Miscellaneous Provisions Act Health

Original Language Title: Loi portant des dispositions diverses en matière de santé

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Published the: 2016-07-01 Numac: 2016024135 SERVICE PUBLIC FEDERAL public health, food chain security and environment 22 June 2016. -Law on miscellaneous provisions health PHILIPPE, King of the Belgians, all, present and future, A salvation.
The House of representatives has adopted and we sanction the following: available introductory Article 1.
This Act regulates a matter referred to in article 74 of the Constitution.
Title 1.
-INAMI Chapter 1. -Changes to the law on compulsory health care and benefits, insurance co-ordinated on 14 July 1994, Section 1. -Notification of the decisions of the College of doctors-directors art. 2 A article 25nonies of the law on compulsory insurance, health care and benefits, co-ordinated on 14 July 1994, inserted by the law of April 27, 2005, renumbered and amended by the law of 7 February 2014, the following changes are made: (1) paragraph 4 is replaced by the following: "the decision of the College of doctors-Directors is notified by the Institute at the same time to the recipient and to the insurer within a period of 15 working days to" date of approval by the College of doctors-directors of the minutes of the meeting where the decision has been adopted. ';
(2) section 5 is repealed.
Section 2. -Administrative simplification of the procedures for drug benefits art.
3. in article 18, paragraph 4, of the same law, replaced by the law of January 25, 1999 and amended by laws of the December 24, 1999, 10 August 2001 and 27 December, 2012, the last two sentences are replaced by the following: "it shall particularly respect of expenditure and standard partial annual budget target for drugs and other pharmaceutical benefits.
To this end, the health care Service established every three months three summary notes, the first containing the changes to the list referred to in article 35, § 2B, the second changes to the list referred to in article 35bis and third changes to the list referred to in article 35 § 2quater. "."
Art. 4. at article 35 of the same Act, amended last by the law of December 19, 2014, the following changes are made: (1) in paragraph 1, paragraph 1 is replaced by the following: "The King establishes the nomenclature of health benefits, with the exception of the services referred to in article 34, paragraph 1, 4 ° bis, 5 °, 19 °, 20 ° and 20 ° bis.";
(2) in paragraph 1, paragraph 2, fourth sentence, the words "(et 5°, a), 19 ° and 20 °," are repealed;
(3) in paragraph 1, paragraph 2, fifth sentence, the words "19 ° and 20 °", are repealed;
(4) in paragraph 1, paragraph 2, "(Ces critères d'admission en ce qui concerne les prestations visées à l'article 34, alinéa 1er, 5°, a) sentences, concern prices, estimates of volume, the cost of the treatment of pharmaceutical supplies, its patented or not of the main active principle, the elements of medical, epidemiological, therapeutic and social order."
The admission of the benefits referred to in article 34, paragraph 1, 5 °, has), the subject of a review at least every five years. For benefits referred to in article 34, paragraph 1, 5 °, (a), for which there is already a refund, the pharmaceutical Technical Council is empowered to review the criteria for admission as well as their application. "This revision can be done for a therapeutic class or a group of compounding, following the Anatomical Therapeutical Chemical Classification, prepared under the responsibility of the World Health Organization Collaborating Center for Drug Statistics Methodology, or a preparation masterful separate." are repealed;
(5) in paragraph 1, paragraph 9, the words "(5°, a) and (d), and 15 °, 19 °, 20 ° and 20 ° bis,"are each time replaced by the words "(5°, d), and 15 °";
(6) in paragraph 1, clause 10 is repealed;
(7) in paragraph 2, the 6 ° is repealed;
(8) there is inserted a 2quater paragraph as follows: "§ 2quater." The King confirms the list of reimbursable pharmaceutical benefits referred to in article 34, paragraph 1, 5 °, a), 19 °, 20 ° and 20 ° bis.
On proposal Technique pharmaceutical Council, or after notice of it, the Minister modifies the list of reimbursable pharmaceutical benefits referred to in article 34, paragraph 1, 5 °, has), 19 °, 20 ° and 20 ° bis, as well as the repayment terms are related.
On the proposal of the Council technical pharmaceutical, the King determines the procedure to be followed by those seeking admission, a change or deletion of a pharmaceutical benefit on the list referred to in paragraph 1.
It also sets deadlines and obligations in case of admission application, modification or deletion.
The list of pharmaceutical benefits referred to in article 34, paragraph 1, 5 °, a), 19 °, 20 ° and 20 ° bis, is determined on the basis of admission criteria defined by the King and that these benefits can be divided into different categories.
Regarding pharmaceutical benefits referred to in article 34, paragraph 1, 5 °, (a), these admission criteria concern prices, estimates of volume, the cost of treatment of drug benefits, the patented trait or not the main active principle, the elements of medical, epidemiological, social and therapeutic.
Regarding pharmaceutical benefits referred to in article 34, paragraph 1, 19 °, 20 ° and 20 ° bis, these admission criteria concern prices, the cost of insurance and the medical, therapeutic and social elements.
The admission of drug benefits referred to in article 34, paragraph 1, 5 °, has), the subject of a review at least every five years.
The King determines, in regards to drug benefits referred to in article 34, paragraph 1, 5 °, has), the procedure laying down the basis for reimbursement, whereby the Council technical pharmaceutical formulates a proposal, in light of the need to develop and which relate among other packaging available in retail, the retail price to the pharmacist and the data on the quantities sold. It sets the conditions and fees that compulsory insurance is involved in the cost of these benefits, as well as the maximum amounts as appropriate.
The reimbursement of pharmaceutical benefits referred to in article 34, paragraph 1, 5 °, a), 19 °, 20 ° and 20 ° bis, may be subject to the approval of the medical officer.
The King may also determine the conditions under which the medical officer can check if issued drug benefits referred to in article 34, paragraph 1, 5 °, a), 19 °, 20 ° and 20 ° bis, which gave rise to the refund were prescribed by the provider in accordance with fixed repayment terms.
The King fixed the appeals procedure introduced by the healthcare provider from the decisions of the medical consultant.
The King may determine the cases in which Service of the healthcare of the Institute may propose to the Minister of changes in the list of pharmaceutical benefits referred to in article 34, paragraph 1, 5 °, a), 19 °, 20 ° and 20 ° bis, without intervention of the pharmaceutical Technical Council if technical corrections to different types of errors.
The King may determine the cases in which the Institute health care Service may submit to the Minister of changes to the list of pharmaceutical benefits referred to in article 34, paragraph 1, 5 °, a), 19 °, 20 ° and 20 ° bis, on the advice of the Council technical pharmaceutical, to ensure greater consistency between the terms of repayment of repayable benefits or for administrative simplifications , and so whether it's changes having no effect on the target group and if any already reimbursable directions. "."
Art. 5. in title III, chapter V, of the same Act, it is inserted a section XXIII: "Section XXIII. (DelesDe obligations deles de firmes qui mettent deles de prestations pharmaceutiques visées à l'article 34, alinéa 1er, 5°, a), 19 °, 20 ° and 20 ° bis, on the Belgian market and demand admission to refund ".
Art.
6. in section XXIII, inserted by article 5, it is inserted an article 77octies as follows: art. 7octies. § 1. The firm makes pharmaceutical benefits referred to in article 34, paragraph 1, 5 °, (a), 19 °, 20 ° and 20 ° bis, on the Belgian market and who has requested the refund is required, from the introduction of a refund request, to ensure that the pharmaceutical benefit concerned is actually available at the latest at the date of entry into force of the refund and to ensure continuity in the availability of pharmaceutical delivery.
When the firm makes pharmaceutical benefits referred to in article 34, paragraph 1, 5 °, (a), 19 °, 20 ° and 20 ° bis on the Belgian market and who has requested the refund is unable to supply the market for packaging, packaging is considered to be unavailable. The firm shall notify the start date, the end date and the reason for the unavailability Institute health care Service.
§ 2. If the Service

Institute health care is informed of the unavailability of a pharmaceutical benefit referred to in article 34, paragraph 1, 5 °, a), 19 °, 20 ° and 20 ° bis, other than by the company or as the case may be by the FAMHP, the Service request confirmation to the firm that the pharmaceutical provision is actually unavailable. The firm has 14 days from the receipt of this request to confirm or deny the unavailability by mail recommended with acknowledgement of delivery. If she crippled her, she joined his sending evidence attesting to the pharmaceutical service is available. If the firm confirms the unavailability, it specifies the start date, the end date and the reason for unavailability.
If the firm does not respond within the time limit, or if the items the firm provides do not allow to establish with certainty the availability of pharmaceutical delivery, pharmaceutical delivery is removed as soon as possible the list of right and without taking into account the procedures determined under article 35 § 2quater.
§ 3. If the firm communicates the packaging will be unavailable for more than 12 months, or if the absence lasts more than twelve months, concerned packaging is removed from right of the list, without taking account of the procedures determined under section 35, § 2quater, respectively the first day of the month following the expiry of a period of 10 days from the receipt of the notification or the first day of the thirteenth month of unavailability.
§
4. If the downtime is the result of a proven case of force majeure, the packaging is of right to new registrant on the list the first day of the month following the end of the unavailability, without taking account of the procedures determined under section 35, §. 2quater "."
Art.
7. article 213, § 2, of the same Act, replaced by the law of 22 February 1998 and amended by the law of March 19, 2013, is supplemented by a paragraph to read: "by way of derogation to paragraph 2, the opinion of the Committee on insurance and the general Council is not necessary for the modification of the lists of reimbursable benefits referred to in articles 35 , § 2B, 35, § 2quater 35bis and 35septies/2. "."
Art. 8. This section comes into force January 1, 2018.
The King may determine a date of entry into force prior to the date mentioned in the first paragraph.
Section 7 comes into force the day after its publication in the Moniteur belge for the lists of reimbursable benefits changes, referred to in articles 35, § 2B, 35bis and 35septies.
Section 3. -Procedure for changes in the nomenclature, art.
9A article 27 of the same Act, amended lastly by the law of December 15, 2013, the following changes are made: (1) in paragraph 2, the words "and article 35 § 2B"are replaced by the words", in article 35, § 2B and article 35 § 2quater";
(2) in paragraph 4, the words "in the case of reasoned exceptional circumstances, this notice" shall be replaced by the words "If the notice was not formulated in session, he";
(3) in paragraph 4, the words "at a meeting or in writing" shall be inserted between the words "formulated" and "in the five day period referred to above.".
Section 4. -Affections Pediatric art. 10A article 35bis, § 8, of the same Act, inserted by the law of August 10, 2001 and amended by the law of December 22, 2003 and December 19, 2008, a written paragraph as follows is inserted between paragraphs 1 and 2: "the King may lay down the conditions for a special procedure whereby the reimbursement of a specialty in the list can be changed , for repayment of this specialty in the under 18 beneficiaries, provided that this specialty is already paid to beneficiaries over the age of 18 in the same indication. "."
Section 5. -Drug art. 11. in article 35bis of the same Act, inserted by the law of August 10, 2001 and amended last by the law of 22 June 2012, the following changes are made: (1) in paragraph 2, paragraph 3, the last sentence is repealed;
(2) paragraph 2 is supplemented by two paragraphs written as follows: "changing the list comes into force the day after the day that the decision to amend the list was published on the website of the Institute.
If changing the list decreases the access rights of patients to drug therapies, the amendment comes into force until the first day of the month following the expiration of the period of 10 days which commences the following day of its publication in the Official Gazette. ";
(3) in paragraph 4, paragraph 8, the words "paragraph 3" are replaced by the words "paragraph 4";
(4) in the Dutch text of paragraph 4, paragraph 9, the words "article 5" shall be replaced by the words "het Vierde lid".
(5) in paragraph 5, paragraph 2, the words "come into force changing the list to the first day of the month following the expiration of a period of ten days which commences the day after the publication in the Belgian Moniteur. The King can define in which cases it may be derogated from this date of entry into force."are replaced by the words"changing the list comes into force the day after the day where changing the list was published on the website of the Institute.".
Art. 12. in article 35bis, § 7, of the same Act, inserted by the law of August 10, 2001 and amended lastly by the law of December 10, 2009, five written paragraphs as follows shall be inserted between paragraphs 1 and 2: "skilled information confidential by the parties during the negotiations or the conclusion of an agreement with the Institute will be mentioned in the annex to the convention and will be kept confidential."
The Institute, its employees and its agents, preserve and ensure confidentiality.
It can only be derogated from the above-mentioned privacy: (1) if it is ordered in a proceeding or investigation disciplinary, administrative, criminal or civil.
(2) in the case where the applicant comes on its own initiative in a collective refund procedure with one or more partner countries.
In the cases referred to in paragraph 4, 1 °, the Institute may share information qualified as confidential by the parties with the competent authorities.
In the cases referred to in paragraph 4, 2 °, the Institute may share the information designated confidential by the parties with the competent foreign authorities concerned, provided that they are bound by this confidentiality. "."
Art. 13. in article 35ter, of the same law, replaced by the Act of 27 December 2005 and amended last by the law of December 19, 2014, the following changes are made: (1) in paragraph 2, paragraph 3, the words "on a monthly basis and" are repealed;
(2) in paragraph 2bis, paragraph 3, the words "on a monthly basis and" are repealed;
(3) in paragraph 3, paragraph 3, the words "on a monthly basis and" are repealed.
Art. 14 articles 17 to 19 of the Act of February 7, 2014 with various provisions of accessibility to health care are repealed.
Art. 15. This section comes into force September 1, 2016.
The King may determine a date of entry into force prior to the date referred to in paragraph 1.
Section 6. -Unavailability of drugs art. 16. in article 72bis, § 1erbis of the law on compulsory health care and benefits, insurance co-ordinated on 14 July 1994, inserted by the law of December 22, 2008 and amended by the Act of April 10, 2014, the following changes are made: (1) paragraph 1 is supplemented by the following sentences: "If the concerned specialty is mainly intended for use in hospitals and the responsible applicant does not have a public market with a hospital in" a period of twelve months following the date of entry into force of the refund, the applicant can get an exception to the deletion of right. The applicant shall forward to the Institute, at the latest within seven days following the first day of the 11th month following the date of entry into force of the refund. If the unavailability is maintained, the concerned specialty will be removed from right from the list the first day of the month following the date of entry into force of the refund 60. ";
(2) paragraph 2 is supplemented by the following sentences: "If the concerned specialty is mainly intended for use in the hospital and if the responsible applicant does not have a public market with a hospital in a period of 12 months following the beginning of the unavailability, the applicant can get an exception to the deletion of right. The applicant shall forward to the Institute, at the latest within seven days following a period of eleven months following the beginning of the unavailability. If the unavailability continues, the concerned specialty will be removed from right of the list the first day of the 60th month following the beginning of the unavailability. ";
(3) in paragraph 3, the last sentence is replaced by the following: "If the concerned specialty is mainly intended for use in hospitals and the responsible applicant does not have a public market with a hospital in"

a period of twelve months following the beginning of the unavailability, the applicant can get an exception to the deletion of right. The applicant shall forward to the Institute, at the latest within seven days following a period of eleven months following the beginning of the unavailability. If the unavailability continues, the concerned specialty will be removed from right of the list the first day of the 60th month following the beginning of the unavailability. On the other hand, if the applicant does not respond within the time limit, or if the elements it provides cannot establish with certainty the availability of pharmaceutical specialty, specialty is removed as soon as possible the list of right and without taking into account the procedures provided for in article 35bis. "."
Art. 17 A section 77quinquies of the Act, inserted by the Act of 27 December 2012 and amended by the Act of April 10, 2014, the following changes are made: (1) there is inserted a paragraph 1/1, to read: "§ 1/1." If the unavailability continues, the packaging concerned is removed from right from the list the first day of the twelfth month following the date of entry into force of the refund. If the responsible applicant does not have a public market with a hospital in a twelve month period which follows the date of entry into force of the refund, the applicant can get an exception to the deletion of right. The applicant shall forward to the Institute, at the latest within seven days following the first day of the 11th month following the date of entry into force of the refund. If the unavailability continues, the packaging concerned will be removed from right from the list the first day of the month following the date of entry into force of the refund 60. ";
(2) in paragraph 3, the words "three months" are each time be replaced by the words "twelve months" and the words "of the fourth month of unavailability" shall be replaced by the words "of the thirteenth month of downtime";
(3) paragraph 3 is completed by the following sentences: "If the responsible applicant does not have a public market with a hospital in a period of 12 months following the beginning of the unavailability, the applicant can get an exception to the deletion of right. The applicant shall forward to the Institute, at the latest within seven days following a period of eleven months following the beginning of the unavailability. If the unavailability continues, the packaging concerned will be removed from right from the list the first day of the 60th month following the beginning of the unavailability. "."
Section 7. -Market good prescriptions art. 18 A section 73, § 2, paragraph 3, 1 °, of the same Act, inserted by the law of December 19, 2008 and replaced by the law of December 19, 2014, the following changes are made: (1) the words "which is not unavailable in the sense of article 72bis, § 1erbis," shall be inserted between "trained the specialty" words and the words "including the basis of repayment";
(2) the words "lowest or" are repealed.
Art. 19 section 18 comes into force the first day of the second month following the publication of this law in the Official Gazette.
Section 8.
-Adaptation of the ceiling of personal assessments for dental art. 20. in article 37, § 1, paragraph 3, of the Act, amended by the law of December 20, 1995, by the royal decree of 16 April 1997 and by the laws of the August 22, 2002 27 December 2006 and 29 March 2012, the words ", dentistry" are inserted between the words "podiatry" and the words "and dietetics".
Art.
21 section 20 comes into force the day of the publication of this law in the Official Gazette.
Section 9. -Role of the committees of conventions and agreements in the development of the budget article 22. article 51 of the Act, amended lastly by the law of December 23, 2009, is supplemented by a paragraph as follows: "§ § 8 8" §§ 1 to 7 do not apply to the agreements with the suppliers of implants. "."
Section 10.
-Funding of the centers of forensic art. 23. in article 56, § 3ter of the same Act, inserted by the law of December 26, 2013, the following changes are made: (1) paragraph 1 is supplemented by the words "and charges related.";
(2) paragraph 2 is supplemented by the following sentence: "It also covers non-refundable drugs, as well as all fees related to the care, fees for the registration of data on healthcare and the taxes and taxes of any kind.";
(3) a written paragraph as follows is inserted between paragraphs 2 and 3: "no extra room or fees can be charged to the persons referred to in paragraph 1.".
Section 11. -Art clinical biology laboratories 24. article 63, paragraph 1, 3 °, of the same Act, is repealed.
Art. 25. in article 63, paragraph 2, of the Act, the words "and (3)" are repealed.
Section 12. -Dialysis art. 26. in title III, chapter V, of the same Act, section XIVbis, which contains article 71bis, inserted by the law of August 22, 2002, is repealed.
Art. 27. article 26 come into force October 1, 2016.
The King may determine a date of entry into force prior to the date referred to in paragraph 1.
Section 13. -Allocation key to the financial responsibility of the insurers and advances art.
28. article 196, § 1, paragraph 5, of the Act, amended lastly by the law of July 24, 2008, is complemented by the following sentences: "for the closing of the accounts from the financial year 2012, this key will be adapted to the evolution of the number of members by insurance between the year of calculation of the allocation key and the year of the closing of the accounts. The allocation key is multiplied by two quotients, namely: 1) the quotient of the number of members of the closing year and the number of members of the year;
(2) the quotient of the sum of normative expenditures of the year and the amount of normative expenditures obtained by weighting average normative expenditures of the year by the number of members of the closing year. "."
Art. 29. in article 196, § 2, paragraph 1, of the Act, the words "or in the course of the next year" are inserted after the words "in the course of the biennium".
Art. 30. in article 202, § 1, of the same law, amended by the royal decree of 12 August 1994 and by the laws of the December 20, 1995, December 30, 2001 and December 27, 2006, a written paragraph as follows is inserted between paragraphs 2 and 3: "for the purposes of the preceding paragraph, the second key is adapted to the evolution of the number of members by insurance the year of calculation of the allocation key to fiscal year in" course. The allocation key is multiplied by two quotients, namely: 1) the quotient of the number of members of the current fiscal year and the number of members of the year for the calculation of the allocation key.
(2) the quotient of the sum of normative expenditures of the year for the calculation of the allocation key and the sum of normative expenditures obtained by weighting average normative expenditures of the year for the calculation of the distribution key by the number of members of the current fiscal year."
CHAPTER 2. -Modification of the Act of July 30, 2013 bearing of various provisions unique Section. -Insulins art. 31. in article 30, paragraph 1, of the Act of July 30, 2013 bearing of various provisions, the word "V.8.7," is inserted between the words "V.8.1," and the words "VII.9".
TITLE 2. -FAMHP Chapter 1.
-Amendments to the law of 25 March 1964 on medicines Section 1.
-Temporary shutdown notification period art. 32. in article 6, § 1ersexies of the law of 25 March 1964 on medicines, inserted by the law of 1 May 2006 and amended by law of August 3, 2012 and April 10, 2014, the following changes are made: (1) in paragraph 2, second sentence, the words "in the case of final judgment, this notification takes place" are replaced by the words "This notification takes place";
(2) in paragraph 5, the word "and" is inserted between the words "market" and "information", and the words "and the time frame in which the temporary unavailability should be notified" are repealed;
(3) subsection is supplemented by a paragraph 6, to read: "this paragraph applies also to distributors in bulk referred to in article 12B, § 1, paragraph 3".
Section 2. -Scientific advice or technical art. 33. in article 6sexies of the same Act, inserted by the law of 1 May 2006 and amended by the law of August 3, 2012, the words "management general drugs from the federal public Service health, food chain security and environment" shall be replaced by the word "the FAMHP".
CHAPTER 2. -Changes of the law of 20 July 2006 relating to the creation and the functioning of the Federal Agency of drugs and products of Health Section unique. -Self-monitoring art. 34. in the law of July 20, 2006 on the creation and the functioning of the Federal Agency for medicines and health products, article 4, § 1, paragraph 3, 6 °, amended lastly by the Act of April 10, 2014, is replaced by the following: "(6) legislation: a. to propose to the Minister the regulations for materials"

jurisdiction of the Agency and to ensure monitoring, enforcement, control following regulations related to its tasks as well as their implementation orders:-the law of 24 February 1921 regarding traffic of poisonous, soporific, staggering, psychotropic, disinfectant or antiseptic substances and substances that can be used in the illicit manufacture of astounding and psychotropic substances;
-the law of 25 March 1964 on medicines;
-the law of July 15, 1985 on the use of substances with hormonal, anti-hormonal effect, to beta-adrenergic effect or stimulatory effect of production animals;
-the law of December 19, 2008 on obtaining and use of human body material intended for human medical applications or for purposes of scientific research;
-the law of 28 August 1991 on the practice of veterinary medicine regarding the provision and the prescription of drugs to those responsible for animals;
-the law on the exercise of the professions of health, coordinated care 10 may 2015 in which concerns the issue of drugs;
-the Act of 5 July 1994 to blood and blood derivatives;
-the experiments on the human act of 7 May 2004;
-the law of 24 January 1977 on the health protection of consumers with respect to food and other products;
-the Act of 6 July 2007 reproductive medically assisted and the destination of the supernumerary embryos and gametes, with the exception of articles 4, paragraph 3, 5, 6, 31, 32, 33, paragraph 2, 66, 67, 68, 71 and 72;
-the royal decree No. 80 of 10 November 1967 on the order of pharmacists, training continues;
-the law of 15 December 2013 for medical devices;
(b) to propose to the Minister the regulations for the establishment of a system of self-regulation in the areas within its jurisdiction under this Act. "."
CHAPTER 3. -Changes to the law of December 19, 2008 on obtaining and use of human body material intended for human medical applications or for scientific research purposes unique Section. -Biobanks art.
35 A, article 2 of the law of 19 December 2008 on the use of human body material intended for human or for purposes of scientific research, medical applications and obtaining amended lastly by the law of April 10, 2014, the following changes are made: (1) in the 32 °, the words "to the royal decree No. 78 of 10 November 1967 on the exercise of the professions of health care" are replaced by the words "in the law on the exercise of the professions of health care, coordinated the 10 may 2015 ";
(2) section is completed by the 37 ° to read: "37 ° 'transformation': every manipulation that substantially alters the genetic code of all the cells composing the material human body so that the material is no longer in connection with the donor and can no longer generate significant information about the State of health of the donor.".
Art. (36A article 3, paragraph 3, of the Act, amended by the law of December 23, 2009 and 19 March 2013, the following changes are made: (1) paragraph 1 is supplemented by the e) to read: "(e) the hair and (with the exception of the follicles), nails, urine, breast milk, feces, tears and sweats, except if they are intended for scientific research without human application.";
(2) paragraph 2 is repealed.
Art.
37. in article 7, § 1, paragraph 3, of the Act, the words "referred to in article 11, § 3, paragraph 2, of" shall be replaced by the words "with full approval referred to".
Art.
38. in article 8, § 1, paragraph 1, 2 °, of the law the words "with full approval" are inserted between the words "of ethics" in "as is".
Art. 39. in article 10, § 5, of the Act, a written paragraph as follows is inserted between paragraph 2 and paragraph 3: "where the human body material is taken for research without human application, the information referred to in section 5, paragraph 2 refers also, as appropriate, to the possible transformation that the human body material can undergo , as well as the possible consequences of this transformation referred to in sections 15, § 1, paragraph 3 and 22, § 7, paragraph 1, (2). ".
Art. 40. in article 15, § 1, of the same law, amended by the law of December 19, 2013, the following changes are made: (1) in paragraph 1, the words "or the human body material within the BioBank Manager" are repealed;
(2) paragraph 1 is supplemented by the words "or 20, § 1, or against which no opposition has been expressed in application of article 10 of the law of 13 June 1986 on the levy and the transplantation of organs";
(3) two paragraphs written as follows shall be inserted between paragraph 1 and paragraph 2: "the human body material within the BioBank manager ensures that it puts the human body material at disposal for use: (1) that is consistent with the objectives and activities of the BioBank;" and (2) for which the authorization was given in application of article 10 or 20, § 1, for which no refusal has been communicated in accordance with article 20 § 2, or against which no objection has been expressed in application of article 10 of the law of 13 June 1986 on picking and organ transplantation.
By way of derogation to paragraph 2, (2), the human body material that has undergone a transformation and that traceability was lifted, can be made available for one purpose other than that for which the authorization was given in application of article 10 or 20, § 1, no refusal has been communicated in accordance with article 20 § 2, or against which no objection has been expressed in application of article 10 of the law of 13 June 1986 on the levy and organ transplantation. "."
Art.
41. in article 20, § 1, of the same law, amended by the law of December 23, 2009, the following changes are made: (1) in paragraph 2, the figure "4" is replaced by the number "5";
(2) paragraph 2 is supplemented by a sentence, worded as follows: "article 10, § 7, shall apply with respect to the consent to the treatment of personal data in the context of the secondary use.";
(3) in paragraph 3, the words "referred to in article 11, § 3, paragraph 2, of" shall be replaced by the words "with full approval referred to".
Art.
42. in article 21, paragraph 1, of the Act, amended by the law of March 19, 2013, the words ", which responds to the provisions of article 4 (2), and 11ter, of" shall be replaced by the words "with full approval referred to".
Art. 43. at article 22 of the same law, amended lastly by the law of April 10, 2014, the following changes are made: (1) in paragraph 1, paragraph 2, the words "for the duration of this trial" are replaced by the words "until the publication of the final report of the study";
(2) in paragraph 1, paragraph 6, the words "as referred to in article 11, § 1, of" shall be replaced by the words "with full approval referred to";
(3) in paragraph 2, paragraph 3, the words "the Manager of the human body material in" are replaced by the words "the operator of";
(4) paragraph 7 is replaced as follows: "§ § 7 7" Without prejudice to the provisions of the law of 7 May 2004 on experiments on the human person, human body material within the BioBank Manager can at any time up the traceability of human body material: (1) if the donor or a person authorized to give consent to the collection and use has previously given consent therefor;
(2) if the human body material has undergone a transformation.
In the case referred to in paragraph 1, 2 °, the materiel Manager body human in the BioBank up traceability that after the researcher has declared on the honour the material has undergone a transformation.
Where it is found that there is place to apply article 11, traceability can be lifted once the procedure referred to in article has been entirely respected. "."
Art. 44. in articles 2, 28 ° and 22, § 3, paragraphs 1 and 2, of the Act, amended by the Act of April 10, 2014, the words "article 7 of the royal decree No. 78 of 10 November 1967 on the exercise of the professions of health care" are each time be replaced by the words "article 25 of the law on the exercise of the professions of health care coordinated on 10 may 2015 ".
Art. 45 sections 35 to 44 come into force on a date determined by the King.
CHAPTER 4. -Modification of the law of 7 May 2004 on experiments on the human person single Section. -Biobanks art. 46. in the introductory sentence of article 18/1, of the law of 7 May 2004 on experiments on the human person, inserted by the Act of April 10, 2014, the words "for the duration of this trial" are replaced by the words "until the publication of the final report of the study".
CHAPTER 5.
-Modify - the law of 15 December 2013 for medical devices unique Section.
-Scientific and technical advice

Art. 47. the Act of 15 December 2013 for medical devices is completed by a title 4 to read: "Title 4. -Scientific and technical advice on medical devices art. 58. the King may lay down the conditions and the modalities according to which the Federal Agency for medicines and health products gives a scientific opinion or technique relative to the research and development of a medical device with a view to its possible put on the market or for its eventual modification after its release on the market. It determines the conditions, time and the details of the procedure of processing of these notices, as well as the conditions for obtaining these opinions. "."
CHAPTER 6. -Amendments to the law of 28 August 1991 on the exercise of the veterinary art. 48. article 9, § 2, of the Act of 28 August 1991 on the exercise of the medical veterinarian the following changes are made: (1) the words ", administration" are inserted between the word "prescription" and the words "and the provision";
(2) paragraph is completed with three paragraphs, written as follows: "the King may submit to a check by the vet, to a central data file, the prescription, the provision and administration of drugs with a view to reporting on the medication use and enforcement of measures taken to a reasoned and prudent drug use.
The King sets the terms of registration referred to in paragraph 2, and the use of the central data file. It may fix the terms and conditions according to which the central file can be used to control the delivery and prescription drugs to animals officials.
The King sets including the conditions under which operators identification data may be processed for a univocal and correct record in the data file referred to in paragraph 2 "."
Art. 49. in article 10, § 1, paragraph 2, of the Act, amended by the law of May 19, 2010, the words "and administration" are inserted between the words "supply" and "drugs.
Art. 50. in article 11, paragraph 3, of the Act, the words ", their acquisition and their administration" are inserted between the words "detention" and "officer".
Art. 51. in article 22, 2 °, of the same law, the words ", the Administration" are inserted between the words "prescription" and "and providing".
Art. 52A article 27A of the Act, inserted by the law of 1 May 2006 and amended by the law of 27 December 2006, the following changes are made: (1) in paragraph 1, subparagraph 1, the words "punished within the meaning of articles 20 to 22", shall be inserted between the words "or taken orders in the execution of it," and the words "the official-jurist ", designated for this purpose by the King";
(2) in paragraph 1, paragraph 3 is replaced as follows: "for the offences defined in articles 20 and 21, the amount of the administrative fine may be less than half the minimum or superior to the maximum of the fine imposed for the crime.".
(3) in the 1st paragraph, a paragraph, written as follows, is inserted between paragraphs 3 and 4: "For offences defined in article 22, the amount of the administrative fine cannot be less than 25 euros, nor greater than 5000 Euro.";
(4) in paragraph 1, paragraph 5, becoming paragraph 6, is replaced as follows: "In case of application of article 25, the amount can be doubled.".
Art. 53. in article 34, § 1, paragraph 2, of the same law, amended by the law of 27 December 2004, the word "eight" is replaced by the word "twenty".
TITLE 3. -SPF - Health public, safety of the food chain and environment Chapter 1. -Changes to the law on the exercise of the professions of healthcare, coordinated on 10 may 2015 Section 1. -Assent art. 54. in article 141 of the law on the exercise of the professions of health care, coordinated on 10 may 2015, the word "consistent" is every time revoked.
Section 2. -Federal Council of Allied Arts. (55. in articles 23, § 1, paragraph 4, 71, § 2, 72, § 2, paragraph 1, 76, 119, § 1, 2 °, e), paragraph 2, 133, paragraph 1, 176, paragraph 1, 2 °, and 180 of the Act, the words "National Council of Allied" are each time be replaced by the words "Federal Council of Allied".
Section 3. -Assistant pharmaceutico-technical art.
56. in article 153, paragraph 3, of the Act, amended by the law of 17 July 2015, a written paragraph as follows is inserted between paragraphs 3 and 4: "Notwithstanding paragraph 1 and notwithstanding section 72, § 1, people who do not meet the qualifying conditions provided for in article 72, § 2, paragraph 2, for the profession of assistant pharmaceutico-technique" , but who, on September 1, 2010, performed acts of the profession of assistant pharmaceutico-technique for at least three years, may continue to perform the same acts under the same conditions as the pharmaceutico-technical assistants performing those acts. "."
CHAPTER 2. -Amendments to the law of May 23, 2013, regulating the qualifications required for performing non-surgical aesthetic medicine and cosmetic surgery procedures and regulating the advertising and information about these unique Section acts. -Authorization art.
57. in article 24 of the Act of May 23, 2013, regulating the qualifications required for performing non-surgical aesthetic medicine and cosmetic surgery procedures and regulating the advertising and information related to these acts, amended by the Act of April 10, 2014, the following changes are made: (1) in section 2, paragraph 2 is replaced by the following : "The application for leave must be submitted within a period of two years after the entry into force of article 10."; (2) in paragraph 3, the phrase "the application of empowerment must be submitted within a period of two years after the entry into force of the present article." is replaced by the following: "the application for leave must be submitted within a period of two years after the entry into force of article 10.".
Art. 58. in article 25 of the Act, the words "and no later than September 1, 2015" are repealed.
Art.
59. article 58 comes into force on August 31, 2015.
CHAPTER 3. -Changes to the law of 24 January 1977 on the health protection of consumers with respect to food and other products Section 1. -Definition "tobacco products" art. (60. 1 article, (2), d), the law of 24 January 1977 on the protection of the health of consumers in what concerns food and other products is supplemented by the words ", hereinafter referred to as tobacco products".
Section 2. -Labelling of tobacco art. 61. article 8 of the same Act, amended by the law of 22 March 1989, including the current text will form the 1st paragraph, is supplemented by a paragraph 2 as follows: "§ § 2 2." By way of derogation to paragraph 1, references as set out on the label of tobacco products and which are made binding in the execution of this Act are worded anyway in Dutch, french and German, regardless of the linguistic region where the products are put on the market. "."
Enact this Act, order that it is apposed to the seal of the State and published in the Moniteur belge.
Given in Brussels on 22 June 2016.
PHILIPPE by the King: the Minister of Social Affairs and the health public, Mr. Block sealed with the seal of the State: the Minister of Justice K. Geens _ Note (1) Documents of the House of representatives: 1838 - 54 - 2015/2016 No. 1: Bill No. 2: Annex No. 3: Amendment No. s 4 and 5: reports no. 6: text adopted no. 7 : Amendment No. 8: text adopted