SmPC and package leaflet under EEC Decision No. 88. Structure, language, testing, and texts for originator and generic products
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, approved by Decision of the Council of the Eurasian Economic Commission (EEC) No. 88 of 3 November 2016 (hereinafter Requirements No. 88), divide product information into two documents. The Summary of Product Characteristics (SmPC) is intended for healthcare professionals. The instructions for medical use (package leaflet, hereinafter PL) are written for the patient (consumer) and prepared in accordance with the SmPC. The content of the PL cannot be identical to the information in the SmPC.
Both texts are part of Module 1 of the registration dossier, its administrative part. If the SmPC and PL are prepared without meeting the requirements for the format in which drafts are submitted, for the justification of changes and for the source of the texts, the registration dossier or the amendments to its documents are deemed incomplete. The source of the texts differs between an originator product and generic, hybrid and biosimilar products.
The applicant has no more than 90 working days to submit the missing materials, and these days are not counted in the time limit for registration and regulatory review. The period is set by the Rules for Registration and Regulatory Review of Medicines for Medical Use, approved by EEC Council Decision No. 78 of 3 November 2016 (hereinafter Rules No. 78). The same period applies when registration is confirmed and when the dossier is brought into line with the requirements of the Eurasian Economic Union (hereinafter the Union), known as dossier alignment.
The manufacturer is responsible for the accuracy of the instructions for use. Under Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicines», the manufacturer must compensate for harm to health caused by inaccurate information in the instructions for use that it has issued.
How the SmPC and package leaflet differ
Table 1. The SmPC and PL under Requirements No. 88
| Parameter | SmPC | PL |
|---|---|---|
| Reader | Healthcare professionals | The patient (consumer) |
| Relationship between the texts | The main source of information on the safe and effective use of the product | Prepared in accordance with the SmPC |
| Language | Medical terminology | Language a non-specialist can understand, a conversational style, short sentences and/or bullet points |
| Structure | Twelve template sections; sections 10 and 11 are needed only for radiopharmaceuticals | Six template sections |
| Completion instructions | Separate instructions for the SmPC in Requirements No. 88 | Separate instructions for the PL in Requirements No. 88 |
| Adverse reactions | Grouped by system organ class, within a class by frequency category, and within one category in order of decreasing seriousness | Grouping by system organ class is not permitted; reactions are grouped by seriousness |
| Separate document | As a rule, for each dosage form and in some cases for each strength | As a rule, for each strength and dosage form |
| Publication | The unified register of registered medicines; the website of the authorized body is also permitted | The same |
Under EEC Council Decision No. 84 of 3 November 2016 «On the Procedures for Establishing and Maintaining the Unified Register of Registered Medicines of the Eurasian Economic Union and Information Databases in the Field of the Circulation of Medicines» (hereinafter Decision No. 84), the EEC establishes and maintains the unified register of registered medicines of the Union. The register contains the SmPC and PL for the reference state (the member state that prepares the expert report on the assessment of the product) and for the states of recognition (the member states where the product is registered after that report is assessed). This information is publicly accessible.
Module 1 of the registration dossier is called «administrative information». It includes a covering letter, documents on registration in the manufacturer’s country, the SmPC, the PL and packaging mock-ups. The SmPC and PL materials comprise drafts in Russian, the results of user testing of the PL mock-up in the cases set by Requirements No. 88, and copies of the SmPC and PL approved in the manufacturer’s country or in the country of the registration holder, certified by the authorized person of the registration holder.
Any departure from Requirements No. 88 is justified in the summaries of Module 2 of the registration dossier. Draft SmPCs and PLs are submitted as PDF files with searchable text; a Word version may be provided in addition.
What the SmPC consists of
The SmPC template and the instructions for completing it are set out in Requirements No. 88.
Table 2. SmPC sections
| Section | What Requirements No. 88 require |
|---|---|
| 1. Name of the medicinal product | The trade name, strength and dosage form. The dosage form is given according to the Pharmacopoeia of the Eurasian Economic Union, approved by EEC Board Decision No. 100 of 11 August 2020, in the plural. If no suitable term exists, the term is constructed from the Nomenclature of Dosage Forms, approved by EEC Board Decision No. 172 of 22 December 2015. Different strengths are written in the same way, and decimal separators are avoided (250 micrograms instead of 0.25 mg) |
| 2. Qualitative and quantitative composition | The active substance is given by its International Nonproprietary Name (INN); references to pharmacopoeial quality are not permitted. For salts and hydrates, the quantity is as a rule expressed in units of mass of the active moiety. The section ends with the standard statement that the full list of excipients is in section 6.1 |
| 3. Dosage form | The term from the Nomenclature of Dosage Forms, matching section 1; the appearance is described in a separate paragraph. For tablets with a score line, the section states whether reproducible subdivision has been confirmed |
| 4. Clinical particulars | Subsections 4.1-4.9 |
| 5. Pharmacological properties | Subsection 5.1 begins with the ATC code (Anatomical Therapeutic Chemical classification); if there is no five-level code, the code is given to the greatest possible number of levels |
| 6. Pharmaceutical particulars | Excipients, incompatibilities, shelf life, precautions for storage, packaging and disposal |
| 7. Registration holder | Name, address, telephone number, fax number or email address, but not a website; subsection 7.1 gives the same details for the representative of the registration holder |
| 8. Registration certificate number | The section is completed by the authorized body or the registration holder after registration |
| 9. Dispensing category | By prescription, without prescription or for healthcare institutions; conditions and restrictions on supply and use, if there are any |
| 10. Dosimetry | Only for radiopharmaceuticals; for other products the section is omitted and the following sections are numbered consecutively |
| 11. Instructions for preparation of radiopharmaceuticals | Only for radiopharmaceuticals; for other products the section is omitted |
| 12. Establishment of post-registration measures | The standard wording is included if the authorized bodies have decided to establish such measures |
For a product subject to additional safety monitoring, a special symbol with the standard wording is placed before section 1. The list of such products includes products with a new active substance that has not yet been registered in any member state, products of biological origin, and products for which the authorized body has requested a post-registration safety study (under the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union, approved by EEC Council Decision No. 87 of 3 November 2016). The conditions and restrictions that the authorized body of the reference state has set as additional requirements for registration are stated in the registration certificate, the unified register, the SmPC and the instructions for medical use (under Rules No. 78).
A separate SmPC is as a rule required for each dosage form and in some cases for each strength. A combined SmPC for several forms and/or strengths is prepared when the treatment schedule involves a change in the dosing regimen or the method of administration of the form in use during treatment. For different strengths of one dosage form, Requirements No. 88 provide for combined SmPCs, which must be fully identical except for information specific to the strengths. If the indications for different strengths do not match, SmPCs may not be combined. Information on each dosage form is always presented in separate SmPCs. Strength-specific information in such an SmPC is set off by subheadings of the form «X, 5 mg, tablets».
Clinical particulars
The indication is stated concisely, and the purpose of therapy is specified: symptomatic treatment, treatment of the cause, or treatment that affects the course and progression of the disease, as well as prevention and diagnosis. Age groups are given with age limits in the form «aged X to Y years (months)». The pediatric population is divided into five subgroups: preterm newborn infants, term newborn infants (0 to 27 days), infants and toddlers (28 days to 23 months), children (2-11 years) and adolescents (12-18 years).
In subsection 4.2, the frequency of administration is written in units of time and is not abbreviated to «1×/day». In subsection 4.3, insufficient data are not in themselves a contraindication, and pregnancy and breastfeeding are listed there only if they are contraindications. In subsection 4.4, a separate risk is described if it requires precautions or a warning to the healthcare professional. The groups of patients for whom the product is contraindicated are listed only in subsection 4.3.
In subsection 4.7, one of four categories of influence on the ability to drive and use machines is given: no or negligible influence, minor, moderate or major influence.
Subsection 4.8 includes reactions for which, after assessment, there is a reasonable probability of a causal relationship with the product. The subsection is structured as follows: a summary of the safety profile, a summary of adverse reactions in a table or structured list, a description of selected reactions, and special patient populations and children.
In the table, reactions are grouped by the system organ classes (SOCs) of the Medical Dictionary for Regulatory Activities (MedDRA). Requirements No. 88 contain a list of 27 classes, from «Infections and infestations» to «Product issues». A reaction is assigned to the most appropriate SOC associated with the target organ. Related terms may be gathered in one class: «liver function test abnormal», «hepatitis» and «hepatic encephalopathy» are given in the class «Hepatobiliary disorders».
Within a class, reactions are distributed by frequency categories, and within one category they are listed in order of decreasing seriousness. The category limits are: very common (at least 1/10), common (at least 1/100 but less than 1/10), uncommon (at least 1/1,000 but less than 1/100), rare (at least 1/10,000 but less than 1/1,000), very rare (less than 1/10,000), not known (cannot be estimated from the available data). The «not known» category is permitted in exceptional cases.
A reaction is described by the most appropriate term, as a rule at the Preferred Term level. The abbreviations NEC (not elsewhere classified) and NOS (not otherwise specified) are not permitted in the SmPC, the word order in a term is natural («interstitial pneumonia»), and where a condition has several names, the most widespread is chosen («Churg-Strauss syndrome» instead of «allergic granulomatous angiitis»). Before frequency is determined, clinically related conditions are grouped at the appropriate MedDRA levels: if each patient has one report of dizziness, three types of dizziness at 2% each are recorded as «dizziness» with a frequency of 6% of patients.
Subsection 4.8 does not state that particular reactions have not occurred, does not give data on comparative frequency (except in the cases specified in the section) and does not use wording about general good tolerability («well tolerated», «adverse reactions are generally rare»). It does not point to the absence of confirmation of a causal relationship. The number of spontaneous reports is not given, and the frequency category is not determined from it.
Explicit prohibitions in Requirements No. 88
1. References to pharmacopoeial quality are not permitted for either active substances or excipients. Proprietary names of excipients are also not permitted.
2. Sections 7 and 7.1 do not give a website or an email address that links to a website.
3. The SmPC does not include the warning to store the product out of the reach of children or the phrase «Do not use after the expiry date (end of the storage period)».
4. References to other medicinal products are permitted only if they are a precaution recommended by the authorized body or the product is used under a regimen exclusively together with other products.
How the package leaflet is structured
The PL is prepared on the basis of the SmPC. Requirements No. 88 provide for six sections, and information must be included in each of them: identification data of the product, indications for use, information needed before starting use, recommendations for use, a description of adverse reactions and additional information. The last section includes excipients, a description of the product, its presentation, storage conditions, and the name and address of the registration holder and of the manufacturer responsible for release quality control. The registration holder may change the order of information within the sections.
The PL template has six numbered sections: what the product is and what it is used for; what to know before use; how to use it; possible adverse reactions; storage; pack contents and additional information. The template determines the order of information, and how readable the document is for the patient depends on its design and the layout of the text.
For the language of the leaflet, Requirements No. 88 require avoiding complex wording and medical terminology and using a conversational style of the official language, short sentences and/or bullet points. Medical terms are put into language that patients understand: first the lay description, then the term itself. Reactions are grouped by seriousness. As a rule, it is recommended to list them in order of decreasing frequency, and a serious reaction that requires urgent action by the patient is placed at the beginning of the section regardless of frequency. The frequency category is explained in understandable wording, for example «very common: more than 1 in 10 patients».
The technical requirements for formatting are as follows:
The minimum font size for a PL placed in the individual pack is 8 pt, the typeface is Times New Roman without italics, and line spacing is at least 3 mm; for products used for diseases with visual impairment, the font is increased.
Italics and underlining are not used, except for Latin terms.
Full justification of the text is as a rule not permitted.
Headings are set off in bold and/or color, with equal spacing before and after the headings.
Lists of adverse reactions should, where possible, contain no more than five or six items.
Alternative PL formats are permitted: Braille, an audio disc and a large-print leaflet.
A separate PL is as a rule prepared for each strength and each dosage form. Member states may, on an individual basis, permit a combined PL if the required dose is made up of different strengths or changes daily depending on the clinical response. Requirements No. 88 permit combined PLs for different strengths and forms. For a combined PL for several strengths of one form, they set three conditions: the dosing regimen provides at least two options, the information for the strengths is fully identical (apart from a small amount of specific information), and the combined PL does not allow confusion between strengths and does not create a risk of incorrect use. The justification for combining strengths is included in the application.
The PL quality criteria include three process indicators (patient involvement in development, consideration of special groups, completed user testing), seven presentation indicators and seven content indicators. Each indicator is scored 0 or 1 point. Up to 3 bonus points are awarded for good practice (the maximum for one criterion), and the maximum score is 20 points: 10 for presentation and 10 for content. The use of system organ classes to group reactions is scored 0 points.
User testing of the PL
User testing is carried out at the applicant’s discretion.
The applicant or registration holder should provide for it for four groups of products:
1. Products with new active substances or in fundamentally new dosage forms.
2. Products whose dispensing conditions have changed.
3. Products whose current SmPC has had significant new safety information added that substantially changes the indications, restrictions on use or method of administration.
4. Products whose indications have been extended to new patient populations, for example children.
Testing is carried out on a full-color PL mock-up. A text version is not acceptable for this. The success criterion is that 90% of literate adults find the information and 90% of them understand it. For two groups of 10 participants, this is 16 out of 20. A participant may not be included in such testing more often than once in 6 months.
The applicant chooses the methodology. A standard methodology is given in Requirements No. 88, but authorized bodies may not require the use of any particular methodology. Repeat testing is not required if information that does not affect safety information or the patient population is added to the PL (the third and fourth groups of the list), or if the design and layout are changed.
For generic and biosimilar products, test results are as a rule not submitted; a text version of the PL of a product with the same INN that has already been registered in a member state is sufficient. At dossier alignment, results are also not required. However, the authorized body may request them if the application is filed in a member state where the product has not been registered before, or may require testing within a year after dossier alignment under Rules No. 78 for products with a significant risk of incorrect use in outpatient settings. If there are no results, a letter identifying the source of the information from which the PL was prepared is submitted in Module 1. The applicant may request a consultation from the authorized body under Rules No. 78.
If test results are submitted, a brief summary of them is placed in Module 1 in the form specified in Rules No. 78: a description of the product and of the testing carried out, questionnaires, the original and revised versions of the PL, the results and the conclusion.
Texts for originator and generic products
When amending the SmPC and PL, the registration holder of an originator product includes in Module 1 the texts approved in the manufacturer’s country. If that is not possible, the texts of the registration holder’s country are submitted, and if that is not possible either, the texts of another country of the region of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) where the product is registered.
For generic, hybrid and biosimilar products, Requirements No. 88 require three groups of materials. First, the current SmPC and PL of the originator (reference) product in the official language of the country where they were approved, with a translation into Russian. Second, a declaration that there are no differences from those texts other than those identified and justified. Third, a line-by-line comparison, placed side by side on one sheet, that identifies and justifies all differences. Typical differences are the manufacturer, shelf life, excipient composition, insignificant differences in bioavailability or pharmacokinetics, and restrictions provided for by the legislation of the member states on the protection of copyright and related rights. Other differences are permitted if they are scientifically justified. A difference in the presence of a score line that allows a divisible dosage form to be split into equal parts is not always insignificant: it may substantially affect the achievement of the dosing regimen in the SmPC of the reference product.
Experts of the authorized bodies may make corrections to drafts in tracked changes mode. Only agreed complete drafts are approved, and the applicant justifies all changes with scientific medical data, except for editorial corrections.
Table 3. Texts in Module 1 by product type
| Parameter | Originator product | Generic, hybrid or biosimilar product |
|---|---|---|
| Source of the text | SmPC and PL of the manufacturer’s country; if that is not possible, of the registration holder’s country; if that is not possible either, of another country of the ICH region | Current SmPC and PL of the reference product with a translation into Russian |
| Additional documents | None | A declaration and a line-by-line comparison with a justification of the differences |
| Obligation after registration | Respond to a request of the authorized body to correct the texts | Bring the texts into line with changes to the texts of the reference product |
| What makes the dossier incomplete | Failure to meet the requirements for the submission format, the justification of changes and the source of the texts of the manufacturer’s country | Failure to meet the requirements for the submission format, the justification of changes and the submission of the texts of the reference product with a declaration and a comparison |
Table 4. Deadlines after registration of a generic, hybrid or biosimilar product
| Event | Deadline | Who acts |
|---|---|---|
| The SmPC and PL of the reference product have been changed and published in the unified register | 120 working days from the date of publication | The registration holder of the generic, hybrid or biosimilar product amends its SmPC and PL |
| An authorized body has sent a request to correct the texts of the reference product | 5 working days from the date the request is received | The body of the reference state sends the request to the registration holder of the reference product |
| The registration holder of the reference product has received the request | 40 working days from the date of receipt | Files an application to change the dossier or a written justification that the texts do not need to be changed |
| The registration holder of the reference product has submitted a justification | 20 working days from the date the justification is received | The authorized body withdraws or confirms its requirement |
Such a request arises if the regulatory review of the dossier of a generic product shows that the current texts of the reference product do not match up-to-date efficacy and safety data (including conclusions of authorities of third countries) or do not match the texts of the manufacturer’s country or of the registration holder’s country. The regulatory review of the dossier of the generic product is suspended and resumes after the new texts of the reference product are agreed. The request is not treated as a request to the registration holder of the generic product. At initial registration of a generic product, the review is not suspended, and the requirements to submit the texts of the reference product with a declaration and a comparison apply.
Because such a request is possible, the applicant should not group changes to the SmPC and PL of a generic product with other types of changes. If the registration holder of the reference product misses the 40 working days, the provisions of Rules No. 78 on suspension of the registration certificate, its revocation (cancellation), restriction of use or changes to the terms of the certificate apply, and the review of the generic product proceeds without the outdated texts. If the registration holder of the generic product has not made the changes within 120 working days, the authorized body under Rules No. 78 suspends or revokes (cancels) the registration certificate, restricts use or sends a requirement to make the changes within a set period.
Authorized bodies and other persons may initiate a request to change the SmPC and PL of any product registered in a member state. The procedure and deadlines are the same, and the requirement extends to the registration holders of all products registered under Rules No. 78.
What to do
Determine the source of the texts before starting work. For an originator product, prepare the SmPC and PL of the manufacturer’s country; if that is not possible, those of the registration holder’s country; if that is not possible either, those of another country of the ICH region. For a generic, hybrid or biosimilar product, obtain the current SmPC and PL of the reference product with a translation into Russian.
Draw up the draft SmPC using the template and completion instructions from Requirements No. 88. Omit sections 10 and 11 if the product is not a radiopharmaceutical, and check the draft against the prohibitions in the section «Explicit prohibitions in Requirements No. 88». For several strengths of one dosage form, choose a combined SmPC under the rules for different strengths or prepare separate texts.
Draw up the PL on the basis of the SmPC using the template and completion instructions from Requirements No. 88. Replace medical terms with understandable words, group adverse reactions by seriousness, check the font and line spacing, and assess the mock-up against the PL quality criteria.
Decide whether user testing is needed before laying out the final mock-up. Check the product against the four groups of products in the section «User testing of the PL». If testing is carried out, use a full-color mock-up and do not include participants who took such testing less than 6 months ago. If there are no results, prepare a letter for Module 1 identifying the source of the information for the PL. If in doubt, request a consultation from the authorized body under Rules No. 78.
Prepare the submission package and a calendar of deadlines after registration. Submit the drafts as PDF files with searchable text. For a generic, hybrid or biosimilar product, attach a declaration and a line-by-line comparison that justifies the differences, and after registration track publications of the reference texts in the unified register: the registration holder of such a product has 120 working days to make changes. The registration holder of the reference product answers a request of the authorized body within 40 working days.
Regulatory framework:
1. Decision of the Council of the Eurasian Economic Commission No. 88 of 3 November 2016 «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)
2. Decision of the Council of the Eurasian Economic Commission No. 78 of 3 November 2016 «On the Rules for Registration and Regulatory Review of Medicines for Medical Use» (as amended on 26 November 2025)
3. Decision of the Council of the Eurasian Economic Commission No. 84 of 3 November 2016 «On the Procedures for Establishing and Maintaining the Unified Register of Registered Medicines of the Eurasian Economic Union and Information Databases in the Field of the Circulation of Medicines»
4. Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union, approved by Decision of the Council of the Eurasian Economic Commission No. 87 of 3 November 2016 (as amended on 19 May 2022)
5. Decision of the Board of the Eurasian Economic Commission No. 100 of 11 August 2020 «On the Pharmacopoeia of the Eurasian Economic Union» (as amended on 25 June 2024)
6. Decision of the Board of the Eurasian Economic Commission No. 172 of 22 December 2015 «On Approval of the Nomenclature of Dosage Forms» (as amended on 21 November 2023)
7. Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicines» (as amended on 4 August 2026)