Risk management plan (RMP) in the EAEU. What it consists of, when it is submitted and how it is updated
The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union, approved by Decision of the Council of the Eurasian Economic Commission (EEC) of 3 November 2016 No. 87 (hereinafter Decision No. 87), require a risk management plan (RMP) to be submitted for all medicinal products with an application for registration and when the registration dossier is brought into line with Union requirements. Bringing the dossier into line with Union requirements (dossier alignment) is the procedure by which a registered product is moved to Union requirements. Three groups of products are excluded from this requirement.
Federal Law of 12 April 2010 No. 61-FZ «On the Circulation of Medicines» (hereinafter 61-FZ) defines an RMP as a detailed description of pharmacovigilance measures (monitoring of a product’s safety after it reaches the market) aimed at identifying, assessing and preventing or minimizing the risks associated with medicinal products, including an assessment of the effectiveness of these measures. The RMP consists of seven parts. The amount of information in it, especially in Part II, depends on the type of product, its risks and its stage in the life cycle.
Purpose of an RMP and the risks it describes
An RMP describes important identified risks, important potential risks and missing information. An important identified risk is an adverse reaction whose link with the product is confirmed by non-clinical, clinical or epidemiological data or by spontaneous reports and which may affect the benefit-risk balance. An important potential risk may affect this balance after further characterization and confirmation. Missing information is an area in which knowledge of the product’s safety is insufficient: this may be a particular use (for example, long-term use) or specific patient populations. For example, a population may not have been included in clinical trials, and there are no data on it. That does not mean the lack of data should be treated as a safety concern.
The risk management process consists of the safety specification (a characterization of the product’s safety profile with these risks and the missing information), the pharmacovigilance plan (planning of activities to characterize risks and to identify new risks) and the risk minimization plan (planning of activities to minimize the consequences of risks and to evaluate the effectiveness of those activities).
The RMP is needed to define and characterize the safety profile of the product, to set out how that profile can be studied further, and to document the measures for preventing or minimizing risks together with the evaluation of their effectiveness and the fulfillment of the post-registration safety obligations set at registration. The RMP also states the degree of confidence that the efficacy of the product will be the same as in clinical trials.
The risk management system is proportionate to the identified and potential risks and to the need for safety data after registration. The RMP changes throughout the life cycle of the product. New safety concerns are added to it, and as the safety profile is studied, concerns are removed or reclassified. An important potential risk may be removed or reclassified as identified, and an identified risk is removed when it is confirmed that it has been fully characterized and is managed.
What parts an RMP consists of
The RMP is submitted as a single document with all parts, modules and annexes, in a single template, so that the document can be assessed. Part II is divided into modules. This allows the content of individual modules to be reduced for some types of products. If a registration holder has several products with the same active substance, the RMP includes all of them, that is, the RMP is prepared for the active substance.
The RMP begins with an administrative section. It states the date data collection ended, the date of signing and the version number, and the list of parts and modules. For updates it also contains a table of module versions with the date of approval by the registration holder and a comment giving the reason for the update. Confirmation is also required that the RMP has been reviewed and approved by the Qualified Person for Pharmacovigilance (QPPV): a signature or other evidence of approval. When the RMP is submitted as part of the dossier, a statement that this person has reviewed and approved it is enough.
Table 1. The seven parts of an RMP
| Part | What it contains |
|---|---|
| I. Product overview | Administrative information about the RMP and an overview of the product. The information must be current and accurate because it is reflected in the registration certificate |
| II. Safety specification | Eight modules, listed below |
| III. Pharmacovigilance plan | Routine and additional pharmacovigilance activities |
| IV. Plan for post-registration efficacy studies | Efficacy studies imposed by a special obligation or a condition of registration; without special obligations the part may be left blank |
| V. Risk minimization measures, including evaluation of their effectiveness | Routine and additional risk minimization measures and evaluation of their effectiveness |
| VI. Summary of the RMP | A short account of the RMP for the public |
| VII. Annexes | Nine annexes, listed below |
Table 2. The eight modules of Part II
| Module | Title | What the module covers |
|---|---|---|
| CI | Epidemiology of the indications for the target populations | Epidemiology of the indications, differences between regions, risk factors for the disease |
| CII | Non-clinical part | Summary of important non-clinical study data, significant toxic properties |
| CIII | Exposure to the medicinal product in clinical trials | Limitations of the safety data from clinical trials, size and age of the population studied |
| CIV | Populations not studied in clinical trials | Use in populations not studied in clinical trials |
| CV | Post-registration experience of use | Post-registration use data, cumulative data |
| CVI | Additional requirements for the safety specification | Assessment of the potential for incorrect use of the product |
| CVII | Identified and potential risks | Description of each important identified and potential risk and of the missing information |
| CVIII | Summary of safety concerns | A consolidated list of safety concerns |
For each important identified and potential risk, Module CVII states the name, the potential mechanism, the source of evidence and the strength of the evidence, the characteristics of the risk (frequency, seriousness, reversibility, effect on quality of life), risk factors and risk groups, preventability, effect on the benefit-risk balance and impact on public health. For missing information it states the name, the grounds for assuming that the safety profile in this area differs from that of the general target population, and a description of the population for which additional data are needed. A specific assessment is required for a number of aspects of the safety profile, for example the potential for overdose and medication errors. The authorized body may request that the module be supplemented if the registration holder has not provided such an assessment and has not justified why these risks are not important.
Part III contains routine and additional pharmacovigilance activities. The plan is oriented to the safety concerns in Module CVIII and is proportionate to the benefits and risks of the product. If there is doubt whether additional activities are needed, or about their stages and timing, the registration holder consults the authorized body in the scientific advice procedure. Of the routine activities, Part III covers what goes beyond working with reports of adverse reactions and signal detection. Additional activities include non-clinical, clinical and non-interventional studies.
The studies in the pharmacovigilance plan are divided into categories. Category 1 comprises studies imposed as a mandatory condition of registration. Category 2 comprises specific obligations in the context of conditional registration on exceptional terms. Category 3 comprises other studies to investigate a safety concern or to evaluate the effectiveness of risk minimization measures.
Part V contains the measures for reducing, preventing or managing risks (risk minimization measures) and the evaluation of their effectiveness. The measures are divided into routine and additional. Routine measures apply to every product and concern the Summary of Product Characteristics (SmPC) and the package leaflet, labeling, pack sizes and dispensing category. Additional measures are proposed when they are needed for the safe and effective use of the product. Once agreed with the authorized body, they become a condition for obtaining the registration certificate or for keeping the registration status, and the details are submitted in Annex 6 to the RMP. For each safety concern, Part V states the routine measures and, if necessary, additional measures with their objectives, justification and the way their effectiveness will be evaluated. The table of routine and additional measures is part of the same Part.
The RMP summary (Part VI) must be available to the public. It is written in plain language and must be consistent with Modules CVII and CVIII and with Parts III-V. The summary states the name of the product and the purposes of its use, a brief description of the safety concerns and missing information, the routine and additional risk minimization measures and the additional pharmacovigilance activities. The summary is updated when the RMP undergoes important changes. These include new important risks, the addition or removal of additional risk minimization measures and substantial changes to the pharmacovigilance plan.
Table 3. The nine annexes of Part VII
| Annex | Title | Notes |
|---|---|---|
| No. 1 | Electronic version of the RMP | A structured electronic file; not submitted in the dossier; may be left blank |
| No. 2 | Summary data on the studies in the pharmacovigilance plan in tabular form | Planned, ongoing and completed studies of categories 1, 2 and 3 |
| No. 3 | Protocols of the studies in the pharmacovigilance plan | Parts A, B and C: protocols for assessment, requested changes to previously approved protocols, agreed protocols |
| No. 4 | Special forms for follow-up collection of information on adverse reactions | Forms that the registration holder uses to collect additional data on safety concerns |
| No. 5 | Protocols of the studies included in Part IV | References to the protocols of efficacy studies |
| No. 6 | Detailed information on the proposed additional risk minimization measures | Drafts of the materials that make up the additional measures |
| No. 7 | Other supporting data, including reference material | References to the dossier to avoid duplication |
| No. 8 | Overview of changes made to the RMP | A chronological list of substantial changes |
| No. 9 | Information on differences between the RMP in the member states and the current version | Submitted where there are differences |
How the RMP is linked to the modules of the registration dossier
The data in the RMP must be consistent with the other sections of the dossier, and the RMP itself must contain cross-references or links to the relevant sections of the non-clinical and clinical overviews and summaries. If the RMP is submitted as part of the dossier, the correspondence between its parts and the dossier modules is shown in Table 4. It reproduces the table in Decision No. 87.
Table 4. Correspondence between the parts of the RMP and the dossier modules
| RMP part | Dossier modules |
|---|---|
| Part I | 2.3 «Quality overall summary», 3 «Quality» |
| Part II, Module CI | 2.5 «Clinical overview» |
| Part II, Module CII | 2.4 «Non-clinical overview», 2.6 «Summary of pharmacological data», 4 «Non-clinical study reports» |
| Part II, Module CIII | 2.7 «Clinical summary», 5 «Clinical study reports» |
| Part II, Modules CIV and CV | 2.5 «Clinical overview» |
| Part II, Modules CVII and CVIII | 2.5 «Clinical overview», 2.7 «Clinical summary» |
| Parts III, IV and V | 2.5 «Clinical overview», 2.7 «Clinical summary» |
The original table in Decision No. 87 does not list Module CVI or Parts VI and VII, so they are not in Table 4 either.
When and how an RMP is submitted
The RMP is submitted together with a description of the risk management system and the RMP summary. When an application for dossier alignment is filed, an RMP is not required for the following products:
1. A product whose active substance has well-established medicinal use, if all of the following conditions are met: the efficacy and an acceptable degree of safety of the active substance are recognized; at least 10 years have passed since the first systematic and documented use of the substance in the member state that is assessing the application for alignment; and that member state has no RMP at the time of dossier alignment.
2. A herbal medicinal product that meets the criteria for a simplified dossier.
3. A homeopathic medicinal product that meets the criteria for a simplified dossier.
For these products an RMP is still submitted if a new indication is added to the SmPC and the package leaflet, a safety concern has arisen that affects the benefit-risk balance, or additional pharmacovigilance activities or additional risk minimization measures are needed for the product to be used while its benefit exceeds its risk.
After registration, a new RMP or an update of it may be needed at any time in the life cycle of the product. The authorized body may request an RMP when a safety concern affects the benefit-risk balance. An RMP may also be needed when changes are made to the dossier that change the list of safety concerns, add additional pharmacovigilance activities or require risk minimization measures to be changed. Such changes include a change of indications, a new dosage form, a new route of administration and a change in the manufacturing process of biotechnology products.
Where there are concerns about risks that affect the benefit-risk balance, the authorized body may oblige the registration holder to monitor the risk management system and to submit a detailed description of it.
The RMP is submitted as part of the registration dossier as PDF files or in another electronic format determined by the authorized body. It is submitted to the authorized body of the member state in the language set by the Rules for Registration and Regulatory Review. These rules were approved by Decision of the EEC Council of 3 November 2016 No. 78 «On the Rules for Registration and Regulatory Review of Medicines for Medical Use» (hereinafter Decision No. 78).
Which parts of the RMP are needed for different types of products
If a product is submitted for registration with the full content of Modules 1-5 of the dossier, all parts of the RMP are submitted. In other cases the scope is determined by the proportionality of the identified and potential risk and by the need to obtain safety data after registration, and some parts or modules may be omitted if the authorized body sets no other requirements. The minimum requirements for the parts of the RMP for different types of products are given in Table 5. It reproduces the table in Decision No. 87.
Table 5. Minimum requirements for the parts of the RMP at registration
| Type of product | Part I | Part II | Part III | Part IV | Part V | Parts VI and VII |
|---|---|---|---|---|---|---|
| Full content of Modules 1-5 of the dossier | In full | All modules in full | In full | In full | In full | In full |
| Generic | In full | Module CVIII in full. Module CVII is submitted if the reference product has no approved RMP and the RMP summary has not been published on the website of the authorized body. Modules CI-CVI are not submitted | In full | If efficacy studies have been imposed on the reference product | A statement of conformity of the safety information in the SmPC and the package leaflet is permitted | In full |
| Hybrid | In full | Module CVIII in full. Modules CI, CIII and CVII on the proportionality principle, taking into account new safety data and differences from the reference product. Modules CII, CIV, CV and CVI are not submitted | In full | In full | A statement of conformity of the safety information in the SmPC and the package leaflet is permitted | In full |
| Fixed combination with a new active substance | In full | Modules CI-CVI with a more detailed description and assessment of the new active substance. Modules CVII and CVIII in full | In full | In full | In full | In full |
| Fixed combination without a new active substance | In full | Module CVIII in full. Modules CII and CIII on the proportionality principle. Module CVII is submitted if the reference product has no approved RMP and the RMP summary has not been published. Module CI and Modules CIV-CVI are not submitted | In full | If efficacy studies have been imposed on the reference product | A statement of conformity of the safety information in the SmPC and the package leaflet is permitted | In full |
| Product with well-established medicinal use | In full | Modules CVII and CVIII in full. Modules CI-CVI are not submitted | In full | In full | In full | In full |
| Biosimilar | In full | Modules CII-CVIII in full. Module CI is not submitted | In full | In full | In full | In full |
The note to the original table in Decision No. 87 names, for Module CVII of a generic product, the RMP summary of the reference product published on the website of the authorized body. The requirements for a generic product (the list below) also mention the list of safety concerns of the active substance published on the same website.
For a generic product, Decision No. 87 provides as follows:
1. Part I: the same requirements as for a full dossier.
2. Part II depends on the reference product. If the reference product has an RMP, Modules CI-CVII may be omitted. Module CVIII is built from the summary of safety concerns of the reference product. If the registration holder considers that there are grounds to change the list of safety concerns, or a new safety concern has appeared, the justification is given in Module CVII. If the reference product has no RMP but the list of safety concerns of the active substance is published on the website of the authorized body, the requirements are the same, and where several lists are published, the choice is justified in Module CVIII. If there is neither an RMP nor a published list, Modules CVII and CVIII are submitted in full.
3. Part III: under the general requirements for this part.
4. Part IV: may be left blank if no post-registration efficacy study was imposed for the generic product.
5. Part V: if the reference product has no additional risk minimization measures, it is enough to state that the safety information in the SmPC and the package leaflet of the generic product corresponds to that of the reference product. For new risks, risk minimization measures are proposed under the requirements for Part V. If the reference product has additional risk minimization measures, Part V is submitted in full under the general requirements for this part.
6. Part VI: as for a full dossier, to the extent determined by the requirements for the parts for a generic product.
7. Part VII: as for a full dossier. In Annexes 4 and 5 to the RMP the registration holder uses materials brought into line with the corresponding materials of the reference product.
The registration holder of a generic product takes part in studies that the registration holder of the reference product is planning or conducting, when it is important to collect data in a single study.
Table 6. Additional requirements for certain types of products
| Type of product | What is required |
|---|---|
| Hybrid | Module CVII gives a detailed assessment of the differences from the reference product, for example in the active substance, indications, dosage, form or route of administration, with a justification of whether the list of safety concerns of the reference product can be used. The clinical trial data on which the application is based are included in Modules CI and CIII |
| Fixed combination with a new active substance | Modules CI-CVI are prepared with an emphasis on the new active substance |
| Fixed combination without a new active substance | Any or all of the registered products with similar active substances from the combination are treated as the reference product. New information on the combination is given in Modules CII and CIII |
| Product with well-established medicinal use | In Modules CVII and CVIII the registration holder justifies the list of safety concerns, or their absence, on the basis of the scientific medical literature |
| Biological medicine | Assessment of the risk of immunogenicity and of the risk of transmission of infectious agents. The pharmacovigilance plan and the risk minimization measures ensure traceability of the product name and batch |
| Homeopathic and herbal medicine without a simplified dossier | The requirements are determined by the type of application for registration |
| Advanced therapy medicinal product (ATMP: gene therapy products, somatic cell products and tissue engineered products) | Special requirements are agreed with the authorized body before the application is filed, in the scientific advice procedure. The safety specification takes into account special risks, including risks to living donors, cell line transformation and vector transfer |
If an RMP is requested because of a safety concern, the same requirements apply as to the RMP of a generic product whose reference product has no RMP. The authorized body may limit Module CVII to data on the identified concern or require full information on safety concerns. If the registration holder submits an RMP voluntarily, the requirements are determined by the type of registration at the initial submission and by Table 5.
The RMP in the Rules for Registration and Regulatory Review
Decision No. 78 mentions the RMP as part of the dossier and in the registration procedures.
Table 7. The RMP in Decision No. 78
| Question | What is established |
|---|---|
| Place in the dossier | The RMP and the summary of the agreed RMP are submitted in Module 1; the RMP is prepared under the Rules of Good Pharmacovigilance Practice |
| Format and language | The RMP is listed in Module 1 with the proviso «if applicable». The RMP may be in English, with a Russian translation of the summary |
| Generic medicines | «In specific cases a risk management plan may be required» |
| Hybrid medicines | «In certain cases a risk management plan may be required» |
| Biosimilars | The RMP is submitted in Module 1 of the dossier; it contains the safety specification and the pharmacovigilance plan |
| ATMPs | The RMP includes a long-term follow-up strategy |
| Procedures for registration and for confirmation of registration | The summary of the agreed RMP is entered in the unified register «if necessary»; in the draft expert report the authorities of the states of recognition comment on the draft RMP «if necessary» |
| Registration in exceptional cases | Safety proposals are submitted in the form of an RMP |
| Conditional registration | Changes to the product information and to the RMP may be included in the dossier for confirmation of registration |
Decision No. 87 requires an RMP for all medicinal products at registration and at dossier alignment, except the three groups of products named above. For generic and hybrid products, Decision No. 78 says that an RMP may be required «in specific» and «in certain» cases. In the procedures for registration and for confirmation of registration, Decision No. 78 mentions the RMP «if necessary».
How an RMP is updated
The registration holder is responsible for the continuous evaluation of the product’s safety data and for updating the risk management system and the RMP. For products approved on a full dossier, the RMP is reviewed at confirmation of registration (re-registration) 5 years after registration and in the period when the first periodic safety update report (PSUR) is submitted after re-registration. A second review is planned approximately 8-9 years after the registration certificate is obtained.
Every submission of the RMP after the initial submission is made as an update with a version number and a date. This applies both to the full RMP and to a part or module of it.
An update is submitted in the following cases:
1. The list of safety concerns changes, or new additional pharmacovigilance activities or additional risk minimization measures are introduced or those in the plan change substantially, including their removal from the RMP.
2. Following the assessment of data, routine pharmacovigilance activities need to be supplemented, the plan for annual enhanced safety monitoring changes significantly, an additional routine monitoring component is introduced in the SmPC, or the plan for evaluating the effectiveness of risk minimization measures needs updating.
3. The assessment of an emerging safety concern is complete and the new concern is confirmed as an important identified or potential risk.
Each update includes a document with a before-and-after table of the changes made in the latest update and of the changes compared with the current approved version. A product has only one current approved version of the RMP. Differences between member states are described in Annex 9 to the RMP, and where there are several updates during a procedure, the last submitted version is considered the current approved one. An RMP submitted in a procedure is considered approved at its end if all changes have been assessed as acceptable.
After registration, the RMP is submitted in the cases and in the manner of making changes to the dossier, except for an RMP submitted to fulfill other obligations imposed by the authorized body. The procedure for making changes to the dossier is set out in Decision No. 78. Introduction of an RMP requested by the authorized body always requires regulatory review. If a change implements an action requested by the authorized body and requires no new data and no regulatory review (implementation of wording agreed with the body), it is submitted as a Type IAIN variation (a Type IA variation requiring immediate notification). Implementation of changes for which the registration holder submits new data that need regulatory review is submitted as a Type II variation.
If, on its own assessment of a signal, the registration holder concludes that the product information or the RMP must be changed, it files an application to change the conditions of the registration certificate as soon as possible: no later than 3 months after completion of the assessment of a signal assessed as an important risk, and no later than 6 months for adverse reactions and risks that are not considered important.
If, at confirmation of registration, the reference state finds that the registration holder’s obligations have not been fulfilled for objective reasons and the dossier needs to be changed, then after a positive conclusion on confirmation of registration the RMP («if applicable») is updated through the variation procedure. The registration holder initiates this procedure within a period not exceeding 120 working days from the date of the reference state’s request.
The RMP and the PSUR are among the main post-registration pharmacovigilance documents and complement each other. The main aim of the PSUR is a retrospective integrated evaluation of benefit and risk after registration, and the aim of the RMP is prospective management of the benefit-risk balance and planning. If both documents are submitted at the same time, the RMP reflects the conclusion on the safety and efficacy profile made in the PSUR. The information in the documents is consistent, but individual sections may differ in format. If new safety concerns or other data requiring a change to the RMP are found in preparing the PSUR, the RMP update is submitted at the same time as the PSUR, and no separate procedure is needed. If the documents coincide in time but the changes are unrelated, the RMP is submitted as a separate variation.
If two or more procedures requiring an RMP are under way for a product at the same time, a single combined RMP is submitted, with the data separated in Module CIII of Part II. The submission option is discussed with the authorized body before the document is submitted.
The RMP in Russian acts
Under 61-FZ, the body that carries out state registration of medicinal products, at the request of the body of control and supervision in healthcare, provides information on a medicine, including the RMP, including information that constitutes a trade secret.
The Specifics of the circulation of medicines in case of a shortage or the risk of a shortage, approved by Resolution of the Government of the Russian Federation of 5 April 2022 No. 593 (hereinafter the Specifics), require an RMP for biological products. The RMP is attached to the application for state registration. The RMP is attached to the application for permission for temporary circulation together with a translation. For the conclusion on packaging for foreign states, the RMP and the translation are submitted if available. When the registration of a biological product is confirmed, the results of RMP activities are submitted. The Specifics are in force through 31 December 2027.
The form of the expert commission’s conclusion, approved by Order of the Russian Ministry of Health of 24 August 2017 No. 558n, provides for an assessment of the RMP for biological products.
What to do
Determine the scope of the RMP by product type. For a product with a full dossier, prepare all parts; for generic, hybrid, combination, biological and other types use Tables 5 and 6 and the requirements for a generic product. At dossier alignment, check whether the product belongs to the three groups for which an RMP is not required and whether there are grounds on which an RMP is submitted anyway. Build RMP preparation into the filing schedule: Decision No. 87 requires an RMP for all products except these groups. The wording «in specific cases» and «in certain cases» for generic and hybrid products is in Decision No. 78.
Check the RMP against the dossier and complete the administrative section. The data in the RMP must be consistent with the other sections of the dossier; check the correspondence of the parts to the modules against Table 4. In the administrative section state the date data collection ended, the date of signing, the version number, the list of parts and modules and the confirmation by the Qualified Person for Pharmacovigilance. Keep records and versions: the registration holder is responsible for the quality of the RMP, and pharmacovigilance inspectors may check the records and versions.
Draw up a review schedule. Include the review at confirmation of registration 5 years after registration, the review in the period of the first PSUR after re-registration, the deadline for filing an application for a change after signal assessment (3 or 6 months), and updates in the three cases in which an update is submitted. Prepare a before-and-after table for each update.
Set up additional risk minimization measures as a program. It describes the justification, objectives, chosen measures, implementation plan and evaluation plan. The full materials of the measures are attached in Annex 6 to the RMP, and the evaluation of their effectiveness is given in Part V. After agreement with the authorized body these measures become a condition of the registration certificate.
For a biological product registered under the Specifics, prepare the RMP for the application for state registration, and for the application for permission for temporary circulation the RMP and its translation. For confirmation of registration, prepare the results of RMP activities. Check the deadline: the Specifics are in force through 31 December 2027.
Regulatory framework:
1. Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 87 «On Approval of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union» (as amended on 19 May 2022)
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)
4. Resolution of the Government of the Russian Federation of 5 April 2022 No. 593 «On the Specifics of the Circulation of Medicines for Medical Use in the Event of a Shortage or the Risk of a Shortage of Medicinal Products in Connection with the Introduction of Restrictive Economic Measures against the Russian Federation» (as amended on 10 August 2026)
5. Order of the Russian Ministry of Health of 24 August 2017 No. 558n «On Approval of the Rules for the Regulatory Review of Medicines for Medical Use and the Specifics of the Regulatory Review of Certain Types of Medicinal Products for Medical Use (Reference Medicinal Products, Generic Medicinal Products, Biological Medicinal Products, Biosimilar Medicinal Products (Biosimilars), Homeopathic Medicinal Products, Herbal Medicinal Products, Combinations of Medicinal Products), and the Forms of Conclusions of the Expert Commission» (as amended on 31 March 2025)