-up |
|---|---|
| Font | Minimum size 8 pt Times New Roman without italics, line spacing of at least 3 mm (for a PL placed in individual packaging). A larger font is needed for diseases accompanied by visual impairment. Italics are acceptable for Latin terms |
| Line spacing | As a general rule, not less than one and a half times the spacing between letters within a line |
| Alignment | Text justified to both margins is generally not permitted |
| Contrast and background | Contrast between the text and the background is needed, and background images are not placed behind the text. Dark text is generally printed on a light background |
| Paper | Thick enough to reduce show-through. Matte paper is recommended. A fold must not reduce readability |
| Lists | Where possible, no more than 5-6 items |
| Adverse reactions | Generally in order of decreasing frequency. A serious reaction that requires urgent action by the patient is placed at the beginning of the section regardless of frequency. The frequency scale is explained, for example «very common» as «more than 1 patient in 10». Listing by system organ class is not recommended |
| Style | Active voice. The instruction first, then the reason. Abbreviations are spelled out at first mention. A plain-language description of a term first, then the medical term |
| Pictograms | Permitted if the meaning is clear and the size is legible. They must not be promotional |
What can replace full testing
The standard methodology of Requirements No. 88 (described above) is named as one of the variants of the user testing method. Other methodologies are permitted if they confirm that patients can find and understand the information needed for safe use of the product, and expert organizations may not require a particular methodology. For an alternative methodology the success criteria may differ, but every question must meet them. The applicant justifies the alternative methodology, and the expert organization assesses it case by case.
Bridging is used for leaflets that are sufficiently close in content and layout. Successful testing of a parent leaflet (the one whose results are used) makes it possible not to test similar daughter leaflets (those that rely on these results). Daughter leaflets may be prepared on the basis of the test results of several parent leaflets. A daughter leaflet must have the same design, layout and writing style, otherwise the expert organization may refuse to accept the bridging. The key information for safe use (the most important information about the product, for example its purpose, dosage regimen, significant adverse reactions and special warnings) may differ between the parent and daughter leaflets. Safety information that raises particular concern is tested for each daughter leaflet.
Bridging is permitted in the following circumstances:
line extension: the same active ingredient in different strengths, pharmaceutical forms and routes of administration, with the leaflet that has the most complex information for the patient taken as the parent;
products of the same therapeutic class with similar clinical particulars in the SmPC and similar information for safe use;
products with identical information for safe use, whose leaflets are designed, laid out and written in the same way;
a homogeneous patient population, and for products used in several therapeutic areas, double bridging (with two parent leaflets);
combination products: the leaflet of the combination product is taken as the parent for the leaflets of individual components, and the leaflets of the components may be used as parents for the combination product if all differences in layout and length have passed testing;
short leaflets for products with a minor therapeutic effect, which generally do not require testing;
non-prescription combination products whose leaflets are bridged to the leaflets of single-ingredient products that have passed testing of the main component;
pictograms: they are checked in testing, and in the daughter leaflet they must match the parent in design, size and color;
leaflets of different manufacturers.
One company may use the leaflet of another if it has permission to access the commercial information, the products are the same (apart from company information), and the design and layout are identical. Different logos are acceptable if they are positioned in the same way and are close in area. The applicant submits a declaration that it has reviewed the testing data of the originator product and confirms that the testing was satisfactory.
The bridging report (the report on the bridging of the daughter leaflet) does not include the original data of the parent leaflet. The applicant first submits the test results of the parent PL and obtains their approval from the expert organization, after which it may file several leaflets at the same time. In the report it states the information for safe use of the daughter leaflet and shows how that information was taken into account in testing the parent leaflet, compares the design and layout, and analyzes the complexity of the information and the writing style.
A focus group is directed at a separate part of the leaflet. It is conducted to justify a particular change to the leaflet after a change to the SmPC, or as an element of initial registration if a separate aspect of the leaflet cannot be bridged to products that are already registered. A focus group has fewer questions, and it is conducted under the instructions for full testing. Participants may be recruited from those invited to the full testing of another product in the same session.
If the instructions are translated into an official language of a member state, the expert organization conducts a focus group study or bridging on request.
What goes into the report and Module 1
The report on the test results consists of the following parts:
1. The key information for safe use, identified in advance for each product, and the basis on which the questions were derived.
2. The selection of participants and their demographic characteristics: how well the sample reflects the likely patient population by sex and age, the exclusion criteria and the level of education.
3. An analysis for each group tested. Each question must meet the success criteria, and questions that caused difficulties are highlighted. If subjective criteria were used, the report describes how participants found the information and analyzes how much easier the search became after the PL was changed. After the PL is changed, testing is repeated and a new report is drawn up.
4. Participant feedback and changes that take into account all questions of a general nature.
5. All versions of the PL.
6. A summary of oral responses. Raw interview data are not submitted, but the expert organization may request them during regulatory review. Individual information on the testing of each participant is not required.
The test results are submitted to the expert organization that reviews the registration dossier and are included in Module 1. Rules No. 78 (as amended by Decision of the EEC Council of 20 October 2023 No. 114) place in Module 1 a summary drawn up on the prescribed form.
The summary includes:
a brief description of the medicinal product;
a brief description of the testing conducted or of the study of individual elements of the PL: the methodology, explanations of the criteria for selecting participants, and the language of testing;
the questionnaires used (question sheets, including instructions for completing them and observation forms);
the original and revised versions of the PL;
a brief description and discussion of the results: participants’ responses, the problems identified and the changes made to the sections of the PL;
a conclusion.
The remaining details are submitted at the request of the expert organization.
Requirements No. 88 name a different place in Module 1: they assign copies of the testing records, including the questions asked, the answers received, the interviewer’s written observations and the different versions of the leaflet, to the adjacent section of the registration dossier. In Rules No. 78 that section is reserved for copies of the SmPC and the instructions for medical use approved by the authorized body of the manufacturer’s country and (or) the country of the registration holder, certified by an authorized person of the registration holder. The acts do not say which of the two sections applies to copies of the records. Before filing the application for registration, the applicant may request from the expert organization a consultation on the completeness of the registration dossier under Rules No. 78.
How the expert reviews the leaflet and the test
The expert proceeds in this order:
1. Checks whether the PL complies with the section of Requirements No. 88 on the package leaflet, including the order in which the information is presented.
2. Assesses the design and layout, including the typeface and font size, and the way the information is expressed, and decides whether the leaflet is readable.
3. Identifies the key safety information needed for safe use and establishes whether it matches the information from the applicant included in the protocol and the question sheet.
4. Reviews the testing or another form of consultation with target patient groups: the data confirming the participants’ ability to understand the information and the suitability of the subjects, for which the report needs information on their backgrounds and relevance to the target population.
If the data show that patients have difficulties with particular questions, the way the information is presented must be revised.
The checklist in Rules No. 78 provides for marks on whether a full or summary report has been submitted, whether the justification for bridging or for not submitting a report is acceptable, and whether the selection of participants, the questionnaire, the number of questions, the duration of the interview, the testing rounds with the pilot and the method of assessing answers are acceptable. It also records whether each question meets the criterion of 81% correct answers (90% of 90%), whether the mock-up and design comply with Requirements No. 88, and whether weaknesses in the PL have been identified and eliminated.
Requirements No. 88 give points-based criteria for the quality of the PL. Three process indicators are scored 1 or 0 points: whether the participation of patients in development is confirmed, whether the needs of special patient groups were discussed, and whether user testing was conducted. The indicators for the leaflet itself include the presentation of the material: the choice of font, the use of capital letters and italics, contrast and line spacing.
What changed from 19 April 2025
The current version of Requirements No. 88 (as amended on 21 February 2025) applies from 19 April 2025. Until 18 April 2025 the version of 19 May 2022 was in force.
| Subject | Before (version of 19 May 2022) | After (version of 21 February 2025) |
|---|---|---|
| Dossier alignment with Union requirements | No separate rule | Results are not required; the applicant may submit them on its own initiative. The expert organization may request them if the application is filed in a member state where the product has not previously been registered, or set a requirement to conduct testing within one year after dossier alignment, with reference to Rules No. 78 |
| Substances for which testing should be provided for | «New chemical entities» without a definition | «New active substances» with a definition: substances from originator products or, where there are none, from the first products submitted for registration under Rules No. 78 |
| Generic and biosimilar products | The applicant «may also» conduct testing | Results are generally not submitted; the text of the leaflet of a product with the same INN previously registered in a member state is sufficient |
| No test results | No requirement for a letter | In Module 1 the applicant submits a letter stating the source of the information for preparing the leaflet |
| Language of testing and translation of the instructions | No separate rule | Testing is conducted in any language of the member states if the text of the leaflet is identical; when translated into an official language, a focus group or bridging is conducted at the request of the expert organization |
| Comments of the expert organization on the draft leaflet | No separate rule | No further testing is conducted; the text is agreed once the comments are addressed |
| When repeat testing is not required | If no new word or phrase has been added to a section that was tested before, and with a change of design and layout the position and size of the information do not change | If the information added does not affect significant safety information or a new patient population, or the design and layout have been changed |
| Ratings of «with difficulty» and «with great difficulty» | Experts «take a negative view» of these expressions, so an analysis is needed of how much the ease of finding the information improved | The use of such ratings is named as a ground for refusing to recognize the test results |
| Module 1 in the standard methodology | The section of the standard methodology on the testing procedure says that testing (if available) is included in Module 1 | That sentence is not in that section; copies of the records are assigned to the adjacent section of Module 1 only in the section on the protocol |
The 16 of 20 criterion, the number of participants, the pilot, the duration of the interview, the 6-month interval between participations and the requirements for font and spacing remained the same.
What to do
Decide whether testing is needed before ordering the mock-up. Compare the product with the cases listed in Requirements No. 88. For a generic or biosimilar product, check that the text of the PL matches the leaflet of a registered product with the same INN. Record the basis: which of the cases applies, or the reason why there will be no results.
Draw up the protocol before the interviews begin. Identify the key information for safe use from sections 1-4 of the future PL and the SmPC. Prepare, usually, 12-15 open questions with expected answers and success criteria, and plan the interview for no more than 45 minutes.
Bring the mock-up into line with the readability rules before the first interview. Check a font size of at least 8 pt, line spacing of at least 3 mm (for a leaflet placed in individual packaging), the alignment, and that the paper and color of the mock-up match the leaflet of the batch. Do not use a text-only version.
Conduct testing in stages. A pilot with approximately 3-6 participants (2-3 with experience), then a group of 10 people, changes to the leaflet and a repeat on a new group until the result is satisfactory, then the final 10 participants. Each question needs 16 of 20. Do not repeat participants or include them in a new test sooner than 6 months later.
Prepare the Module 1 summary and the materials to be provided on request. Upload the summary to Module 1 on the form of Rules No. 78. Keep the full report and the records ready for a request from the expert organization. If there are no results, attach a letter with the source of the information. If the product is undergoing dossier alignment and has a significant risk of incorrect use in outpatient settings, allow for the possibility that the expert organization may require testing within one year. Before filing the application for registration, ask the expert organization in which section of Module 1 to place the copies of the records, with the summary or with the copies of the SmPC and the instructions (a consultation on the completeness of the dossier under Rules No. 78).
Regulatory framework:
1. Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 88 «On Approval of the Requirements for the Instructions for Medical Use of a Medicinal Product and the Summary of Product Characteristics of a Medicinal Product for Medical Use» (as amended on 21 February 2025; the version as amended on 19 May 2022 was used for comparison)
2. Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 78 «On the Rules for Registration and Regulatory Review of Medicines for Medical Use» (as amended on 26 November 2025)
3. Federal Law of 12 April 2010 No. 61-FZ «On the Circulation of Medicines» (as amended on 4 August 2026)