EEC Decision No. 18 Rewrote the SmPC and Package Leaflet Rules. Here Is the Deadline for Registered Products.
A medicinal product’s registration dossier can sometimes stall during regulatory review over a single phrase in Section 3 of the package leaflet that four out of twenty test participants failed to understand. By that point the clinical data has already been agreed; what raises questions for the reviewer is wording meant for an ordinary reader without a medical background.
User testing remains one of the few regulatory procedures in the Eurasian Economic Union (EAEU) where the outcome is decided by a reader without medical training. The reviewer at the competent authority only assesses the submitted report. Since 19 April 2025, an updated version of the requirements for the Instructions for Medical Use of a medicinal product (package leaflet) and the Summary of Product Characteristics of a medicinal product (hereinafter, SmPC) has been in force. Decision of the Council of the Eurasian Economic Commission No. 18 of 21 February 2025 (hereinafter, Decision No. 18) rewrote these requirements and set a transition period for products already registered under the Union’s rules. For a regulatory manager, that transition period hides a concrete deadline, one that is easier to fold into a planned variation than to run as a stand-alone procedure.
How Package Leaflet User Testing Works
User testing of the package leaflet (hereinafter, PL) is set out in EEC Council Decision No. 88 of 3 November 2016, «On the Approval of Requirements for the Instructions for Medical Use of a Medicinal Product and the Summary of Product Characteristics of a Medicinal Product for Medical Use» (hereinafter, Decision No. 88). The methodology is described in Annex No. 14 to that decision, while the procedure for submitting results within the registration dossier is set out in EEC Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicines for Medical Use» (hereinafter, Decision No. 78). Clause 1.3.3 of Module 1 of the dossier under Decision No. 78 reserves a dedicated place for user testing results, and a document quality checklist in Section VII helps the reviewer assess how complete the report is.
The test checks two things: whether a reader can find the relevant piece of text, and whether they can correctly understand it. Sections 1 to 4 of the PL are checked above all: what the drug is and what it treats, what to know before taking it, how to take it, and what adverse reactions are possible. Sections 5 and 6, on storage and pack contents, are checked selectively, usually only when new pictograms are added or the text changes substantially.
Testing runs in two stages. A pilot round with a small group of participants catches poorly worded questionnaire items and text. The main round involves at least 20 people from the product’s target population, with no healthcare professionals or pharmacists in the group. The test counts as successful if at least 90% of participants find and correctly understand the information being checked. Companies typically get the report back 4 to 8 weeks after work with a contractor begins, a timeline worth building into the registration schedule ahead of time.
Full testing is not required for every change.
Decision No. 88 names specific cases:
registering a product with a new active substance or in a fundamentally new dosage form for the Union market;
a change in dispensing status, for example switching from prescription-only to over-the-counter;
a significant change to safety information;
adding new clinical recommendations and the patient populations that come with them, including children.
In practice, how demanding a test turns out to be depends mainly on the product itself. A long list of precautions, a complex dosing schedule, and frequent adverse reactions lengthen the questionnaire and the interviews. Manufacturers also regularly point to a specific problem: repeated instructions to consult a doctor or pharmacist throughout the text. The fewer of these there are, the easier it is for participants to focus on the information that actually matters.
Requirements for the makeup of the test group affect budget and timelines too. The sample covers different categories of consumers: the product’s core audience, older people, people with limited education, and, where relevant, children and adolescents. Testers aged 15 to 18 are recruited separately from adults; because they tire faster, pediatric cohorts usually run larger, up to 40 participants. Reading speed, eyesight, and familiarity with reading printed material vary from person to person, and that shows up clearly in how long different participants take to work through the same sections of the PL.
A separate layer of difficulty appears when a PL is issued in two or more languages of the member states. A literal translation does not always keep the meaning and readability intact: a phrase that reads clearly in one language can sound unnatural in another and land worse with test participants. Whoever edits the PL text has to check not just terminology but how each language version actually sounds.
Commissioning user testing from an outside contractor also takes time to set up. If a company selects a contractor through a tender, it needs to prepare tender documents, run the process, collect proposals, and sign a contract before testing can start. That organizational stage is worth planning for separately from the 4 to 8 weeks the test itself and the report take.
The user testing report goes into the registration dossier and includes a brief description of the dosage form, a description of the testing method, the questionnaires used, and both the original and revised versions of the PL along with a discussion of the results. A missing original version of the text is the single most common reason reviewers come back with follow-up questions: without it, there is no way to check which wording caused difficulty for participants or how it was corrected afterward.
Clause 7.3 of Annex No. 12 to Decision No. 88 sets out cases where testing is not required at all. If design and layout changes do not add new words or phrases to an already-tested section, and do not change where information sits or how large it is, repeat testing is not needed. A separate relief applies to a standard portfolio of topical products, such as ointments, creams, and eye, ear, and nasal drops: if they share the same design and the text has no untested pictograms, each PL does not need to be tested on its own.
For a product line built on the same pharmacologically active moiety but different strengths or dosage forms, companies use bridging. A successful test of a parent PL that carries the most complex information for the patient justifies child PLs without a new full test. For example, a PL for diazepam oral solution can serve as the parent for a PL for diazepam tablets, while a PL for an injectable product that requires a healthcare professional to administer it bridges to the PL for a self-administered form. For inhaled salbutamol, double bridging is allowed: to a tested PL for oral salbutamol for information about the active substance, and to a PL for beclometasone with an identical inhaler for information about dose delivery.
Bridging also works within a single pharmacological class, for example proton pump inhibitors with the same safety profile and adverse reactions, and for combination products against mono-component products that have already been tested. Decision No. 88 separately lists groups of products where bridging is allowed and groups where differences in clinical presentation rule it out. One condition applies across the board: the child PL must match the parent’s design, layout, and writing style. For narrow changes that cannot be justified by bridging but only touch part of the leaflet, for example shrinking its size without changing the content, Decision No. 88 provides for smaller focus groups.
Decision No. 18 Rewrote the SmPC and Package Leaflet Requirements
Decision No. 18 was signed on 21 February 2025 and published on 20 March 2025. The main body of the document took effect on 19 April 2025, 30 calendar days after publication. Clause 2 of the document carries a separate date: it took effect on 16 September 2025, 180 calendar days after publication.
Decision No. 18 restated the SmPC and PL requirements in full, rather than as a set of individual amendments. The updated text covers general provisions on SmPC content and approval, the procedure for submitting draft documents for review as text-recognized PDFs, rules for handling changes to originator and generic products, and detailed requirements for every clinical and pharmaceutical section, from indications for use through non-clinical safety data. Annexes No. 14, 17, and 18 to Decision No. 88 still contain the guidance on ensuring readability and on how user testing is conducted.
The main practical point concerns products that are already registered. Clause 2 of Decision No. 18 sets a transition rule: if a product was registered under Decision No. 78 before Decision No. 18 took effect, its SmPC and PL are aligned with the new requirements at the first subsequent variation that requires review. The rule does not call for an immediate overhaul of documents already approved. A marketing authorization holder does not need to open a separate procedure just to update the SmPC and PL template; it is enough to build the new requirements into the next planned variation.
| Parameter | Before (until 19 April 2025) | Now (from 19 April 2025) |
|---|---|---|
| Version of the SmPC and PL requirements in force | Decision No. 88 as it stood before Decision No. 18 | Decision No. 88 as amended by Decision No. 18 of 21 February 2025 |
| Deadline for aligning existing SmPCs and PLs | Not separately regulated | At the first variation requiring review, after 16 September 2025 |
| Need for a separate procedure just to update the template | Not previously addressed | Not required; the update rides on a planned variation |
| Basis for testing, bridging, and exemptions from it | Clauses 4.11, 7.1, 7.3 of Annex No. 12 and Annex No. 14 to Decision No. 88 | In force within the structure of Decision No. 88, Annexes No. 14, 17, 18 |
For comparison: a similar approach to transparency in user instructions underlies the European Accessibility Act, in force in the EU since 28 June 2025. It requires digital versions of instructions to meet the WCAG 2.1 Level AA web accessibility standard, including a text contrast ratio of at least 4.5 to 1. This is an EU instrument, and it does not apply in the EAEU directly. It still points at a direction: a manufacturer already adapting packaging to both markets’ requirements will likely run into electronic product information requirements in the Union too, sooner than others.
What to Do
Audit the SmPCs and PLs already in force across your portfolio. Sort products into three groups: documents already aligned with Decision No. 18, documents waiting for their next variation, and documents that need substantive revision regardless of the template.
Tie the SmPC and PL update to the next planned variation that will need review anyway. A stand-alone procedure run only for the new template adds time and budget without practical need.
Check whether the testing exemptions under Clause 7.3 of Annex No. 12 to Decision No. 88 apply before commissioning a full study. Design changes with no new text and a portfolio of similar topical products often do not require repeat testing.
Assess bridging for product lines that share an active substance, strengths, or a pharmacological class. A parent PL carrying the most complex information covers the testing requirement for child PLs.
Build 4 to 8 weeks into the registration timeline for a full user test and report if bridging and focus groups do not apply and the product falls under one of the mandatory cases in Decision No. 88.
Updating the SmPC and PL requirements rarely calls for alarm once it is folded into the registration dossier’s existing lifecycle instead of treated as a stand-alone project. Companies that check their portfolio against Decision No. 18’s transition deadlines ahead of time, and that know how to use bridging and focus groups, spend less time and budget on user testing than companies that put this work off until a reviewer asks for it.
Regulatory basis:
1. EEC Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicines for Medical Use»
2. EEC Council Decision No. 88 of 3 November 2016, «On the Approval of 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 by Decision No. 18 of 21 February 2025)
3. EEC Council Decision No. 18 of 21 February 2025, «On Amendments to 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»