Registering Food Supplements and FSMPs in Romania
A practical guide for manufacturers and distributors

The apparent simplicity of entering an EU market can be misleading. Romania has national procedures, different receiving bodies and different document mechanics for supplements and FSMPs. This guide translates the supplied Romanian route into an operational checklist while distinguishing statutory requirements from administrative details that must be reconfirmed before filing.

Status and verification note: This article reflects the legal and administrative position described in the source material as at July 2026. The legal framework includes Romanian Law no. 56/2021, Regulation (EU) No 609/2013, Delegated Regulation (EU) 2016/128 and Romanian Order no. 820/2019. Contact points, forms and the way authorities apply the rules can change. Before sending a dossier, confirm the current route with the relevant INSP, Ministry of Health or CRSP office.

1. Start with classification: two regimes, two workflows

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

Foods for special medical purposes (FSMPs) are regulated under the EU framework for foods intended for particular nutritional uses, principally Regulation (EU) 609/2013 and Delegated Regulation (EU) 2016/128. Romanian Order no. 820/2019 provides the national notification route described in the source material. The receiving body is the National Institute of Public Health (INSP), and the route is electronic.

Do not treat the two categories as interchangeable. A product presented as an FSMP must satisfy the FSMP definition, compositional rules, intended-use requirements and medical-supervision conditions. A supplement cannot be moved into the FSMP route merely because that route appears administratively easier.

flowchart TD
    A[Product planned for Romania] --> B{Correct classification?}
    B -->|Food supplement| C[Apply Law 56/2021 route]
    B -->|FSMP| D[Apply Regulation 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 Order 820/2019 declarations]
    H --> I[Electronic notification to INSP]
    G --> J[Launch only after required certificate]
    I --> K[Respond to any INSP request within the procedure]
    K --> L[Launch when the FSMP route is complete]

2. Food supplements: select the competent CRSP

Romania does not use one universal receiving desk for supplements. The competent Regional Centre for Public Health (CRSP) is selected by reference to the product's composition. The following routing reflects the source material and should be confirmed with the intended centre before dispatch.

1. Only vitamins and/or minerals: the described route is through CRSP Craiova or CRSP Galați.
2. Vitamins or minerals combined with other substances of nutritional or physiological effect: the described route is through CRSP Iași, CRSP Cluj-Napoca or CRSP Timișoara. Examples include botanical extracts, enzymes, probiotics and prebiotics.
3. Only other substances of nutritional or physiological effect: the source material treats products with no vitamins or minerals but with ingredients in this wider group as belonging to the same CRSP Iași/Cluj-Napoca/Timișoara route.
4. Medicinal and aromatic plants or bee products in the separate statutory category: historical materials refer to SNPMAPS at IBA Bucharest. The source material states that SNPMAPS stopped accepting notifications for supplements covered by Law 56/2021 in April 2021. Do not rely on older online guides that present SNPMAPS as the general route for modern botanical supplements.

Practical safeguard: For a mixed or unusual formula, email or call the proposed CRSP before assembling the final dossier. A routing disagreement can result in the whole physical submission being returned and the launch timetable slipping.

CRSP contact details stated in the current source material

• CRSP Cluj-Napoca: str. Pasteur nr. 6, 400349 Cluj-Napoca, Cluj; +40 264 594252 ext. 107; [email protected].
• CRSP Iași: str. Victor Babeș nr. 14, 700465 Iași, Iași; +40 232 410399 / +40 232 410512; [email protected].
• CRSP Timișoara: bd. Victor Babeș nr. 16, 300226 Timișoara, Timiș; +40 256 492101; [email protected].

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

3. Mutual recognition: an abbreviated route for products already notified in the EU/EEA

Article 6 of Law no. 56/2021 is described as providing a simplified route for a supplement already legally notified in another EU or EEA state. The applicant submits the Romanian notification to the competent authority together with the product label and evidence that the product is legally marketed or notified in the reference EU/EEA state.

This is not a general exemption from Romanian compliance. The applicant should confirm that the reference product, formula, pack and intended use correspond to the Romanian product, and should retain documentary evidence that the reference notification is valid. Mutual recognition can reduce duplicate substantive assessment, but it does not remove the need for Romanian-language information or a Romanian notification filing.

4. Supplement dossier: build two identical paper copies

The source procedure describes a physical dossier in two identical copies. One copy remains with the authority; the other is returned to the applicant after the procedure, marked with a physical conformity visa and accompanied by the notification certificate.

A practical dossier checklist is:

1. Notification application (cerere de notificare) on the Ministry of Health form.
2. Romanian label artwork in electronic form and as a full-size “in folio” printout.
3. Original-market label where the product comes from another country.
4. For mutual recognition: evidence of the legal notification or marketing status in the EU/EEA reference state.
5. Complete qualitative and quantitative formula, recommended daily serving and product form.
6. Finished-product certificates of analysis, including relevant physicochemical and microbiological testing.
7. Certificates of analysis for active ingredients and excipients.
8. GMP certificate or equivalent quality-system evidence for the manufacturing site.
9. Packaging declaration confirming compliance with food-contact-material rules.
10. Romanian leaflet or prospectus if the label refers to one or one is included in the pack.
11. Corporate and registration documents for the notifying entity, including identity details and the responsible documentation contact.

The exact list can depend on the product and authority. Treat this as a preparation checklist, not as a guarantee that no additional document will be requested.

Why the supplement route is not simply an email notification

The described two-copy dossier, physical conformity visa and original certificates are paper-process features. An email containing scans should not be assumed to replace the required physical submission. The Romanian electronic single contact point (PCUe, edirect.e-guvernare.ro) can provide information and register responsible entities, but the source material does not treat it as the submission channel for the complete supplement dossier.

Plan for a tracked postal delivery or an in-person filing at the competent CRSP, with time for delivery and confirmation. Most importantly, do not place the product on the market before the notification certificate has been issued where the law requires it.

5. Product changes and the notification certificate

The source material states that a change to the product's quality or composition invalidates the certificate and requires a new notification. This has a direct project-management consequence: freeze the formula, specifications, label and packaging evidence before filing, and create a change-control rule for every later reformulation.

• Before filing: reconcile the formula, specifications, label, certificates of analysis and Romanian claims.
• During review: do not make an uncontrolled change to an ingredient, dose, form or manufacturing site.
• After certification: assess every change with the competent authority before manufacturing a Romanian-market batch.

6. FSMPs: a separate electronic route through INSP

For an FSMP, the supplied procedure is based on Order of the Ministry 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 [email protected] as the dedicated email address. Because government mailboxes and submission instructions can change, verify the address with INSP before sending the dossier.

The route is operationally different from the supplement route:

• no two physical copies are described;
• no physical conformity stamp is described;
• the filing is sent electronically to INSP;
• INSP may request further documents within 30 days to assess compliance with Delegated Regulation (EU) 2016/128.

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

FSMP document pack

1. Romanian-market label and original label, if the product originates in another country.
2. Self-declaration of compliance of the produced and marketed product, using the model in Annex 1 to Order no. 820/2019.
3. Self-declaration that the information and data supplied are true, using the model in Annex 2.
4. Additional material requested by INSP, potentially including the complete formula, nutritional values, classification rationale, intended medical purpose and target population.

Declaration trap: The source material identifies wording in the model declaration stating that the product has not been registered in another country as an OTC medicinal product or food supplement. Before signing, complete a country-by-country regulatory status inventory for the product and any relevant local variant. If a conflict exists, obtain written clarification from INSP before making the declaration.

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

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

• the 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 the sole source of nourishment.

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

flowchart LR
    S[Supplement] --> S1[Composition review]
    S1 --> S2[Select CRSP]
    S2 --> S3[Two paper copies]
    S3 --> S4[Physical submission]
    S4 --> S5[Notification certificate]
    S5 --> S6[Market launch]
    F[FSMP] --> F1[Regulation 609/2013 and 2016/128 review]
    F1 --> F2[Order 820/2019 declarations]
    F2 --> F3[Email notification to INSP]
    F3 --> F4[Possible request within 30 days]
    F4 --> F5[Complete notification route]
    F5 --> F6[Market launch]

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

Obtaining a supplement notification certificate does not automatically clear every marketing communication. The source material states that supplement advertising requires prior approval (avizare) by the competent authority and that commercial communications must remain consistent with the label and prospect approved in the notification process.

Health claims on labels, leaflets and promotional materials are described as subject to a separate registration step on the Ministry of Health platform. Plan product notification, advertising approval and health-claim workstreams as separate gates rather than assuming that one automatically completes the others.

9. Seven-step pre-launch checklist

1. Classify the product. Decide whether the formula and intended use support a food supplement or FSMP classification under the applicable EU and Romanian rules.
2. Map the authority. For a supplement, send the composition to the proposed CRSP and obtain confirmation of competence. For an FSMP, confirm the current INSP channel and forms.
3. Freeze the evidence set. Align formula, specifications, certificates, GMP evidence, label, leaflet and intended claims.
4. Audit other-market status. This is essential for mutual recognition and for the FSMP declaration about OTC medicines and food supplements in other countries.
5. Prepare the correct medium. Supplements require the described two-copy paper dossier; FSMPs require the described electronic submission and declarations.
6. Set launch gates. No supplement launch before the required certificate; no FSMP launch before completing the applicable notification route.
7. Monitor after launch. Track formula and label changes, advertising approval, health-claim status, authority guidance and the current public lists.

10. Key takeaways for manufacturers and distributors

• Romania has separate practical workflows for supplements and FSMPs.
• For supplements, composition determines the likely CRSP route; older SNPMAPS guidance should not be applied automatically to products covered by Law 56/2021.
• The supplement dossier is described as physical, in two identical copies, and the notification certificate is a precondition for placing the product on the market.
• Mutual recognition under Article 6 can simplify a supplement filing where a valid EU/EEA notification and matching product evidence exist.
• 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 when the product has different classifications in different countries.
• Contact details and administrative practice are time-sensitive: verify them directly before filing.

Sources and verification points

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

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