Romania’s Complementary Medicine Rules: What Patients Can Check

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In the debate over complementary medicine, the useful question for patients is not whether a practice has a controversial name. It is whether the person providing the service can be identified, explains its limits, and refers the patient for medical care when the situation requires it.

On 25 September 2026, Romania’s Ministry of Health published, for public consultation, a draft order containing methodological rules for implementing Law No. 118/2007. As of 26 September, the document was still a draft under consultation: the order number and date had not been completed in the PDF, and the text provides for subsequent publication in the Official Gazette. It would therefore not have been correct to present it as a rule already in force. Ministry of Health

For more information about the Ministry of Health, see The BCG vaccine after the cancelled tender: what the 36,200 doses mean and how newborns scheduled later will catch up, which provides additional details on this subject.

The document’s significance is less dramatic than the list of practices covered by the law, but more important for the public: the draft seeks to establish the administrative tools that have been missing for years — authorisation, practices, records, consent and oversight.

First, what already existed

Law No. 118/2007, published in Official Gazette No. 305 of 8 May 2007, is the basic legal framework for complementary/alternative medicine activities and practices. The law requires the beneficiary’s written consent and accessible information about benefits and risks.

The legislation brings together very different practices. For some of them — including homeopathy, acupuncture, apitherapy, phytotherapy, chiropractic, osteopathy and traditional Oriental medicine — the law provides for practice by doctors, dentists or pharmacists, under the conditions established by law.

The law also provided for practitioners to be authorised after the methodological rules entered into force. The Ministry’s explanatory memorandum states that the absence of these rules prevented the procedures for authorisation, the single register, and a unified mechanism for records and oversight from becoming operational. Explanatory memorandum

What the draft under consultation would add

The draft does not medically reassess every practice in the annex to the law. It proposes the administrative process through which the activity would be organised and supervised.

A licence to practise would be issued by the Ministry of Health, with the approval of the National Institute for Health Services Management (INMSS).
The application file would include documents on relevant training, a criminal-record certificate, a health certificate and the opinion of the proposed professional organisation.
Practices would be subject to rules on health authorisation, operating conditions and record-keeping.
A single register of practitioners would be established and administered by the Order of Complementary/Alternative Medicine Practitioners (OPMCA), a body provided for by the draft.
The register would have to include the authorised fields, the validity of the authorisation and disciplinary sanctions.

These elements may matter for safety and traceability. However, on the date checked, there was no evidence that the OPMCA was already operating, that the register was operational, or that patients could consult it online. A register mentioned in a draft is not automatically a publicly available tool.

The implementation test: what a patient could actually check

If the rules were adopted and the mechanisms they provide for became operational, assessing a service could begin with four separate questions.

Question	What the proposed framework could show	What it cannot establish on its own
Who provides the service?	The provider’s identity, the field in which they are authorised and, under the draft’s terms, the required professional documents.	Whether the intervention is effective for the patient’s particular problem.
Under what conditions do they work?	The existence of a practice and compliance with applicable administrative and health requirements.	That the premises amount to medical confirmation of the therapy.
What do they explain before the intervention?	A consent form that should state the therapy, estimated duration, risks, contraindications, limits and the right to withdraw.	That every promise made in that document is plausible.
What do they do if the condition worsens?	Compliance with limits of competence and referral to a doctor in the situations provided for.	That the patient can delay necessary medical assessment.

This is the practical difference between oversight and effectiveness: the former can make it easier to trace who is accountable for a service; the latter must be assessed separately for the specific intervention, the specific condition and the type of patient.

What a non-medical provider cannot do under the draft

An important restriction concerns practitioners who are not doctors, dentists or pharmacists. In the version put out for consultation, they could carry out activity only as a complement to, or following, medical therapy, on the basis of a doctor’s written recommendation and with the beneficiary’s written consent.

The draft would prohibit them from establishing diagnoses, making medical recommendations, or changing, replacing or discontinuing prescribed treatment. It would also prohibit the provision of complementary/alternative therapies in medical-surgical emergencies or where immediate medical intervention is necessary.

In the event of adverse reactions, worsening health or practice beyond their competence, the proposed text provides for the beneficiary’s immediate referral to a doctor. For patients, this is a simple precautionary criterion: a request to abandon prescribed treatment or avoid medical consultation is not compatible with the limits described in the draft. Draft order and annex

The current law requires the beneficiary’s written consent. The draft details its content: the proposed therapy, estimated duration, risks, contraindications, limits and the right to withdraw.

Readers should not regard the document as a formality to be signed quickly. It should make it possible to ask some basic questions: what exactly will be done, what risks are known, in which situations the intervention is not appropriate, and what happens if symptoms change or worsen.

Promises of guaranteed cures, the absence of explanations about contraindications, or pressure to give up prescribed care are incompatible with an informed choice. They do not become credible because they appear on a form or in a practice.

Products do not have the same legal status

For the initial stage, the draft limits the category of “remedies” to authorised homeopathic medicines, food supplements and medical devices. These are different legal categories.

Law No. 56/2021 defines food supplements as food products intended to supplement the diet and expressly distinguishes them from medicines. The draft would allow practices to provide informational materials, but not to sell or distribute these products, nor to attribute to them indications for preventing, treating or curing pathologies.

A legal label can show the regulatory framework into which a product falls. It does not, in itself, resolve whether the product is an effective treatment for a particular disease.

Homeopathy is a separate example, not a verdict on all practices

In the case of homeopathy, there are specific assessments that should not automatically be extended to acupuncture, phytotherapy, manual therapies or any other practice covered by Law No. 118/2007.

In April 2026, the Spanish Agency of Medicines and Medical Devices (AEMPS) presented an assessment based on an analysis of 64 systematic reviews. Its stated conclusion was that there is no scientific evidence supporting the effectiveness of homeopathy as a therapeutic tool. AEMPS

The US National Center for Complementary and Integrative Health likewise states that there is little evidence to support homeopathy as an effective treatment for any specific condition, and warns that some products labelled as homeopathic may contain active ingredients in significant amounts, with possible adverse reactions or interactions. NCCIH

These sources concern homeopathy. A responsible analysis of another practice would require its own evidence regarding that practice, the indication for which it is promoted and the relevant risks.

A prudent protocol before paying

Ask for the provider’s details. Their full name, primary profession, relevant qualification and the precise field in which they say they practise are more useful than a generic “therapist” label.
Ask about the intervention’s limits. A responsible answer includes contraindications, risks and the situations in which a doctor should be consulted.
Ask for the documents to be explained. Consent should not be devoid of substance: the therapy, estimated duration, risks and right to withdraw must be understandable.
Do not change prescribed treatment without consulting the doctor responsible for your care. The draft specifically proposes prohibiting non-medical practitioners from changing, replacing or stopping prescribed therapies.
Treat worsening symptoms as a medical issue. Severe symptoms, symptoms that appear suddenly or symptoms that are getting worse require prompt medical assessment.

This protocol neither recommends nor rejects a particular intervention. It helps distinguish between a service that responsibly declares its limits and one that asks for trust without sufficient explanation.

What is actually changing

The 2007 law already exists. What is new in the draft is the attempt to turn the law’s principles into an administrative mechanism involving authorisations, practices, records, consent and possible oversight.

The practical value of the change will depend on the order being adopted and on the effective operation of the institutions, procedures and register provided for by the draft. Patients will still need to ask a separate question that cannot be resolved by an administrative act: what evidence is there that the proposed intervention helps in their medical situation?

Frequently asked questions

Has the order on complementary medicine entered into force?

Not as of 26 September 2026. The Ministry of Health published the draft for public consultation on 25 September 2026. To become applicable, the order would have to be finalised, signed and published in the Official Gazette.

What could a patient check if the draft becomes applicable?

The provider’s identity and field of authorisation, the practice’s documents and conditions, and the content of informed consent could all matter. The single register is provided for in the draft, but should not be considered operational or publicly accessible before it is actually put into operation.

Can a non-medical practitioner ask me to stop prescribed treatment?

Not under the draft put out for consultation. It would prohibit practitioners who are not doctors, dentists or pharmacists from changing, replacing or discontinuing prescribed treatment. Any change in treatment should be discussed with the doctor overseeing it.

Does a notified or regulated product mean it effectively treats a disease?

No. Legal status indicates the framework applicable to a product; it does not automatically demonstrate effectiveness for a specific disease. For example, Law No. 56/2021 defines food supplements as food products, distinct from medicines.

Does the assessment of homeopathy apply to all complementary therapies?

No. The AEMPS and NCCIH conclusions cited in this article concern homeopathy. The effectiveness and risks of other practices must be assessed separately, for each intervention and medical indication.