Registration of Food Supplements and FSMP in Romania
A Practical Guide for Manufacturers and Distributors

The apparent simplicity of EU market entry can be misleading. Romania has national procedures, different receiving authorities and different document mechanics for food supplements and FSMP. This guide translates the Romanian route into an operational checklist, while distinguishing statutory requirements from administrative details that must be confirmed before submission.

Status and verification note: This article reflects the legal and administrative position described in the source material as of July 2026. The legal framework comprises Romanian Law No 56/2021, Regulation (EU) No 609/2013, Commission Delegated Regulation (EU) 2016/128 and Romanian Order No 820/2019. Contact points, forms and the manner in which authorities apply the rules may change. The current route should be confirmed with the competent INSP, Ministry of Health or CRSP office before dispatching a dossier.

1. Start with classification: two regimes, two workflows

Food supplements are regulated nationally by Law No 56/2021 on food supplements, published in the Monitorul Oficial No 332 of 1 April 2021. The route described in that law requires a notification certificate (certificat de notificare) before placing the product on the Romanian market. The responsible national framework is the Ministry of Health, acting through specialised structures.

Food for special medical purposes (FSMP) is regulated within the EU framework for food intended for specific groups, principally Regulation (EU) No 609/2013 and Commission Delegated Regulation (EU) 2016/128. Romanian Order No 820/2019 sets out the national notification route described in the source material. The receiving authority is the National Institute of Public Health (INSP), and the route is electronic.

The two categories should not be treated interchangeably. A product presented as FSMP must satisfy the FSMP definition, compositional rules, intended-use requirements and conditions of medical supervision. A food supplement cannot be moved onto the FSMP route merely because that route appears administratively simpler.

flowchart TD
    A[Product planned for Romania] --> B{Correct classification?}
    B -->|Food supplement| C[Apply Law 56/2021 route]
    B -->|FSMP| D[Apply Reg. 609/2013 + 2016/128]
    C --> E{Composition and competent CRSP}
    E --> F[Prepare two physical dossiers]
    F --> G[Submit to CRSP and obtain notification certificate]
    D --> H[Prepare declarations per Order 820/2019]
    H --> I[Electronic notification to INSP]
    G --> J[Market entry only after required certificate]
    I --> K[Respond to any INSP query within the procedure]
    K --> L[Market entry after completion of FSMP route]

2. Food supplements: select the correct CRSP

Romania does not operate a single universal receiving office for food supplements. The competent Regional Centre of Public Health (CRSP) is selected on the basis of the product's composition. The routing below reflects the source material and should be confirmed with the intended centre before dispatch.

1. Vitamins and/or minerals only: the described route runs through CRSP Craiova or CRSP Galați.
2. Vitamins or minerals combined with other substances of nutritional or physiological effect: the described route runs through CRSP Iași, CRSP Cluj-Napoca or CRSP Timișoara. Examples include botanical extracts, enzymes, probiotics and prebiotics.
3. Other substances of nutritional or physiological effect only: the source material treats products without vitamins and minerals but containing substances from this broader group as falling within the same CRSP Iași/Cluj-Napoca/Timișoara route.
4. Medicinal and aromatic plants or bee products under a separate statutory category: historical materials refer to SNPMAPS at IBA Bucharest. The source material states that SNPMAPS ceased accepting notifications for food supplements covered by Law 56/2021 in April 2021. Older online guides presenting SNPMAPS as a general route for contemporary botanical supplements should not be relied upon.

Practical safeguard: For a mixed or unusual formula, send an email or call the proposed CRSP before finalising the dossier. A routing dispute may result in the entire physical documentation being returned and the market-entry timeline being delayed.

CRSP contact details provided in the current source material

• CRSP Cluj-Napoca: str. Pasteur nr. 6, 400349 Cluj-Napoca, Cluj; +40 264 594252 ext. 107; secretariat.cluj@insp.gov.ro.
• CRSP Iași: str. Victor Babeș nr. 14, 700465 Iași, Iași; +40 232 410399 / +40 232 410512; crsp.iasi@insp.gov.ro.
• CRSP Timișoara: bd. Victor Babeș nr. 16, 300226 Timișoara, Timiș; +40 256 492101; crsp.timisoara@insp.gov.ro.

For CRSP Craiova and Galați, current contact details published by the Ministry of Health should be used rather than copying an address from an older consultant checklist. The same principle applies to all email addresses listed above: verify them before sending confidential product documentation.

3. Mutual recognition: a simplified route for products already notified in the EU/EEA

Article 6 of Law No 56/2021 provides a simplified route for a food supplement already lawfully notified in another EU or EEA Member State. The applicant submits a Romanian notification to the competent authority together with the product labelling and evidence that the product is lawfully marketed or notified in the reference EU/EEA state.

This is not a blanket exemption from Romanian compliance. The applicant should confirm that the reference product, formula, packaging and intended use correspond to the Romanian product, and retain documentary evidence that the reference notification is valid. Mutual recognition may reduce duplication of substantive assessment, but does not remove the requirement for Romanian-language information or the submission of a Romanian notification.

4. Supplement dossier: compile two identical paper copies

The described source procedure requires a physical dossier in two identical copies. One copy remains with the authority; the second is returned to the applicant upon completion of the procedure, bearing a physical compliance endorsement and the accompanying notification certificate.

Practical dossier checklist:

1. Notification application (cerere de notificare) on the Ministry of Health form.
2. Romanian labelling in electronic form and as a full-format "in folio" printout.
3. Labelling from the primary market, if the product originates from another country.
4. For mutual recognition: evidence of lawful notification or marketing status in the reference EU/EEA state.
5. Full qualitative and quantitative formula, recommended daily serving and product form.
6. Certificates of analysis for the finished product, including relevant physicochemical and microbiological testing.
7. Certificates of analysis for active substances and excipients.
8. GMP certificate or equivalent evidence of the manufacturing facility's quality system.
9. Packaging declaration confirming compliance with food-contact materials legislation.
10. Romanian leaflet or package insert, if the labelling refers to one or it is included with the packaging.
11. Corporate and registration documents of the notifying entity, including identification details and the responsible documentation contact.

The exact list may depend on the product and the authority. It should be treated as a preparatory checklist, not as a guarantee that no additional document will be requested.

Why the supplement route is not a simple email notification

The described two-copy dossier, physical compliance endorsement and original certificates are features of a paper-based process. It should not be assumed that an email with scanned copies will substitute for the required physical documentation. The Romanian electronic single point of contact (PCUe, edirect.e-guvernare.ro) may provide information and register responsible entities, but the source material does not treat it as a channel for submitting a complete supplement dossier.

Courier dispatch with tracking or in-person submission to the competent CRSP should be planned, allowing for delivery time and confirmation. Above all, the product should not be placed on the market before the notification certificate is issued where the law so requires.

5. Product changes and the notification certificate

The source material states that a change to the quality or composition of the product invalidates the certificate and requires a new notification. This has direct management implications: the formula, specifications, labelling and packaging evidence should be frozen before submission, and a change-control policy should be established for any subsequent reformulation.

• Before submission: finalise the formula, specifications, labelling, certificates of analysis and Romanian claims.
• During review: do not make uncontrolled changes to an ingredient, dose, form or manufacturing facility.
• After certification: assess every change with the competent authority before manufacturing a batch for the Romanian market.

6. FSMP: a separate electronic route through INSP

For FSMP, the described procedure is based on Order of the Minister of Health No 820/2019. The product may be placed on the Romanian market only after notification to INSP, and the notification is described as electronic. The current source identifies alimentespeciale@insp.gov.ro as the dedicated email address. As government mailboxes and submission instructions may change, the address should be verified with INSP before dispatching the dossier.

The route is operationally distinct from the supplement route:

• two physical copies are not described;
• a physical compliance stamp is not described;
• documentation is sent electronically to INSP;
• INSP may request additional documents within 30 days for the purpose of assessing compliance with Commission Delegated Regulation (EU) 2016/128.

The source material also describes the notification as a one-time submission valid for all economic operators selling the same notified product in Romania. Manufacturers and distributors should retain the notification correspondence and confirm that each operator relies on the same product, formula and Romanian labelling.

FSMP document package

1. Labelling for the Romanian market and original labelling, if the product originates from another country.
2. Declaration of conformity of the product manufactured and placed on the market, following the model in Annex 1 to Order No 820/2019.
3. Declaration that the information and data provided are true, following the model in Annex 2.
4. Additional materials requested by INSP, potentially including the full formula, nutritional values, classification justification, intended medical purpose and target population.

Declaration pitfall: The source material identifies wording in the model declaration stating that the product has not been registered in another country as an OTC medicine or food supplement. Before signing, an inventory of the product's regulatory status in each country and market should be carried out, and any conflict should be clarified with INSP before the declaration is submitted.

7. FSMP labelling: classification and medical supervision must be visible

In Romanian, the FSMP label must include the mandatory information required by Commission Delegated Regulation (EU) 2016/128. The source material highlights:

• a statement that the product must be used under medical supervision;
• the disease, disorder or medical condition for which it is intended;
• warnings and information relevant to the target population;
• whether it is suitable as a sole source of nutrition.

The FSMP label should not be used as a marketing shortcut for a food supplement. The product category, intended medical purpose, composition, labelling and dossier must tell the same story. The source material states that compliant products are published after notification on the Ministry of Health list; the current list and its publication status should be checked as part of the pre-launch review.

flowchart LR
    S[Food supplement] --> S1[Composition review]
    S1 --> S2[CRSP selection]
    S2 --> S3[Two paper copies]
    S3 --> S4[Physical submission]
    S4 --> S5[Notification certificate]
    S5 --> S6[Market entry]
    F[FSMP] --> F1[Review Reg. 609/2013 and 2016/128]
    F1 --> F2[Declarations per Order 820/2019]
    F2 --> F3[Email notification to INSP]
    F3 --> F4[Possible query within 30 days]
    F4 --> F5[Completion of notification route]
    F5 --> F6[Market entry]

8. Advertising and health claims: notification is not the end of compliance

Obtaining a supplement notification certificate does not automatically approve every marketing communication. The source material states that advertising of food supplements requires prior approval (avizare) from the competent authority, and that commercial messages must remain consistent with the labelling and package insert approved during the notification process.

Health claims on labels, leaflets and promotional materials are subject to a described separate registration step on the Ministry of Health platform. Supplement notification, advertising approval and health claims procedures should be planned as separate gateways, rather than assuming that one automatically satisfies the others.

9. Seven-step pre-launch checklist

1. Classify the product. Determine whether the formula and intended use justify classification as a food supplement or FSMP under applicable EU and Romanian law.
2. Map the authority. For a food supplement, send the composition to the proposed CRSP and obtain confirmation of competence. For FSMP, confirm the current INSP channel and forms.
3. Freeze the evidence set. Finalise the formula, specifications, certificates, GMP evidence, labelling, leaflet and intended claims.
4. Audit status in other markets. This is critical for mutual recognition and for the FSMP declaration regarding OTC medicines and food supplements in other countries.
5. Prepare the correct medium. Food supplements require the described two-copy paper dossier; FSMP require the described electronic submission and declarations.
6. Set market-entry gates. No supplement on the market before the required certificate; no FSMP on the market before the applicable notification route is completed.
7. Monitor post-launch. Track formula and labelling changes, advertising approval, health claims status, authority guidance and current public lists.

10. Key takeaways for manufacturers and distributors

• Romania has separate practical workflows for food supplements and FSMP.
• For food supplements, composition determines the likely CRSP route; older SNPMAPS guidance should not be automatically applied to products covered by Law 56/2021.
• The supplement dossier is described as physical, in two identical copies, and the notification certificate is a condition of market entry.
• Mutual recognition under Article 6 may simplify supplement submission where a valid EU/EEA notification exists and corresponding product evidence is available.
• FSMP notification is described as electronic through INSP and valid on a one-time basis for operators selling the same notified product.
• The FSMP declaration requires particular care where the product carries different classifications in different countries.
• Contact details and administrative practice are time-sensitive: they should be verified directly before submission.

Sources and verification points

The legal starting points for this article are Law No 56/2021, Regulation (EU) No 609/2013, Commission Delegated Regulation (EU) 2016/128 and the Romanian Ministry of Health and INSP websites. The listed CRSP addresses, the SNPMAPS transition, the dedicated FSMP mailbox and the exact forms should be checked against current official communications directly before a specific submission.

Disclaimer: This article is for informational and educational purposes only. It does not constitute legal or regulatory advice and does not substitute for a product-specific assessment by a Romanian food law lawyer or direct confirmation from the competent authority. It reflects the position described in the source material as of July 2026; administrative practice, contact details and published forms may change.