The Illicit Manufacture Of Narcotic Drugs And Psychotropic Substances And Drug Purchasing, Receiving, Storage, Distribution, Delivery, Accounting And Disposal Procedures For Medicinal Products And In The Manufacture Of Veterinary Medicinal Products, Me...

Original Language Title: Narkotisko un psihotropo vielu un zāļu iepirkšanas, saņemšanas, uzglabāšanas, izplatīšanas, izsniegšanas, uzskaites un iznīcināšanas kārtība zāļu un veterināro zāļu ražošanā, zāļu un veterināro zāļu lieltirgotavās un aptiekās

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/177101

Cabinet of Ministers Regulations No. 441 in Riga, June 17, 2008 (pr. No. 42) the illicit manufacture of narcotic drugs and psychotropic substances and drug purchasing, receiving, storage, distribution, delivery, accounting and disposal procedures for medicinal products and in the manufacture of veterinary medicinal products, medicine and veterinary medicine and pharmacy of lieltirgotav Issued in accordance with the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" article 37, paragraph 2 and 3 i. General questions 1. determines the order in which substances and veterinary medicinal products included in Latvia controlled narcotic substances, psychotropic substances and precursors, (II) and (iii) the list receives, distributes, purchases, served, stored, recorded, and obliterate the (movement), medicinal products or substances in the manufacture of veterinary medicinal products, medicinal or veterinary medicine and pharmacy lieltirgotav (except the General, or the open veterinary pharmacies, and the closed-end type, or veterinary care merchant pharmacies). 2. Latvia controlled narcotic substances, psychotropic substances and precursors of substances in list II, medicinal products and veterinary medicinal products (hereinafter referred to as list II substances and medicines) and Latvia controlled narcotic substances, psychotropic substances and precursors in substances in list II, medicine and veterinary medicine (hereinafter list III substances and medicines) movement allowed if: 2.1. substance, drug or the manufacturer of the veterinary medicinal product (hereinafter referred to as substance or drug company) has received special permission (license) of the substance , medicine or veterinary medicine production or import, and its annex are indicated in the special conditions of operation-psychotropic medication or veterinary drug production or manufacture of narcotic drugs and psychotropic medicines recognized or the manufacture of veterinary medicinal products, as well as having commanded of the officials responsible for the II or III substances included on the list, medicine or veterinary medicine production and circulation of enforcement;
2.2. the medicine or veterinary medicine lieltirgotav (pharmaceutical wholesaler) has received special permission (license) veterinary medicinal products or medicinal products to open lieltirgotav (operation) (hereinafter referred to as the drug lieltirgotav) and its annex are indicated in the special conditions of operation-psychotropic medicine or veterinary medicine distribution, or manufacture of narcotic drugs and psychotropic medicines recognized or the distribution of veterinary medicinal products, as well as having commanded of the officials responsible for the II or III substances included on the list or order of the circulation;
2.3. General types of Pharmacy (medicine retailers) or type of Pharmacy has received special permission (license) to open a drugstore (operation) and its annex are indicated in the special conditions of operation-psychotropic drug distribution, or manufacture of narcotic drugs and psychotropic medicines recognized distribution is commanded of the officials responsible for the II or III substances included on the list or order of the circulation. 3. The rules referred to in paragraph 2, the parties (hereinafter the licensee): 3.1 develop and approve internal regulations or equivalent document, which according to the profile and structure of the work determines the detailed procedure for implementing these provisions;
3.2. designate the officials responsible for list II or III substances or medicines, or intermediate, and unusable residues, which are included in list II and III substances (hereinafter referred to as the products), the circulation of the order (hereinafter referred to as the designated officer), and, where necessary, designate the officials responsible departments;
3.3. designate the official or officials responsible during her absence are entitled to list II or III substances or medications. II. list II and III substances and drug manufacturing, purchasing and receiving 4. Substance or drug manufacturer shall ensure that the production and control operations are clearly defined and consistent with the European Commission's guidelines for good manufacturing practice of medicinal products, as well as legislation on medicinal products or the manufacture of veterinary medicinal products and control requirements. 5. the manufacturer of the medicinal product or substance in addition to the legislation on medicinal products or the manufacture of veterinary medicinal products and control requirements documentation system also includes instructions for specific actions in relation to (II) and (iii) the list of substances and drug production, drug, substance and product storage, tracking and destruction. 6. the substance or drug manufacturer for list II or III substances and drug manufacturing operation or control switch with only the persons who have received the appropriate special permission (license) or permission actions by list II or III substances. 7. the substance or drug manufacturer and lieltirgotav of medicines included in list II and III substances and medicines purchased, received, distributed and issued pursuant to these rules and regulations on medicinal products or wholesale distribution of veterinary medicinal products in the construction. 8. the pharmacy list II and III substances and medicines purchased, received, distributed and issued pursuant to these rules and regulations on medicine or veterinary medicine distribution to retail. If the special permissions (licenses) to open a drugstore (action) is not listed in the annex to the special operating conditions – manufacture of medicines, pharmacy buy only finished dosage forms. 9. list II and III substances and medicines are entitled to only the designated officer or officers, as indicated in paragraph 3.3 of these regulations. 10. the responsible officer provides: 10.1. II and III substances included on the list and the request and the presentation of invoices (in paper form, electronically or in any other form) separately from other drug requests and deliveries;
10.2. list II and III substances and drug demand and inventory and storage of invoices, separate from other requests and deliveries;
10.3. for recipes, for which issued, (II) and (iii) included in list Hall, store separately from other recipes. III. II and III substances included on the list and the accounting officer and 11 of these regulations 3.2. officials referred to departments data on list II substances and drug purchasing, receiving, distribution, manufacturing, and disposal of working days recorded during the illicit manufacture of narcotic drugs and psychotropic substances recognized and mandatory log (hereinafter mandatory magazine). Mandatory log also recorded data on the manufacturing process of the products obtained, containing list II substances. Mandatory log confirms the officer with a signature and a personal stamp, if any, and the licence holder's seal. Log on the last page, indicates the date on which the first and last record. The manufacturer of the medicinal product or substance and drug lieltirgotav the mandatory log of equipment in accordance with the provisions of annex 1, the pharmacy in accordance with the provisions of annex 2. 12. the mandatory log records also list II substances, medicines and products, in pure form or mixed with substances following indiferent III substances included on the list: 12.1. ephedrine;
12.2. pseudo;
12.3. the St.Johns;
12.4. triheksifenidil;
12.5. GHB (sodium oksibutirāt and lithium-oksibutirāt). 13. the responsible officer and the rules referred to in point 3.2 executive departments data on the substances in list II, medicines and products, production, distribution, receipt, and the destruction of working days recorded during the mandatory log or using electronic or other data processing system. When you register for the recipient shall provide the data or the supplier, the date of the transaction, the name of the medicinal products or substances, or received, issued, delivered or disposed of, or (iii) the list of medicinal products, or product name, quantity, (iii) the list of substances included in percentage, and (iii) the quantity of the substance in the list. 14. If the record is mandatory in the journal is flawed, it is deleted so that you can see the initial contents of the entry. Next to the correct entry and shall indicate the date when the correction. Entry with signature and personal stamp (if any) certifies the reviewer and records officer. 15. the responsible officer once a month, check the II and III substances included on the list and accounting procedures of the medicinal product: 15.1 compares mandatory log registered list II and III substances and medicines, as well as (II) and (iii) substances included in the list of the products in the balance with the actual balance. The results of the checks carried out strict accounting journal entries, specifying the date of the check, and the record is certified by signature and personal stamp (if any);

15.2. If the substances in list II, and (iii) the list of medicinal substances in the product registration is carried out electronically or by using a different data processing system, data printout for the period and compare the registered substance, and (iii) the list of medicinal substances in the product with the actual substance of the balance, and the balance of the medicinal product. The output data and the designated officer confirms with a signature and personal stamp (if applicable). 16. Strict accounting journal (after the last entry) and 15.2 these rules referred to in print for 10 years. 17. If the holder of the licence included in list II and III substances released or used in medicine or the manufacture of veterinary medicinal products or substances are permitted for losses up to 0.5% of the weight of the substances used. Weight loss rules apply only if it is established by actual shortages of the substance. 18. Annexes II and III to found on the list of substances included in the actual weight loss officer shall draw up the instrument. For the substances in list II and paragraph 12 of these regulations the substances listed in the actual weight loss take a mandatory entry in the journal. For the substances in list II are the actual weight loss take a mandatory entry in the journal, or using other electronic data processing system. The record shall be made pursuant to paragraph 13 of these regulations. The Act of signing the license holder (sole proprietor or company Board Member who is entitled to represent the company) and officer. Signatures verified by the stamp of the licence holder and the responsible personal stamp (if applicable). 19. the health inspection, carried out a check on (II) and (iii) the list of substances and medicine circulation order, also check this rule 15.2. prints and referred to mandatory roster. Log on the last page, indicates the date of the check. Checks the health inspection officials certify with signature and personal stamp. IV. (II) and (iii) list of substances and drug storage 20. list II and III substances, medicines and products in a separate room or a room that is placed in a lockable cabinet, metal cabinet or safety deposit box. The room is not permissible free of movement of persons. Medications stored under the drug label and instructions for use under certain storage conditions as well as the legislation on medicinal products and distribution of veterinary medicinal products. 21. the substance or drug manufacturer and lieltirgotav of list II substances, medicines and products in a separate room, metal cupboard, fixed to the wall or floor, or safety deposit box. Separate room, metal filing cabinet or safe deposit box shall be equipped with an alarm. Alarm connected to centralized security network. 22. The Pharmacy list II substances and medicines in a separate room or safe, or metal cupboard, fixed to the wall or floor. A separate space, a safe deposit box or metal cabinet shall be equipped with an alarm. Safety deposit box or the metal closet placed in a separate room or storage space, or for the manufacture of medicinal products, or pharmacy (pharmacy Branch) leader's Office. Pharmacy (pharmacy Branch), in which, in accordance with the laws and regulations on the opening and operation of pharmacies not pharmacy (pharmacy Branch) the driver's wallet or metal filing cabinet can be placed in the room of the goods receipt. 23. the substance or drug manufacturers, drug lieltirgotav or pharmacy list III substances, medicines and products stored in lockers, cabinets, separately from other substances, medicines and products. Medications stored under the drug label and instructions for use under certain storage conditions as well as the legislation on medicinal products and distribution of veterinary medicinal products. 24. the substance or drug manufacturer premises which produced the list in II and III substances and medicinal products shall be equipped with an alarm that is connected to the centralised security network. 25. The holder of the licence 3.1. these provisions in the document referred to in subparagraph States: 25.1. persons who have the right to enter these rules 20, 21, 22 and 24, paragraph premises;
25.2. the order in which the room or closet, or the metal safe deposit box lock at the end of the working day, or sealing the seal and turn on the alarm;
25.3. the key storage. V. II and III substances included on the list and the issuance and distribution of the medicinal product 26. Officer shall ensure that: 26.1. dissemination of list II and III substances and medicines, each consignment shall be accompanied by a packing slip (in paper form, electronically or in any other form). Note indicates information according to the legislation on medicinal products or distribution of veterinary medicinal products;
26.2. the packing slip included in list II and III substances and medications listed separately from other substances and drugs;
26.3. list II and III substances and medicines distributed, only those individuals who have received the rules referred to in paragraph 2 of the special permission (license), medical institutions, social care institutions, practicing veterinarians and the veterinary care of merchants under the scope of pharmaceutical and veterinārfarmācij regulatory law are entitled to purchase a list II and III drugs. 27. The holder of the licence 3.1. these provisions in the document referred to include precautionary measures to ensure that the list II and III substances, medicines or products, transport or move between departments, were not stolen or burglarized. 28. the substance or drug production or manufacture of the required list II and III substances officer or 3.3 of these regulations referred to officials issued pursuant to the provisions referred to in subparagraph 3.1 the procedures described in the document. 29. The patient or the treatment of the animals necessary in list II and III drugs only be issued against the prescription issued in accordance with the legislation on veterinary prescription and recipes. 30. Medical authority, veterinary care, veterinary care authority operator, a practicing veterinarian and the institution of social care pharmacy included in list II and III drugs only be issued against the request. Note presented according to this provision, paragraph 10, and 26.1. the requirements referred to in point. 31. The recipe prescriptions included in list II and III drug substitution is permitted only if the following conditions are fulfilled: 31.1. doctor has indicated that the discharged medicine must not be replaced;
31.2. the active substance is a medicinal product identical prescriptions for the active substance;
31.3. the pharmaceutical form is identical to the form of prescriptions;
19.5. the doses of medicines is appropriate, multiple or simple expandable according to the doses of prescriptions;
31.5. for medicinal products granted total dose does not exceed a total dosage of prescriptions;

19.6. the patient is informed and agrees to receive the medication with a different name (synonym). 32. the issue of list II and III included in the medicines to the pharmacist or the pharmacist, the recipes, the Assistant indicates the name of the medicinal product, the dosage, quantity, date of issue and sign on. Signature by the personal stamp (if applicable). 33. it shall be prohibited to issue (II) and (iii) the list includes medicines against prescriptions, which the presentation does not conform to the laws and regulations on prescription. These recipes retain the pharmacy. If you suspect that a recipe is a false issued before medicine pharmacist will contact the medical treatment person recipe vis-a-vis. 34. at the end of the working day Pharmacies recorded the provision referred to in paragraph 33 recipes not designed for prescription accounting journal (annex 3). The designated officer shall be submitted at the end of the quarter the health inspection information on treatment of persons who signed the prescription, and indicate the physician name, specialty, hospital and mistakes. 35. Not relevant-looking recipes stored separately from other recipes. 36. Pharmacy Manager or responsible persons are obliged to report to the health authorities about the recipes, as well as in suspicious cases, where there is doubt concerning the unjustified (II) and (iii) the list of medicinal products on prescription or prescribing appropriate treatment services, veterinary care, veterinary medical care in the merchant, practicing veterinarians, or social care institutions discharge a request. Health Inspectorate shall immediately inform the food and veterinary service, if such suspicious cases or doubts arose about undue (II) and (iii) the animal on the list of medicines for the treatment of discharge to recipes or veterinary care, veterinary medical care in the merchant or persons engaged in veterinary medical practice, request. 37. If the OTC product contains list II and III substances, a patient allowed to issue no more than one secondary packaging. 38. The medication containing buprenorphine, issue, if the patient submits a recipe and show an identity card and the patient's substitute buprenorphine therapy program card (annex 4), in which the person committed a record of treatment for medicine. The pharmacist or the pharmacist's Assistant when issuing drugs containing buprenorphine, buprenorphine substitution therapy patient programs map indicates the quantity of the medicinal product, the date, the name of the medicine pharmacy vendor name, qualifications and record confirmed by signature and personal stamp (if applicable). 39. Against prescription pharmacy service to the prohibited means of narcosis: 24.3. GHB (sodium and lithium oksibutirāt osksibutirāt);
24.4. fentanyl injection solution;
39.3. diethyl ether. Vi. Quality of the II and III substances included on the list and the destruction of 40 quality Not included in list II and III substances and products (hereafter referred to as low grade medicines) until their destruction in a separate space, separated space or package, eliminating the chance to mess with quality products. Poor quality medicines stored according to these rules 20, 21, 22 and 23 of those requirements. 41. the quality of the medicinal product that is not transferred back to the supplier, destroy licensee-created Commission (minimum three people) presence in accordance with the regulations on hazardous waste requirements or the contract for the management of hazardous waste to a person manage hazardous waste and has received appropriate permission. 42. For the quality of medicines return to the supplier or the transfer of the management of the hazardous waste referred to in paragraph 41 of the rules, the Commission shall draw up a transfer and acceptance. The Act specifies the members of the Commission of the names and position, the reason for the destruction of the substance, drug or product name, quantity, manufacturer, the II and III substances on the list content and total quantity. Drugs in addition to indicate the pharmaceutical form, strength of the medicinal product, the production serial number, the manufacturer of the medicinal product. Act shall be drawn up in duplicate and signed by all the members of the Commission. One copy within three days of sending health inspection, the other copy of the holder of the licence for 10 years. 43. the quality of the medicinal product destruction or transfer of dangerous waste management made mandatory for the entries in the journal and the destruction or indicate surrender and acceptance report number. VII. list II and III substances and drug shortage or surplus of 44. If found in II and III substances included on the list of medicines or products, shortage or surplus happened in crime or loss incurred as a result of force majeure, or wallet, or metal cabinet, or lockable closet sealed and secured against unauthorised access. On the licensee or designated officer shall immediately notify the State Police (except in the case where damages are due to force majeure) and health authorities. 45. following these rules referred to in paragraph 44 of the fact finding for the licensee to immediately establish a Commission composed of at least three people. Panelists include: 45.1. the licence holder or his authorized officer;
45.2. the officials responsible. 46. This provision, the Commission referred to in paragraph 45, health inspection by the representative or national police representative (if the crime occurred) Act shall be drawn up on list II and III substances, medication or product shortages or surpluses. The Act specifies the Act of dialing location and date, members of the Commission of the name and job title, substance, drug or product name, (II) and (iii) the list of substances included in the content and the products and total quantities in addition specify the pharmaceutical form, strength of the medicinal product, the production serial number, the manufacturer of the medicinal product. Legislation signed by all the members of the Commission and by external health inspections, or the national police. 10 years of the legislation. 47. (II) and (iii) substances included on the list, and product shortages or surpluses also tracks the mandatory log and noted that rule 46 of the Act referred to in paragraph number. VIII. Licensee's obligations and control 48. licensee shall ensure: 29.9. II and III substances included on the list and the production and circulation of medicines in accordance with these rules, other laws and regulations for the illicit manufacture of narcotic drugs and psychotropic substances circulation, as well as the pharmaceutical or veterinārfarmācij areas of regulatory law;
30.0. II and III for all the substances included on the list and the medicine production and circulation of documentation of activities, providing the ability to track every action related to such substances or medicines or products;
48.3. the health inspection officials free access to the sites that are related to (II) and (iii) the list of substances or drugs, or the production and movement of products, and all documents associated with it;
30.1. to list II and III substances and medicines do not get illegal circulation;
30.1. the data on II and III substances included on the list, and the production and movement of products, as well as at the request of the Inspectorate of health made a statement (in paper form, electronically or in any other form) of not less than 10 years. Extracts the data and approve the officer with a signature and personal stamp (if applicable). 49. the substance or drug manufacturers and drug lieltirgotav State Agency of medicines shall submit the following information on the II and III substances included on the list and the movement of medicinal products: 30.5. quarterly report (submitted 15 days after the end of each quarter). Quarterly report indicates the information in accordance with the provisions of annex 5;

30.6. the report for the previous calendar year (hereinafter referred to as the reporting year) (submitted by 15 February). The information in the report in accordance with the provisions of annex 6 and provides a summary of the reporting year, manufactured, imported exported volume of medicinal products compared to the volume of the medicinal products concerned in the previous year, as well as the assessment of growth or decay. 50. the substance or drug manufacturer and lieltirgotav of medicinal products by the Ministry of health, health inspections and the State Agency of medicines shall deliver the request for information about a specific list II and III substances and drug distribution within the period specified in accordance with the provisions of annex 6. 51. A pharmacy not less frequently than once a month in accordance with the agreement concerning the specific prescription data processing provides information health compulsory insurance State Agency for medicinal products, drawn to the special prescription forms. 52. the State Agency of medicines and health compulsory insurance State Agency provides the information in their possession to the Ministry of Health and health inspection according to the demand of the II and III substances included on the list and the movement of medicinal products. The food and veterinary service of the alleged infringements (II) and (iii) the list of substances and medicine circulation report to the health authorities. 53. the health inspection shall immediately inform the food and veterinary service, if there is a suspicious cases or questions about the treatment of animals without justification annexes II and III to the list of medicinal products discharge to recipes or veterinary care, veterinary care of the Authority's or persons engaged in veterinary practice, the request form. 54. the health inspection check list II and III substances and medicine movement: 54.1. General types of pharmacies and closed type pharmacies, not exceeding two years;
54.2. lieltirgotav medicinal products – not less frequently than once a year.
55. the State Agency of medicines shall check list II and III substances and drug manufacturing: 55.1. not exceeding two years where it is produced in list II substances and drugs;
54.2. not less frequently than every three years, if it is included in list III of the produced substances and medicines. Prime Minister i. Godmanis Health Minister i. Morris annex 1 Cabinet 17 June 2008. Regulations No 441 to the illicit manufacture of narcotic drugs and psychotropic substances recognized and mandatory substances or pharmaceutical journal, or in the manufacture of veterinary medicinal products or medicinal or veterinary medicine lieltirgotav Health Minister i. Morris annex 2 Cabinet 17 June 2008. Regulations No 441 to the illicit manufacture of narcotic drugs and psychotropic substances recognized and mandatory journal pharmacy in Health Minister i. Morris annex 3 of the Cabinet of Ministers of 17 June 2008 on the Regulation No. 441 of recipe not fit-looking accounting journal Health Minister i. Morris annex 4 of the Cabinet of Ministers of 17 June 2008. Regulations No 441 Health Minister i. Morris annex 5 cabinet 17 June 2008. Regulations No 441 overview of II and III substances included on the list and the receipt, issue, purchase, disposal and _____ of _____ quarter Health Minister i. Morris annex 6 Cabinet 17 June 2008. Regulations No 441 overview of II and III substances included on the list and receive the buying in and out _ _ _ _ _ _ _ _ _ the Health Minister Morris I.