How the EAEU Resolved the Registration Gap for Medicinal Products Bundled with Medical Devices
Nasal sprays with applicator nozzles, syrups with measuring spoons, injection solutions bundled with syringes. Millions of packages sit on pharmacy shelves, and in almost every one there is something more than just the dosage form itself.
Until 2025, companies bringing such products to the Eurasian Economic Union (EAEU) market operated under conditions of partial uncertainty. While the procedure for making changes was regulated, the fundamental question remained without a clear answer: is it necessary to register a measuring spoon separately as a medical device (MD)? What about the syringe in the kit? What happens to the Registration Certificate (RC) of the medicinal product (MP) if the model of the bundled device changes?
In January 2025, the answers finally arrived. The EAEU Registration Rules received a new section that closes this regulatory gap.
The Situation Prior to 2025
The Rules for the Registration and Examination of Medicinal Products of the EAEU, approved by Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016, originally assumed that a medicinal product package could contain more than just the dosage form. Annex No. 19 to the Rules contained Section B.IV, which described the classification of variations concerning devices and bundled components within a medicinal product package. The procedures were documented and in considerable detail.
However, the basic legal framework was lacking. There were no answers to several fundamental questions: what specific products can be included in a medicinal product package kit? Which of them are classified as medical devices under EAEU law, and which are not? If a bundled syringe falls under the definition of a medical device, must it be registered separately according to the Rules approved by Council Decision No. 46 dated February 12, 2016? And if not, on what legal basis does it circulate on the market?
Companies resolved these issues in different ways. Some viewed measuring devices and applicators as part of the primary or secondary packaging and did not treat them as separate regulatory objects. Others, as a precaution, obtained independent Registration Certificates for the medical devices, incurring additional costs and time losses. Authorized bodies of different Member States interpreted the situation differently, creating risks during mutual recognition procedures.
Changes created a further layer of complexity. A manufacturer wishing to replace a syringe model in the kit could formally find the variation procedure in Annex No. 19, but the legal status of the device itself remained unclear.
Changes Introduced in 2025
The current edition of Council Decision No. 78 contains Section XV, «Special Cases,» with Paragraphs 187 and 187(1), which introduce a three-category classification for all products included in a medicinal product package kit.
Three Categories, Three Regulatory Pathways
Category A. Products within a package that are not classified as medical devices under the acts of the Union bodies governing medical device circulation — cardboard inserts, foil desiccant bags, plastic blister holders. The applicant includes information about such products in the relevant sections of the MP registration dossier in accordance with the requirements of Annex No. 1 to the Rules.
Category B. Products classified as medical devices under the EAEU classification but not intended for sale separately from the medicinal product within the customs territory of the Union. Examples include a syringe and needle designed for a specific dosage form, or a measuring cup compatible only with one particular product.
Under the new rules, such products are not subject to mandatory registration as independent medical devices. In the MP registration dossier, the applicant provides information about the device in accordance with Annex No. 1. The registration of the medicinal product covers all components of the release form, including such a device. Any changes regarding the device are processed through Section IX of the Rules, using standard variation procedures.
Category C. Products classified as medical devices that have undergone registration as an independent medical device under Council Decision No. 46 or the legislation of a Member State and are permitted to be sold separately from medicinal products. In this case, the MP registration dossier must contain a copy of the Medical Device Registration Certificate, along with information per Annex No. 1. All changes are submitted through Section IX of the Rules.
| Parameter | Category A | Category B | Category C |
|---|---|---|---|
| Status under EAEU Law | non-medical device | Medical Device | Medical Device |
| Separate Sale | Not applicable | Not permitted | Permitted |
| Separate MD Registration Required | No | No | Yes (already obtained) |
| MP Dossier Requirements | Information per Annex No. 1 | Information per Annex No. 1 | Copy of MD RC + information per Annex No. 1 |
| Variations | Section IX of the Rules | Section IX of the Rules | Section IX of the Rules |
Regulation of Variations
Annex No. 19 to the Rules, Section B.IV, establishes a differentiated procedure for variations concerning medical devices or other products within a package.
If a device that is not part of the primary packaging is replaced or added — provided it is registered under Decision No. 46, under Member State legislation, or is authorized for circulation in third countries — a Type IA notification procedure is sufficient when three conditions are met: the device accurately measures the required dose, it is compatible with the preparation, and the change does not lead to a significant revision of the medicinal product information.
A device capable of significantly affecting the delivery of the active substance — such as a spacer for a metered-dose inhaler or a nebulizer — requires a Type II major variation, which involves expert examination. Replacing or adding a device that forms part of the primary packaging also requires a Type II procedure. Furthermore, if such a change results in the creation of a new dosage form, an application for a registration extension must be submitted rather than a variation.
Practical Implications
The most significant result of the new norms is the position on Category B. Before 2025, companies launching medicinal products bundled with administration devices faced the risk of a double regulatory burden: obtaining an RC for the medicinal product itself, plus a separate registration for the medical device under Decision No. 46. It is now established that if a bundled medical device is not intended for independent sale, it does not need to be registered separately. Proper reflection in the MP dossier is sufficient.
For Category C, the rules have codified already existing practice. Companies that included an independently registered medical device in a kit received confirmation of the legality of this approach. A copy of the MD Registration Certificate in the MP dossier is now a clear requirement rather than a matter of discretion.
Regarding variations, the rules eliminate yet another area of uncertainty. Regardless of device category, all changes affecting bundled products are processed through Section IX of the Rules. The legal basis for this is now explicitly anchored in the text.
Recommendations for Companies
Conduct a portfolio audit. Compile a list of all medicinal products whose release forms include anything beyond the dosage form itself: measuring devices, applicators, syringes, needles, adapters. For each product, document what is included in the kit and the function of the component.
Determine the category of each device. Address two questions: Is it classified as a medical device under EAEU law, and can it be sold separately from the medicinal product? Assign each device Category A, B, or C according to Paragraph 187 of the Registration Rules. In ambiguous cases — for example, when a device is theoretically compatible with other preparations — it is advisable to document the position in a written legal analysis.
Verify dossier completeness. For every active Registration Certificate, confirm that the dossier contains information per Annex No. 1 for the relevant device. For Category C devices, verify that an up-to-date copy of the Medical Device Registration Certificate is present. If the MD Registration Certificate has been reissued or updated, the copy must be submitted as a variation to the MP dossier.
Review planned device changes. If a replacement of a bundled device model is planned within the coming year, determine the procedure in advance: Type IA notification or Type II major variation. The central question is whether the change affects the delivery of the active substance. For inhalation systems, where any device change may affect aerosol characteristics, this requires a separate technical assessment.
Integrate device categorization into the development SOP. Medicinal products planned for release in kits with devices should undergo categorization under Paragraph 187 of the Rules during the dossier preparation stage. This prevents late-stage revisions.
Open Questions
The Rules have closed the main gap, but several questions remain at the level of enforcement practice.
The first concerns the boundary between Categories B and C. What does «not intended for separate sale» mean in practice? Is a statement on device labeling sufficient, or must there be a technical incompatibility with other preparations? The answer will emerge through inquiries to the EEC and the practice of expert organizations.
The second concerns the scope of information required under Annex No. 1 for medical devices. The text of the Rules references this Annex, but the specific list of device information to be included in the MP dossier is not normatively detailed for Categories A and B. A useful reference point is Section 6.2 of the expert report form (Annex No. 8 to the Rules), which provides a dedicated assessment block for issues involving medical devices.
The third concerns high-tech medicinal products containing medical devices. For these, the Rules contain a separate Section 17.3.4 with more extensive requirements. Companies working with combined high-tech medicinal products — cell or gene therapy in combination with medical devices — must apply both sets of provisions: Section XV and Section 17.3.4 of Annex No. 1.
The Rules have given the industry what it has long lacked: a clear, three-position classification in place of regulatory ambiguity. The question is no longer «what should we do?» but «which category does my device fall into?» — and that is a question with a concrete answer.
Regulatory References
1. Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016, «On the Rules for the Registration and Examination of Medicinal Products for Human Use» (as amended November 26, 2025) — Paragraphs 187, 187(1) of Section XV «Special Cases»; Section B.IV of Annex No. 19; Section 17.3.4 of Annex No. 1; Section 6.2 of Annex No. 8.
2. Decision of the Council of the Eurasian Economic Commission No. 12 dated January 22, 2025, «On Amending the Rules for the Registration and Examination of Medicinal Products for Human Use» — introduced Paragraphs 187 and 187(1) in the current edition.
3. Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016, «On Approval of the Rules for Registration and Examination of the Safety, Quality and Efficacy of Medical Devices.»