Dear Colleagues,

In light of the unfortunate incident and information concerning female patients who, following the administration of botulinum toxin preparations, were hospitalized with symptoms of botulism, the Medical Chamber of Montenegro wishes to draw its members’ attention to the statutory and regulatory provisions governing the performance of minimally invasive non-surgical aesthetic procedures within “anti-age” medicine of the head and neck.

Article 189 of the Law on Health Care (“Official Gazette of Montenegro”, Nos. 91/25, 121/25 and 31/26) stipulates that such procedures may be performed by a healthcare institution that has the appropriate premises, staff and equipment, as well as authorization from the Ministry of Health for the use of a new health technology.

These procedures may be performed by medical doctors and doctors of dental medicine who hold a certificate confirming completion of the relevant training in accordance with a European standard approved by the European Committee for Standardization (CEN), issued by a healthcare institution or another body accredited to provide such training.

More detailed requirements are prescribed by the Rulebook on Detailed Conditions for Performing Minimally Invasive Non-Surgical Aesthetic Procedures of “Anti-Age” Medicine of the Head and Neck (“Official Gazette of Montenegro”, No. 144/25).

The Rulebook covers, among other procedures, the injection of dermal fillers, the use of botulinum toxin for aesthetic purposes and for the treatment of excessive sweating, thread lifting, mesotherapy, lipolysis, the application of platelet-rich plasma, chemical peels, and other prescribed procedures.

For the performance of these procedures, a healthcare institution must employ at least one of the following:

a medical doctor specializing in plastic, reconstructive and aesthetic surgery;

a medical doctor or doctor of dental medicine specializing in maxillofacial surgery; or

a medical doctor specializing in dermatology and venereology.

These procedures may also be performed within a healthcare institution by a medical doctor or doctor of dental medicine who has at least two years of clinical experience following completion of the professional examination, provided that they hold a certificate confirming completion of appropriate training for performing such procedures.

Special requirements apply to hair transplantation. Within a healthcare institution, this procedure may be performed by a medical doctor specializing in plastic, reconstructive and aesthetic surgery, a medical doctor specializing in dermatology and venereology, or a medical doctor specializing in general surgery, provided that the doctor holds a certificate confirming completion of training for hair transplantation procedures.

The Medical Chamber of Montenegro particularly emphasizes that a medical doctor may directly provide the above-mentioned healthcare services only if they hold a valid licence to practise and an official facsimile stamp.

Article 133 of the Law on Health Care expressly prohibits healthcare professionals from performing healthcare activities for which they have not been issued a licence.

Possession of a licence alone is not sufficient. A medical doctor must also meet the specific requirements relating to specialization or clinical experience and the relevant professional training, depending on the procedure being performed.

The procedures in question may be performed exclusively within a registered healthcare institution that meets the prescribed spatial, staffing and technical requirements and holds the relevant authorization issued by the Ministry of Health.

Performing such procedures in beauty salons, other unregistered premises, or outside the healthcare system is not permitted.

PATIENT INFORMATION AND CONSENT TO THE PROCEDURE

Considering that the procedures referred to in Article 189 of the Law are classified as new health technologies, as well as the provisions of Article 188 of the Law concerning the patient’s written consent to the application of new health technologies, the Medical Chamber of Montenegro advises and recommends that, prior to performing any of the above procedures, its members:

explain to the patient, in a clear and understandable manner, the nature of the procedure and the manner in which it will be performed;

inform the patient about the expected results, limitations and possible alternatives;

specifically inform the patient about known risks, adverse effects and possible complications;

provide the patient with an opportunity to ask questions and receive all necessary explanations; and

obtain the patient’s written, voluntary and informed consent before performing the procedure.

The written consent should relate to the specific procedure and should be retained as part of the patient’s medical records.

Obtaining consent does not replace the obligation to meet the requirements prescribed by the Law and the Rulebook, nor does it relieve the doctor of the obligation to act in accordance with the rules of the medical profession, professional ethics and the principle of patient safety.

The Medical Chamber of Montenegro calls upon its members to consistently comply with the above-mentioned regulations and professional standards in order to protect patients’ health and safety and to preserve the reputation and integrity of the medical profession.