Key Benefits:
The Prime Minister,
On the report of the Minister of Health and Solidarity,
In view of the Single Convention on Narcotic Drugs adopted by the United Nations on 30 March 1961, Amended by the Protocol adopted by the United Nations on 25 March 1972;
In view of the Convention on Psychotropic Substances adopted by the United Nations on 21 February 1971;
In view of the United Nations Convention against the Illicit Traffic in Narcotic drugs and psychotropic substances adopted on 19 December 1988;
Given the Penal Code;
Given the code of public health, including articles L. 5124-1, L. 5124-18, L. 5132-1 and L. 5132-8;
Given the rural code;
Given the code of the Customs;
Due to the amended Act No. 78-17 of January 6, 1978 relating to computers, files and freedoms;
In the opinion of the National Council of the Order of Pharmacists dated 5 May 2006;
In the opinion of the National Council of the Order of the Physicians as of May 10, 2006;
In the opinion of the Board of Governors of the Veterinary Order of 17 May 2006;
In view of the opinion of the National Commission on Informatics and Freedoms dated 19 July 2006;
The Council of State (social section) heard,
Describes:
Chapter IV of Title II of Book I of Part V of the Public Health Code is thus amended:
I.-To the a of Article R. 5124-34, the words: The Chairman of the Board of Directors or a Director General " Are replaced by the words: " The Chairman of the Board of Directors as Director General, the Director General or a Deputy Director General ".
II. -In R. 5124-36, a final paragraph is added as follows:
" The responsible pharmacist shall participate in the deliberations of the management, administrative, management or supervisory bodies, or of any other body Having an executive office, undertaking or organisation, where such deliberations concern or may affect the exercise of the tasks under its responsibility and listed in 1 ° to 7 ° of this Article. "
In Chapter V of Title II of Book I of Part V of the Public Health Code, Article R. 5125-45 is replaced by the following provisions:
" Art. R. 5125-45. -Any dispensation or dispensation by a pharmacist of a compounding or compendial preparation shall immediately be the subject of a transcription on a book or record by any appropriate system.
Each transcript or Record has a different and chronological order number, as well as the following:
-the date of completion or issuance of the preparation;
-the name and address of the prescriber for compounding;
-the name and address of the patient, at the time of the transcription or the registration of the grant, and, in the case of a veterinary compounding, the name, first name, address of the holder of the animals, the identification of the animals as to their Species, age, sex, identification number or any means of identifying the lot of animals;
-the complete qualitative and quantitative composition of the preparation with an indication of the lot number of each raw material and the name The supplier;
-the quantity produced or issued with an indication of the mass, volume and number of units of catch for the unit forms;
-the identification of the person who completed the preparation.
Upon registration or Of the registration of the grant of a compendial preparation, its composition shall be replaced by the serial number.
Registration systems shall, at the request of any supervisory authority, permit an immediate edition of the Data provided in R. 5132-10. Each page is published with the name and address of the office. The data in these systems must not be modified after validation of their registration. They must be shown on a medium guaranteeing their durability and integrity. Their duplication is compulsory and must be ensured in two separate media, the first being used for the usual consultation, the latter being held in reserve. Archived data must be accessible, accessed and used for the duration of their storage. "
In Chapter VI of Title II of Book I of Part V of the Public Health Code, Article R. 5126-113 is amended as follows:
After the words: Of the order of physicians " Are added the words: " And the competent counsel of the order of pharmacists ".
Chapter II of Title III of Book I of Part V of the Public Health Code is amended as follows:
I.-In the first paragraph of Article R. 5132-6, the words: The drugs mentioned in the Section " Are replaced by the words: " Drugs in lists I and II and drugs classified as narcotic ".
II. -Article R. 5132-9 is replaced by the following:
" Art. R. 5132-9. -Persons entitled to execute orders or orders containing medicinal products other than preparations falling within the scope of this section shall promptly transcribe them in ink, without white or overloaded, on a register or Record immediately by any appropriate system that does not allow any modification of the data it contains after validation of their registration.
Recording systems allow an immediate release at the request of any authority Of the particulars provided for in Article R. 5132-10, each page published to contain the name and address of the Office. The data they contain must be shown on a medium guaranteeing their durability and integrity. In addition, they must be duplicated in two separate media, the first being used for regular consultation, the latter being held in reserve. Archived data must be accessible, accessed and used for the duration of their storage. "
III. -In Article R. 5132-10, the last paragraph is replaced by the following:
" Records or computerized records shall be kept for a period of ten years and shall be kept at the disposal of the supervisory authorities during The prescribed duration. These records must be able to be edited on paper and be classified by patient, drug and chronological order. They shall be made available to the supervisory authorities at their request. "
IV. -Section R. 5132-15 is amended as follows:
1. The 1 ° and 2 ° are replaced by the following:
" 1 ° If this drug is intended for man, a white space, surrounded by a coloured net, in which the pharmacist or dispensing physician records the prescribed dosage; if it is A drug classified as narcotic or subject to the regulation of narcotic drugs, the pharmacist or physician dispensing the name, address and serial number referred to in section R. 5132-10; and
2 ° if it is intended for the animal, A white space, surrounded by a coloured net, in which the pharmacist or dispensing veterinarian records the prescribed dosage and the statement provided for in the 13 ° of Article R. 5141-73 in black characters on a red background. "
2. In the fifth paragraph, the following sentence is added:
" In the case of a drug classified as narcotic or subject to the regulation of narcotic drugs, the pharmacist or dispensing veterinarian shall also enter his name, address and number Pursuant to R. 5125-45. "
3. The last paragraph is replaced by three paragraphs drafted as follows:
" Where the medicinal products are contained in an outer packaging complying with the provisions of this Article:
1 ° The statement " Only on prescription is not Mandatory for primary packaging containing only one dose of use;
2 ° " Comply with prescribed doses is not mandatory for light bulbs or other primary packaging for which the apposition of This statement would not allow for optimum legibility of the references provided for in Articles R. 5121-142 and R. 5141-74. "
V. Article R. 5132-19 is supplemented by a paragraph written as follows:
" The officials and persons referred to in the first subparagraph shall also be required to justify at any time the authorisation issued under the Article R. 5132-75. "
VI. -Article R. 5132-26 is amended as follows:
1. After the second subparagraph, a paragraph shall be inserted
follows: However, in the establishments referred to in Articles R. 5124-2 and R. 5142-1, drugs and substances, preparations and products covered by List I and List II is held at a location or location where access is restricted to authorized personnel. "
2. In the third paragraph, the word " Two " Is replaced by the word: " Three ".
VII. Article R. 5132-28 is repealed.
VIII. -Article R. 5132-30 is amended as follows:
1. In the second paragraph, the words: 14 days or seven days " Are deleted.
2. In the third paragraph, after the words: Processing time ", added the word:" Maximum ".
3. The last paragraph is replaced by the following:
" The prescriber shall refer to the order the processing time corresponding to each fraction. However, for specific reasons relating to the situation of the patient, it may exclude the reference to "grant in one time only". "
IX. -In R. 5132-33, the words: Twenty-four Hours " Are replaced by the words: " Three days ".
X. -R. 5132-34 is repealed.
XI. -Section R. 5132-35 is amended as follows:
1. The first paragraph shall be replaced by the following:
" A copy of any order containing the prescription of one or more medicinal products classified as narcotic or subject to the regulation of narcotic drugs, Section R. 5132-13 is retained for three years by the pharmacist or veterinarian. For pharmaceutical specialities, the quantities issued are formulated in units of catch. These copies shall be presented at the request of the supervisory authorities. "
2. The fourth paragraph is repealed.
XII. -Article R. 5132-36 is replaced by the following:
" Art. R. 5132-36. -Any entry and exit of substances and medicinal products classified as narcotic shall be entered by the persons referred to in Article R. 5132-76 on a register or registered by a specific computer system complying with the conditions
a) No modification of the data shall be possible after validation of their registration;
(b) An immediate edition of the particulars provided for in this Article shall be capable of being made at the request of any Control;
(c) Each page edited must contain the name and address of the institution.
Registration or recording of entries and exits shall be made at each operation, specifying the date on which it is established.
Registration Or the recording of entries includes the designation and quantity of narcotics received and, for proprietary medicinal products, their designation and the quantities received in units of catch.
The registration of outputs includes:
1 ° For Compounding and compendial preparations, including those referred to in article R. 5125-45, the designation and quantity of narcotic drugs used;
2 ° For pharmaceutical specialities, their designation and the quantities issued in Socket units
A monthly balance of input and output is entered in the register or edited. These entries are made in ink, without white, or overloaded.
Each year, the inventory is inventorized, by weighing and discounting. The differences between the scale and the inventory shall be subject to the control of the public health inspector or, where appropriate, the veterinary inspector, on the first visit following the establishment of the inventory. Where appropriate, references to the discrepancies identified shall be entered on it. This inventory is carried out on the register in ink, without white or rature or overloaded, or by electronic record. No changes to the data should be possible after validation of their registration. The data must be shown on a medium guaranteeing their durability and integrity. Their duplication is compulsory in two separate media, the first being used for regular consultation, the latter being held in reserve. Archived data must be accessible, accessed and exploited for the duration of their storage.
In the case of expiry, alteration or return, the pharmacopoeial practitioner, or the veterinarian referred to in article L. 5143-2, shall denaturation of substances, preparations or medicinal products classified as narcotic in the presence of a colleague, appointed under conditions precluding reciprocity and any conflict of interest by the President of the Regional Council of The order of the pharmacists, or, for the overseas pharmacists, the Central Council E, or, for the veterinarians, the President of the Regional Council of the Veterinary Order. A month before the proposed operation, he shall inform the pharmacist regional public health inspector in writing, or, where appropriate, the departmental director of veterinary services, indicating the expected date, names, quantities and all Details of the shapes and conditions of the products to be destroyed. After destruction of the denatured products, it shall send to the pharmacist regional public health inspector or, where appropriate, to the departmental director of veterinary services, a copy of the document attesting to that destruction. The procedures for the destruction of denatured products must comply with the regulations in force for the disposal of waste. A document attesting to the destruction shall be kept by the holder at the disposal of the supervisory authorities. The model of the document attesting to the destruction is fixed by the decree of the ministers responsible for health and agriculture after the opinion of the Director-General of the French Health Products Safety Agency. These provisions shall also apply to the residue resulting from the delinting of specialities.
The Register, the computer records and the editions of such recordings for a period of up to one month and the documents attesting to the Destruction shall be kept for ten years from the date of their last mention, in order to be presented at the request of the supervisory authorities. "
XIII. -Article R. 5132-37 is replaced by the following:
" Art. R. 5132-37. -The pharmacist who assigns his Office or the veterinarian who assigns his place of professional practice shall, in the presence of the purchaser, carry out an inventory of the substances, preparations or medicinal products classified as narcotic. This inventory shall be carried over to the special register of narcotic drugs or in computer records and, in this second case, annexed to the editions of the registrations and countersigned by the persons concerned.
The transferor shall deliver to the purchaser who Gives discharge of the register of narcotic drugs or registrations and, in this second case, the editions of the recordings and the documents to be kept under articles R. 5132-32, R. 5132-35 and R. 5132-36.
In the case of final closure of The office or domicile of the veterinary professional, this register or the recordings and, in this second case, the editions of the recordings and such documents shall be deposited at the regional inspection of the pharmacy or, where appropriate, at the Departmental management of veterinary services.
At the time of the definitive closure of the pharmacopoeial or home, the pharmacist holding the pharmacopoeia or the veterinarian destroys the substances or preparations, as well as the medicinal products classified As narcotic under the conditions set out in R. 5132-36. "
XIV. -Article R. 5132-38 is amended as follows:
The 2 ° is replaced by the following:
" 2 ° The gross mass and tare corresponding to the packaging used; ".
XV. -Article R. 5132-39 is amended as follows:
1. In the first paragraph, the last sentence is replaced by the following:
" The same applies to medicinal products or products which, in the case of misuse as defined in Article R. 5121-153 or in the case of pharmacodependence as defined In Article R. 5132-97 or in the case of abuse as defined in Articles R. 5121-153 and R. 5132-97 may require control at certain stages of their marketing as well as of their prescription. "
2. In the second paragraph, after the words: Medicines ", the words:" Containing these substances or preparations " Are replaced by the words: " Mentioned in the first paragraph of this Article. "
3. A final paragraph is added as follows:
" When these medicinal products or products are used in veterinary medicine, the Director of the French Health Products Safety Agency seeks, in advance of his proposal, The opinion of the Director General of the French Food Safety Agency. "
XVI. -Section 2 of Chapter II of Title III of Book I of Part V is thus amended:
1. Subsections 2, 3 and 4 of this section become subsections 3, 4 and 5 respectively.
2. After subsection 1, a sub-section 2 is created as follows:
"Subsection 2
" Substances and preparations other than those referred to in
1 and Sub-sections 3, 4 and 5
" Art. R. 5132-44-1. -In the case of lists I or II, substances and preparations other than those mentioned in section 1 shall be subject to the provisions of Articles R. 5132-1 to R. 5132-26. "
XVII. -Article R. 5132-45 is replaced by the following:
" Art. R. 5132-45. -For reasons of hygiene and public health, the production, manufacture, transport, import, export, possession, supply, transfer, acquisition or employment as well as advertising of the substances or preparations mentioned in Article L. 5132-2 may be subject to prohibitions or restrictions or specific requirements defined after the opinion of the Higher Council of Public Hygiene of France, by order of the Minister responsible for health and, as the case may be, Ministers responsible for agriculture, consumption, customs, the environment or industry. "
XVIII. -Article R. 5132-48 is replaced by the following:
" Art. R. 5132-48. -The production, manufacture, transport, import, export, possession, supply, transfer, acquisition or use of the substances or preparations referred to in Article L. 5132-2 shall be prohibited. A name likely to cause confusion with a food, a drug, or a cosmetic product. "
XIX. -Section R. 5132-74 is amended as follows:
1. In the first paragraph:
a) The words: Production, placing on the market, employment ' Are replaced by the words: " The production, manufacture, transport, import, export, possession, supply, transfer, acquisition or Employment " ;
b) After the words: " Substances or preparations " Are inserted the words: " And plants or parts of plants ".
2. In the second paragraph, the words: Substances or preparations " Are replaced by the words: " Substances or preparations and plants or parts thereof ".
XX. -Article R. 5132-76 is replaced by the following:
" Art. R. 5132-76. -By way of derogation from the provisions of the first paragraph of Article R. 5132-74, take place of authorisation, for the sole purpose of professional use:
1 ° Registration in the order of pharmacists of pharmacists with pharmacopoeia and pharmacists Managers of mutual pharmacy pharmacies or membership in the active framework of the health service of the armed forces;
2 Registration to the pharmacists of pharmacists who are responsible for the management of the pharmacy for indoor use authorized under the Article L. 5126-7 or membership in the active framework of the health service of the armed forces;
3 ° Enrollment in the order of veterinarians or, if they belong to the active framework of the armies, the quality of veterinarians of the armies;
4 ° The power granted by the fourth paragraph of Article L. 5143-2 to the heads of pharmacy and toxicology services of the national veterinary schools;
5 ° The authorisation of the prefect issued pursuant to Article L. 4211-3;
6 ° La Agreement between a pharmacist and a specialised drug-dependent care centre referred to in the second paragraph of Article D. 3411-10 or the prefectural authorisation granted to the specialised drug-dependent care centre doctor provided for in the Third paragraph of Article D. 3411-10;
7 ° For establishments referred to in Article L. 5126-6 other than specialised centres for the care of addicts, the inclusion in the Council of the order of doctors for doctors attached to these Institutions as well as the agreement between the pharmacist and these institutions. "
XXI. -Article R. 5132-77 is amended as follows:
1. The first paragraph shall be replaced by the following:
" The authorization referred to in R. 5132-74 may be granted only to a natural person. In the undertakings referred to in Articles L. 5124-2 and L. 5142-1, authorisation may be requested for the responsible pharmacist, the delegated pharmacists and the assistant pharmacists, as well as for the responsible veterinarian, veterinarians Delegates and assistant veterinarians. In the case of absence of the holders of the authorisation for a period not exceeding 15 days, the authorisation shall be granted under the same conditions to those who replace them, duly registered in that quality in the table of the national order of pharmacists or To the order of veterinarians. The authorisation shall indicate the substances or preparations and the plants or parts of plants whose production, manufacture, transport, import, export, possession, supply, transfer, acquisition or employment is authorised. "
2. In the second paragraph, the words: "Amazing Substances" Are replaced by the words: " Substances or preparations, plants or parts of plants classified as narcotic ".
3. In the third paragraph, a sentence is added as follows: However, there is no fixed amount for government drug collection programs for public health research purposes. "
XXII. -Section R. 5132-79 is amended as follows:
1. At 1 °, after the words: A substance " Are added the words: " A plant or part of a plant ".
2. At 3 °, the words: " Gross and Net Weight " Are replaced by the words: " The gross mass and tare corresponding to the packaging used ".
XXIII. -Article R. 5132-80 is amended as follows:
1. In the first paragraph of Article R. 5132-80, the words: Substances and preparations " Are replaced by the words: " Substances or preparations, and plants, or parts thereof ".
2. The second subparagraph is supplemented by a sentence worded as follows: The quantities stolen or diverted shall be entered in the register provided for in Article R. 5132-36. "
XXIV. -Article R. 5132-81 is replaced by the following:
" Art. R. 5132-81. -Persons mentioned in the 1 ° to 5 ° of Article R. 5132-76 shall not acquire narcotic substances and preparations classified as narcotic than in an establishment holding the authorisation provided for in the first subparagraph of Article R. 5132-75.
I.-The acquisition or transfer of narcotic drugs, excluding those intended for research and teaching purposes and those carried out by persons dispensed under section R. 5132-76, of the authorization provided for Article R. 5132-74, is subject to the use of the order book referred to in II of this Article.
This acquisition or transfer of narcotic drugs is recorded on a special register or registered by a specific computer system Subject to the following conditions:
(a) No modification of the data shall be possible after validation of their registration;
(b) An immediate edition of the information provided for in this Article shall be available at the request of Any supervisory authority;
(c) Each page edited must contain the name and address of the institution.
The date and number of the authorization issued under section R. 5132-74 are listed on the first page of the register. The registration of each operation on the register or registration shall be given an order number which may apply to all products which have been the subject of a single delivery. The registration of each operation is done in ink, without white or overloaded daily. The registration or registration effected by the assignee shall specify the name, profession and address of the assignor and the registration or registration made by the assignor shall indicate the name, profession and address of the assignee. This entry shall also indicate the quantity of the product acquired or assigned, its name or composition and the reference number provided for in Article R. 5132-79.
Where the exploitation is continued under the cover of a new authorisation, the Date and the number thereof shall be mentioned in the register provided for in the preceding paragraph or shall be recorded in order to appear on any edition of that record.
In the case of successive assignments of a product in a package bearing a stamp Origin, the reference number on the original label is retained.
II. -The acquisition of narcotic substances and preparations classified as narcotic by the persons to whom the authorisation provided for in Article R. 5132-74 has been granted, excluding those intended for research or teaching purposes, May take place only on the delivery of two numbered components extracted from a specimen order book of a model determined by order of the Minister responsible for health, taken after the opinion of the Director General of the French Health Safety Agency Health products. The printing and distribution of these booklets is the responsibility of the National Pharmacists' Association, which annually sends to the French Health Products Safety Agency a nominal statement of the books issued in the
Region One of the components is the name and address of the recipient, the signature and the date of the order. He mentions in all letters the name of the products ordered and their quantity. It is retained by the transferor.
The second part refers only to the name and address of the purchaser and the nature of the substances and preparations. It shall be returned, without delay, to the acquirer by the transferor, who shall complete it:
1 ° By indicating, where applicable, the reference number provided for in Article R. 5132-38 or Article R. 5132-79 and the serial number provided for in the I of this Article;
2 ° En Indicating the quantities delivered and the date of delivery;
3 ° by affixing its stamp and signature.
The coins are retained for three years by the parties concerned to be presented to all requisitions of the competent authorities. "
XXV. -Article R. 5132-82 is amended as follows:
1. The first paragraph shall be replaced by the following:
" Persons who manufacture, process or divide narcotics shall be required to enter, at the time of the transaction and thereafter, on the register provided for in R. 5132-81 or To register with the computer system provided for in the same article: "
2. In the sixth paragraph, after the word: Register ", are added the words:" Or on the release of records ".
3. The seventh paragraph shall be replaced by the following:
" This register, records and editions of such registrations by periods of maximum of one month and documents attesting to the destruction referred to in the last paragraph Shall be kept for ten years from the date of the last operation mentioned in order to be presented at any request by the competent authorities. "
4. In the eighth paragraph, the words: " Recorded on the register and countersigned by the persons concerned " Are replaced by the words: " Signed by the transferor and by the purchaser and is retained by the purchaser for ten years ".
5. A ninth paragraph was added as follows: "
" Substances or preparations, plants or parts of plants and medicinal products classified as narcotic are destroyed under the responsibility of the owner of the authorization mentioned in the article R. 5132-74, in the presence of the latter and a bailiff. The holder of the authorisation shall send a copy of the document attesting that destruction to the Director General of the French Health Products Safety Agency in the annual statement provided for in Article R. 5132-83. "
XXVI. Article R. 5132-83 is thus amended:
1. At 2 ° are added the words: " And losses resulting from these operations ".
2. In the seventh paragraph, the words: " R. 5132-75 " Are replaced by the words: " R. 5132-74 ".
3. An eighth paragraph is added as follows:
" In addition, the establishments referred to in Article R. 5124-2 of Article R. 5124-2 shall, at the request of the Director General of the French Health Product Safety Agency, submit the Quantities transferred monthly. "
XXVII. -In Article R. 5132-84, the first paragraph shall be replaced by the following:
" The production, manufacture, transport, import, export, possession, supply, transfer, acquisition or use of substances or Preparations, plants or parts of plants listed in the tables of the Single Convention of 30 March 1961 on narcotic drugs or the Convention of 21 February 1971 on psychotropic substances, as well as products containing such substances Or preparations, plants or parts of plants may be prohibited, on the proposal of the Director General of the French Health Products Safety Agency, by order of the Minister responsible for health and, in the event of the prohibition On the import or export of the Minister responsible for customs. "
XXVIII. -In Article R. 5132-85, the first paragraph shall be replaced by the following:
" The production, manufacture, transport, import, export, possession, supply, transfer, acquisition or use of khat are prohibited. And preparations containing or prepared from the khat. "
XXIX. -Article R. 5132-86 is amended as follows:
1. The first paragraph shall be replaced by the following:
" Production, manufacture, transport, import, export, possession, supply, transfer, acquisition or employment are prohibited: "
2. At 1 °, the word: " Preparations " Is replaced by the word: " Products ", and words:" Those obtained " Are replaced by the words: " Those obtained ".
3. The 2 ° is replaced by the following:
" Tetrahydrocannabinols, with the exception of the delta 9-tetrahydrocannabinol, their esters, ethers, salts and salts of the aforesaid derivatives and of the products containing them. "
4. In the last paragraph, after the words: Devoid of stunning properties ", are added the words:" Or products containing such varieties. "
XXX. -In Article R. 5132-87, the words: Substances and preparations " Are replaced by the words: " To substances or preparations, plants, or parts of plants ".
XXXI. -Section R. 5132-88 is amended as follows:
1. In the first paragraph, the words: Production, placing on the market, employment ' Are replaced by the words: " Production, manufacture, transport, import, export, possession, supply, transfer, acquisition or employment ".
2. The last paragraph is supplemented by the following sentence:
" The authorisation shall also be subject to the transcription of the operations on a register assigned to that use and to the sending once a year, before 15 February following the previous calendar year, To the administrative authority which has granted authorisation for a statement of quantities received and transferred. "
XXXII. -In Article R. 5132-89, the 2 °, 3 ° and 4 ° are replaced by the following:
" 2 ° Registration for Pharmacists of Pharmacists with Pharmacists and Pharmacists in Pharmacies or Membership in Pharmacists The active framework of the health service of the armed forces;
3 ° The registration in the order of pharmacists of pharmacists providing for the management of the pharmacy for internal use authorised under Article L. 5126-7 or belonging to the active framework of the Health service of armies;
4 ° Enrollment in the order of veterinarians for veterinarians or, if they belong to the active framework of the veterinary service of the army, the quality of veterinarians of the armies. "
XXXIII. -Article R. 5132-90 is replaced by the following:
" Art. R. 5132-90. -By way of derogation from the third paragraph of Article R. 5132-88, for public research or teaching bodies, the authorisation provided for in this Article shall be given by order of the regional prefect, after obtaining the opinion of the pharmacist regional health inspector Under the same conditions as those laid down in Article R. 5132-77 for narcotic drugs. "
XXXIV. -Article R. 5132-95 is replaced by the following:
" Art. R. 5132-95. -The provisions of Article R. 5132-79, except those provided for in 5 ° and 6 ° of that Article, shall apply to containers or packaging containing psychotropic substances or their preparations.
The label shall also bear:
1 ° For list I substances or preparations, a black crossed tibias skull in black on a square background of yellow orange and sufficient dimensions; this square is placed at the upper left corner of the label;
2 ° For substances or preparations in List II, a cross of Saint-André printed in black on a square background of yellow orange and sufficient dimensions; this square is placed at the upper left corner of the label.
The Substances classified as psychotropic substances are held in locked cupboards or premises.
Any theft or diversion of substance or preparation classified as psychotropic is reported without delay to the police authorities, to the inspection Regional pharmacy and the French Health Products Safety Agency. "
XXXV. -In Article R. 5132-97, the 3 ° is replaced by the following:
" 3 ° Serious drug dependence or serious substance abuse, drug dependence or substance abuse, either lethal or likely to cause psychoactive substance abuse Life in danger or result in disability or incapacity, cause or prolong hospitalization or manifest as a congenital abnormality or malformation. "
XXXVI. -Article R. 5132-104 is amended as follows:
1. The 1 ° is modified as follows:
a) The word: " Fifteen " Is replaced by the word: " 16 " ;
b) The provisions of g, h, i, j, k, 1, m, n and o become respectively those of h, i, j, k, l, m, n, o and p;
c) After f, it is Inserted a g so written:
" (g) The Director of Criminal Affairs and Pardons or his representative ".
2. The 2 ° is amended as follows:
(a) In the first and last paragraph, the words: " Eighteen " Are replaced by the words: " Nineteen " ;
(b) In c are added the words: " And a representative of the producers of stunning raw materials Or psychotropic substances; "
3. The 3 ° is repealed.
XXXVII. -In the first paragraph of Article R. 5132-105, the words: At 2 ° and 3 ° " Are replaced by the words: at 2 ° ".
XXXVIII. Article R. 5132-109 is amended as follows:
1. The 5 ° and 6 ° become 6 ° and 7 ° respectively.
2. After 4 ° is inserted a 5 ° worded as follows:
" 5 ° The director of the French Monitoring Centre for Drugs and Drug Addiction or his representative. "
XXXIX. -Article R. 5132-113 is amended as follows:
1. In the second paragraph, after the word: Physician "are added the words: or a pharmacist".
2. After the third subparagraph are added two sub-paragraphs as follows:
" An order of the Minister responsible for health taken on the proposal of the Director General of the French Health Products Safety Agency and after the opinion of the Commission The National Computer and Freedom of Information System defines the operating procedures of the computer system, common to all evaluation centres and information centres on pharmacodependence, intended to collect, record, evaluate and exploit the Data on cases of drug dependence and abuse with a view to providing public decision support in this field.
This system includes, in particular, a national bank of cases, made anonymous, of drug dependence and abuse, intended for Provide support for drug dependency surveys. "
XL. -Article R. 5132-115 is replaced by the following:
" Art. R. 5132-115. -Any undertaking or body operating a medicinal product or product referred to in Article R. 5132-98 shall immediately declare any case of serious or serious abuse of that medicinal product or product thereof to the Director General of The French Health Products Safety Agency. "
Minister of Economy, Finance and Industry, Seal Guard, Minister of Justice, Minister of Health and Solidarity, Minister of Agriculture and Fisheries, and Associate Minister The budget and the reform of the State, a spokesman for the Government, shall each have responsibility for the execution of this Decree, which shall be published in the Official Journal of the French Republic.
Done at Paris, February 5, 2007.
Dominique de Villepin
By the Prime Minister:
The Minister of Health and Solidarities,
Xavier Bertrand
The Minister of the Economy,
Finance and Industry,
Thierry Breton
Justice Minister,
Pascal Clément
The Minister of Justice Agriculture and Fisheries,
Dominique Bussereau
The Minister Delegate to the
Budget and to State Reform,
Government Spokesperson,
Jean-François Copé
