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Ordinance On Cosmetic Treatment

Original Language Title: Bekendtgørelse om kosmetisk behandling

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Table of Contents
Chapter 1 Definitions and age requirements
Chapter 2 Cosmetic Treatment
Chapter 3 Loading in the treatment facility
Chapter 4 Help!
Chapter 5 Logging of cosmetic treatment
Chapter 6 Informed Consent
Chapter 7 Penalty provisions
Chapter 8 Entry into force

Completion of cosmetic treatment

In accordance with section 18, section 21, section 22, paragraph 22. 3, section 71, paragraph. 2-4 and 6, sections 72 and § 91 of the law on health professionals and on health professional activities, cf. Law Order no. 877 of 4. August 2011, as amended by law no. 519 of 26. May 2014 :

Chapter 1

Definitions and age requirements

§ 1. In the case of cosmetic treatment, in this notice, it is a corrective undertaking in which the cosmetic account is the decisive indication or treatment which is intended to change or improve the appearance of the main purpose.

§ 2. In the case of an operational intervention, this notice is understood to be an intervention which penetrated skin or mucous membranes or tampering with the introduction of apparatus in the natural bodies.

§ 3. Cosmetic treatment must not be carried out on patients under the age of 18.

Paragraph 2. However, cosmetic orthtodonti (dentists) may be carried out on patients under the age of 18.

Chapter 2

Cosmetic Treatment

§ 4. The following treatments must be carried out in cosmetic purposes only by doctors with special medical qualifications in the specialised specialties and documented, relevant qualifications :

1) Evaluation of the patient prior to the transplantation and execution of the patient, cf. However, section 6, no. 1 : Dermato-venerology (skin and genital diseases) or plastic surgery.

2) Skin plastic and expand on the scalps for the correction of baldness, cf. However, section 6, no. 2 : Plastic Surgery.

3) Surgical lifts : plastic surgery.

4) Surgical lift of eyebrow : Oftalmology (eye disease) or plastic surgery.

5) Operative intervention on ears and nose : Oto rhino-laryngology (ear-, nose and straw disease) or plastic surgery.

6) Operative facial and straw, including thread-lift : Plastic Surgery.

7) Operative intervention in the eye region : Oftalmology or plastic surgery.

8) Surgery of implants in the face, plastic surgery.

9) Operative intervention on breasts and the elimination of gynastasthi (rib formation in men) : Plastic-surgery.

10) Operational mavelove : Plastic Surgery.

11) Fedgesuction : Plastic Surgery.

12) Operating on implants in arms, legs and bales, plastic surgery.

13) Surgical lift of arms, legs and bales : plastic surgery.

14) Operative intervention on male reproductive organs : plastic surgery or urology (ny-and urinary diseases).

15) Treatment with autols and filler equivalent to more than 100 ml. : Plastic Surgery.

16) Treatment with autols and filler equivalent to 100 ml and less : Dermato-venerology, or plastic surgery.

17) Treatment with sclerozing injections in smaller vessels : Dermato-venerology, carcasurgical or plastic surgery.

18) Treatment of botulinumtoksin and injections thereof : Dermato-venerology, neurology (neurological system diseases), opthalmology or plastic surgery.

(19) Treatment with permanent fillers : Dermato-venerology or plastic surgery.

20) Treatment with lipolysis : Dermato-venerology or plastic surgery.

21) Treatment with laser polyress : Dermato-venerology, or plastic surgery.

(22) Dermabrasio, Dermato-venerology, or plastic surgery.

23) Non-ablative treatment with laser, class 3B or 4, IPL and other methods that can be equated, as well as its execution : "Dermato-venereology."

24) Ablativeable treatment with laser, class 3B or 4, and other methods that can be equated, as well as their execution : Dermato-venereology.

25) The peeling of the skin with trichloroacetic acid (TCA) and phenol : Dermato-venerology or plastic surgery.

§ 5. Doctors with a right to independent function and with documented, relevant qualifications can, after a concrete assessment of the qualifications, have permission from the Board of Health to make the cosmetic treatments referred to in Section 4.

§ 6. The following treatments must be carried out in cosmetic purposes only by doctors with the right of self-employed personnel to operate and with proven, relevant qualifications :

1) Hairgraft, cf. However, section 4, no. 1.

2) Inclusion of smaller scopes in relation to skin plastics and expansion, which alone requires collating the skin.

3) Treatment with non-permanent fillers.

4) Peeling of the skin with products with a pH of 3 or less, cf. However, section 4, no. 25.

§ 7. Operative and non-operative plastic and porcelain treatments must be carried out in cosmetic purposes only by dentists.

Paragraph 2. Denial bleach with dentists containing 0.1% to 6% hydrogen peroxide must be carried out in cosmetic purposes only by dentists.

Paragraph 3. Dentials with laser, class 3B or 4, and other methods that are to equal treatment must be carried out in cosmetic purposes only by dentists with documented, relevant qualifications.

Chapter 3

Loading in the treatment facility

§ 8. In the case of large and complex cosmetic treatments, including breast lifting, breast-solictable and reduction measures, operating on the stomach, fats and the insertion of implants in the buttocks, the patient shall subsequently be subject to observation on : the processing facility, cf. § 9.

Paragraph 2. In the case of peeling with phenol, the patient shall be subject to an observation at the processing place, cf. § 9.

§ 9. In cosmetic treatment, which requires submission, cf. in Article 8, the processing place must be in such a way as to enable patients to be admitted safely in order to ensure that they are admitted.

Paragraph 2. In the course of the patient's admission to the place of treatment, a doctor shall be carried out with the right to self-employed or nurse, with documented, relevant qualifications in observation of patients after operation.

Paragraph 3. The person responsible for the cosmetic treatment or a deputy doctor with the same qualifications must be able to be called within a reasonable period of time.

Chapter 4

Help!

§ 10. The treatment provided for in section 4 to 7 may not be used with the exception of the forms referred to in paragraph 1. 2 and 3 treatments mentioned.

Paragraph 2. In the case of the following cosmetic treatments, the registered doctor, cf. section 4-7, use the help of the documented, relevant qualifications, but not by examination of the patient and the choice of treatment (silent indication) :

1) Performing a hair transplant, cf. § 4, no. Number one, and section 6, number 1 : Documented, documented, appropriate qualifications.

2) Treatment with sclerozing injections in smaller vessels, cf. § 4, no. 17 : Physician, dentist and nurse with documented, relevant qualifications.

3) Negotiate with botulinumtoksin, cf. § 4, no. 18 : doctor, dentistry and nurse with documented, relevant qualifications.

4) Operative and non-operative plastic and porcelain treatments, cf. Section 7 (2). 1 : Documented, documented, appropriate qualifications.

5) Dental bleaching, cf. Section 7 (2). 2 : Assist with documented, relevant qualifications in accordance with the notice of cosmetic products.

6) Dentiation with lasers and other methods that are to equate with them, cf. Section 7 (2). 3 : Documented assistance with documented, appropriate qualifications.

Paragraph 3. For the following cosmetic treatments, the registered doctor shall use the help of the documented, relevant qualifications, including in examination of the patient and the choice of treatment (silent indication) :

1) Removal of hair and vessels and mild wrinkle treatments with laser, IPL and other methods that may be treated as such, cf. § 4, no. Twenty-three, doctor, dentist and nurse with documented, relevant qualifications.

2) Treatment with not permanent fillers, cf. § 6, nr. 3 : doctors, dentists and nurses with documented, relevant qualifications.

3) Peeling of the skin with products with a pH of 3 or less, cf. § 6, nr. 4 : doctors, dentists and nurse with documented, relevant qualifications.

§ 11. People without it in section 10 (4). 3 mentioned health professional authority, but with documented, relevant qualifications, can, after a practical assessment of the qualifications, get permission from the Board of Health to do so in section 10 (1). 3 mentioned treatments, however, not by examination of the patient and the choice of treatment (silent indication).

§ 12. Using help, cf. § 10 and § 11, the registered doctor, cf. Section 4-7, be associated with the processing place in such a way as to ensure that the undertaking that is carried out on behalf is carried out in accordance with good professional practice and with the law which the doctor is obliged to comply with.

Chapter 5

Logging of cosmetic treatment

§ 13. The Board of Health shall register for cosmetic treatment after application, including those in accordance with section 4 to 6, including those in accordance with section 10 and Section 11, shall be used as their co-aid for this purpose. The Board of Health shall also record which cosmetic treatments, the registered doctor and his co-operation are carried out, and on which therapeutic treatment is carried out.

Paragraph 2. The Board of Health shall assess the qualifications of the persons referred to in sections 4 to 6, section 10 and section 11 of which they are registered.

Paragraph 3. Persons meeting the criteria for the deletion of the Health Management register for cosmetic treatment in accordance with sections 19 and 20 may be denied entry to the Register.

§ 14. Conduct of the cosmetic treatments referred to in sections 4 to 6 and section 11 of the said cosmetic treatment shall be registered to the Board of Health, respectively, to the Board of Health.

Application for registration

§ 15. The application for registration to carry out cosmetic treatment must be made electronically via the Health Management website www.sundhedsstyrelsen.dk and must include information on :

1) the authorization identifier, name, address, number and e-mail of the doctor,

2) the cosmetic treatments the doctor wants to be registered for,

3) the qualification of the doctor, including information on the training and experience of the cosmetic treatment which is being searched,

4) the medical care provided for and the qualifications of the cosmetic treatments, including training in the cosmetic treatment and experience to be carried out by the doctor, shall be required, including training in the cosmetic treatment and experience.

5) Central Business Register Number (CVR-#), production unit number (P-#), name and address,

6) responsible doctor or supervisor responsible doctor at the place of treatment, in which the doctor and his / her, if any, carry out the cosmetic treatment ; and

7) information on medical presence, staffing, medical call, boarding of detention, and the opportunities for the treatment and monitoring of the facilities.

Paragraph 2. Written documentation for the documents referred to in paragraph 1. 1, no. 2 and 4 of this information shall be attached to the application or dispatched.

§ 16. If the Board of Health assesses that an applicant may be registered to carry out the requested cosmetic treatment, the applicant shall receive written notice of the registration and the entry on the registration shall be recorded on the Health Board ' s website, cf. SECTION 26.

Deletion from the procedure for cosmetic treatment

§ 17. Deletion from the register will cause the doctor and his help to make the registered cosmetic treatment no longer subject to the operation of the registered cosmetic procedure. § 13 and section 14.

§ 18. Where the basis for which the doctor or his or his aid was registered, the Board of Health considers that the Board of Health considers that the basis for registration is no longer present, the medical examiner and his assistance from the register shall be deleted, and details of : the doctor shall be deleted from the board's website, cf. SECTION 26.

§ 19. The Board of Health may delete a doctor and his assistance from the register, if the doctor,

1) have been placed under tighter supervision following the health bill, the law of law no. 913 of 13. June, 2010, cf. § 215, paragraph 1. 2,

2) have been issued injuns concerning the subject of a change in professional activity, cf. the law on health professionals and the health professional establishment (approval law) section 7 (4) ; 2,

3) have been reduced by the business area, cf. Authorization Act, section 7 (3). TWO, TWO. pkt.,

4) temporary restrictions have been reduced by the business area, cf. Authorization Act, Section 8 (3). 2, or

5) temporary has been deprived of the authorization, cf. Authorization Act, Section 8 (3). 1.

20. If the registered doctor has not complied with the health services for the professional activities of the clinics, the doctor and his aides are discarded from the register, and details of the doctor are deleted from the Board's website, cf. SECTION 26.

§ 21. If the Health Service does not receive it in section 23, the fee from the registered physician, will be deleted and his help from the register, and information on the doctor is deleted from the Board's website, cf. SECTION 26.

§ 22. Registered doctors who will be discarded from the Health Board ' S register for cosmetic treatment may not require payment fees reimbursed.

Fees

-23. Doctors applying for the registration to carry out cosmetic treatment must, for the registration and then pay a fee of 16.145 DKK annually. (2014 price and pay level) to cover the cost of the unit in relation to the registration scheme. The fee shall be price-paid and paid once a year and be reported by the Board of Health.

Paragraph 2. If the Board of Health assesses that an applicant may not be registered to carry out cosmetic treatment, the applicant shall receive written notification from the Management Board. The applicant shall receive any registration fee as provided for in paragraph 1. 1 reimbursed.

§ 24. Payment of it in section 23 (1). 1 that is due to be due annually in December.

Paragraph 2. If the Board of Health does not, within any of the Management Board, set the payment date in section 23 (4). 1 the charge from the registered doctor may be recovered by the restency authority in accordance with the rules on the subject of the Law No 1. 1333 of 19. December 2008 on debt recovery for the public sector.

§ 25. In exceptional cases, the Board of Health may derogate from the annual fee.

Publication

SECTION 26. The Health Services Board shall regularly publish on its website www.sundhedsstyrelsen.dk information about which doctors are registered to make cosmetic treatment, what cosmetic treatments they are registered to make, which others, authorised health professionals who, as the doctor's help, are registered to make cosmetic treatments and what treatments they may carry out, as well as the treatment facility which the cosmetic treatment takes place.

Paragraph 2. The Board of Health may, on its website www.sundhedsstyrelsen.dk, publish information on the results of the supervision of the cosmetic activities of each of the registered doctors and the processing facility, where the cosmetic treatment is carried out, including : report on the supervision of the Board of Health.

Paragraph 3. The medical examiner shall publish the report of the Health Board in respect of the latest surveillance easily available on the site ' s website and immediately available at the processing site at the same time as the surveillance report has been published ; in the health management website, cf. paragraph This is also true in cases where the last inspection has been carried out before the date of the notice.

Paragraph 4. The registered doctor must be clearly at the home page of the office or clinics where the doctor is registered, illus on this registration.

Chapter 6

Informed Consent

Information

§ 27. A patient must have adequate information on the cosmetic treatment that the person in question wants to make.

Paragraph 2. The information must be given to the competent health experts of the cosmetic treatment for the cosmetic treatment.

Paragraph 3. The information must be given in writing and orally. The oral information must be given in accordance with written information and to take account of the written information and take account of the needs of each patient.

Paragraph 4. The information must contain an understandable representation of the cosmetic treatment without the use of technical, professional or value-made terms. The information must be neutral rather than unobjectively highlighting or favouring a treatment method rather than another.

Paragraph 5. The information must be given in a sensitive manner and be tailored to the individual premier of the consignon with regard to age, maturity, experience, etc.

§ 28. Cosmetic treatment must not be carried out on patients who have dissent information about treatment.

Contents of information

§ 29. The written information shall contain an adequate production of the intended cosmetic treatment. The information must be more comprehensive in the run-down of treatment, and when treatment leads to serious complications and adverse reactions.

Paragraph 2. The information must include information on :

1) the realistic, expected result of the cosmetic treatment,

2) the type and frequency of complications and adverse reactions in relation to the cosmetic treatment and treatment thereof ; and

3) any possible senses and long-term comments and / or side effects of the cosmetic treatment.

Paragraph 3. The patient, in fact, is not aware of circumstances that affect the position of the patient, the patient who is responsible for processing responsible health experts in particular must be informed of the relevant medical information.

-$30. Patients who have implanted implants shall in the course of processing have delivered written information on the location of the implant in the body, the name of the implant, the size of the implant, the size of the implant and the manufacturer ' s name. After processing, the patient must have provided serial number or lot followed by batch code.

§ 31. Deviges the intended cosmetic treatment from the method or commonly accepted methods in relation to the treatment, the competent health expert responsible for processing must, in particular, provide information on it, including the reasons for which a person is offered ; method other than the accepted or commonly accepted procedure.

§ 32. If the competent health expert has a limited experience with the cosmetic treatment in question, the patient must be informed of it.

Paragraph 2. The person responsible for processing responsible authorised health experts shall indicate its own findings, including the complications and so on.

Paragraph 3. The health expert who is responsible for processing shall indicate on the results of the cosmetic supervision of the Health Service with the health care staff and the treatment facility in question, cf. Section 26 (1). 2.

§ 33. The written information shall indicate that consent may only be submitted after the expiry of the period of reflection, cf. § 34, and that the patient has the right to bring a bee-sitting at the reception of the oral information.

Thoughtful time

§ 34. In the case of major cosmetic treatments, including operational intervention in breasts, operating air of tummy and fatty suction, the patient shall have a week of reflection from the oral information received for the consent of the oral information.

Paragraph 2. In the case of minor cosmetic treatments, including minor hair transplants, treatment of botulinumtoxin and peeling of the skin, the patient must have two days of reflection from the oral information received for their consent.

Paragraph 3. In the case of peeling of the skin with products with a pH of 3 or less, and the removal of hair and vessels and non-abulative (mild) wrinkle treatments with lasers, IPL and other methods that can be treated as such, the patient may consent to the treatment of the hair and the non-abulative (s), and the same when the oral information is provided.

Samthick

$35. A cosmetic treatment must not be initiated or continued without the informed consent of the patient.

Paragraph 2. In the informed consent of this notice, the consent given on the basis of written and oral information shall be understood as provided for in written and oral information. § § 29-32.

Paragraph 3. The consent must be specific and must be given shortly after the expiry of the period of reflection, cf. § 34. The consent must be given for the taking of a cosmetic treatment in the immediate future (be topical).

Paragraph 4. The patient may, at any time, revoke his consent in accordance with paragraph 1. 1.

Journaling and so on.

§ 36. The patient record shall show the written and oral information that the patient has received and what the patient on this background has indicated.

§ 37. In addition to any cosmetic treatment, a picture of the patient with a focus must always be taken in the area to be dealt with. The image must be included in the patient file and stored according to the applicable rules for the storage of patient records.

Paragraph 2. If the patient meets for subsequent checks, a picture of the patient with the same focus and size as referred to in paragraph 1 shall be taken at an appropriate time following the cosmetic treatment. 1 mentioned image. The image must be included in the patient file and stored according to the applicable rules for the storage of patient records.

Chapter 7

Penalty provisions

§ 38. The penalty shall be penalised by the penalty which is in breach of section 3, section 4, section 6, section 7, section 9 (4). 2, section 10 (4). paragraphs 2 and 3, section 11, sections 14 and section 26 (3). 3 and 4.

Chapter 8

Entry into force

§ 39. The announcement shall enter into force on 3. July, 2014.

Paragraph 2. At the same time, notice No 1464 of 28. December 2012 on cosmetic treatment.

NHS, the 27th. June 2014

Else Smith

/ Anne Mette Dons