The Illicit Manufacture Of Narcotic Drugs And Psychotropic Substances And Drug Purchasing, Receiving, Storage, Distribution, And Accounting Procedures Of The Medicinal Plants, Herbal Lieltirgotav And Pharmacies

Original Language Title: Narkotisko un psihotropo vielu un zāļu iepirkšanas, saņemšanas, uzglabāšanas, izplatīšanas, izsniegšanas un uzskaites kārtība zāļu ražošanas uzņēmumos, zāļu lieltirgotavās un aptiekās

Read the untranslated law here: https://www.vestnesis.lv/ta/id/103607

Cabinet of Ministers Regulations No. 168 in Riga, 8 March 2005 (pr. No 13, § 31) illicit traffic in narcotic drugs and psychotropic substances and drug purchasing, receiving, storage, distribution, and accounting procedures of the medicinal plants, herb and pharmacy 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 i. General questions 1. determines the order in which the substances included in Latvia controlled narcotic substances, psychotropic substances and precursors in list II and III and medicinal products containing those substances (hereinafter referred to as listed substances and medicines), receiving, purchasing, distributing, issuing, stored and accounted for medicinal plants, herbal lieltirgotav and pharmacies (hereinafter referred to as the company).
2. Latvia controlled narcotic substances, psychotropic substances and precursors list II substances and medicinal products (hereinafter referred to as list II substances and medicines), and (iii) the list of substances and medicinal products (hereinafter referred to as the list of substances and III drugs) may receive, purchase, distribute and store only a person who has received the appropriate special permission (license) the pharmaceutical activity in the annex which contains the special operating conditions – psychotropic drug distribution, or manufacture of narcotic drugs and psychotropic medicines recognized distribution (hereinafter person).
3. the Person responsible for the lists of substances and drug distribution, purchase, receipt, delivery, storage and accounting of the company in order and necessary arrangements for listed substances and drugs do not get to the illegal movement and would not be used illegally or used for other purposes.
4. the order in which a particular detailed this rule order, as well as the company's Executive, which is responsible for the lists of substances and drug distribution, purchase, receipt, delivery, storage and accounting order (hereinafter referred to as the responsible executive) company, the responsible business units (branches), as well as officials of the eligible lists substances and drugs officers absence. If your company is working in multiple shifts, indicate the responsible Executive in each shift. With the signature of a responsible officer certifying that he has read the order.
5. the Parties shall ensure that the presence of the official of the company national pharmaceutical inspection inspectors have free access to the substance and drug distribution, purchase, receipt, delivery and storage space, and all related documents, as well as the rules referred to in paragraph 4 of the order.
II. the lists of substances and drug purchasing and receiving 6. Pharmacy, where special permission (license) to open a drugstore (action) is not specified in the annex, that allowed the manufacture of medicinal products in pharmacies, buy only finished dosage forms.
7. the competent authority shall ensure that: 7.1.  lists of the substances and medicines, request and invoice-invoicing separately from other requests and invoices-invoices;
7.2. the lists of substances and drug demand and slip-invoice tracking and storage of medicinal products separate from other requests and invoices-invoices;
7.3. the prescription, to whom issued lists II and III drugs, storage separately from the other recipes.
8. list II and III substances and medications are eligible to receive only the officials specified in paragraph 4 of these provisions in that order.
9. List II substances and drug requests and invoices-invoices stored for at least ten years, (iii) the list of substances and drug requests and invoices-invoices stored in at least five years.
III. Lists of substances and drug records 10. data for Establishments in list II substances and drug purchasing, receiving, distributing and dispensing days recorded during the illicit manufacture of narcotic drugs and psychotropic substances recognized and mandatory log (hereinafter mandatory magazine), which pages are numbered and cauršūt. Mandatory log confirms with company managers and officials responsible for the signature and company stamp. Log on the last page, indicates the date on which the first and last record. Pharmaceutical company 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.
11. Mandatory log also recorded its medicinal products or in mixtures with substances containing such indiferent III list: 11.1. ephedrine;
11.2. pseudo;
11.3. St.Johns;
11.4. triheksifenidil;
11.5. GHB (sodium oksibutirāt and lithium-oksibutirāt).
12. the mandatory log also recorded it for the manufacture of medicinal products and pharmaceutical substances intended movement, whose records of certain mandatory logbook in accordance with the laws and regulations governing the distribution of medicinal products.
13. Company entries in the journal shall be made mandatory in accordance with the rules referred to in paragraph 4 of the procedures laid down in the order. If the entry is incorrect, it is deleted so that you can see the initial contents of the entry, next to the article the correct, indicate the date when the correction, and the record is certified by signature and personal stamp.
14. data on the substances in lists III and drug purchasing, receiving, issuing, distribution and records the mandatory log or using electronic, photographic or other data processing system. The company provides data storage for not less than five years, as well as the statement by the national pharmaceutical inspection request. Extract data and confirm with the responsible and personal signature stamp.
15. the responsible officer once a month, check the substances in list II and III and medicine records: 15.1 compares mandatory substances registered in the journal and the balance of the medicinal product with the actual substance and balance of the medicinal product and of the results of the checks carried out strict accounting journal entries, indicates the date of the check and record certified by signature and personal stamp;
15.2. If list III substance and drug registration is carried out by means of electronic, photographic or other data processing system, extract the data for the period of time and compare the registered substance and balance of the medicinal product with the actual substance and balance. Data extract data, and officer confirms with a signature and a personal stamp.
16. Strict accounting journal (after the last entry) and 15.2 these rules referred to in print in ten years.
17. The company, which listed in (II) and (iii) substances used in the manufacture of medicinal products, the substance loss up to 0.5% of the quantities of substances used. Loss provisions apply only where it is established by actual shortages of the substance.
18. The Pharmacy where the manufacture of the medicinal product used in list II and III substances, the levels of the substance loss calculated in accordance with the requirements of the laws on drug production. Loss provisions apply only where it is established by actual shortages of the substance.
19. (II) and (iii) found on the list of substances included in actual loss officer draws up laws and mandatory entry in the journal, in accordance with the provisions of section 15.1. On list III of the substances included in the actual loss shall be drawn up. The Act of signing officer and the head of the company and confirms the company's stamp.
20. national pharmaceutical inspection, making the company a check of the lists of substances and drug records, a mandatory log on the last page, indicates the date of the inspection, the Inspector with a signature and a personal stamp.
IV. Lists of substances and drug storage area in which 21 stores listed substances and medicines against unauthorised entry and looting.
22. the pharmaceutical company and lieltirgotav of medicines and substances in list II drugs stored in a metal cupboard, fixed to the wall or floor, or safe, or in an array in a separate room. Safe deposit box or metal wardrobe shall be fitted with sound or light alarm and placed in a room secured against unauthorised entry and looting. A separate room shall be equipped with an alarm that is connected to the centralised security network, and ensures the label and instructions for use under appropriate storage conditions.
23. The Pharmacy and of the substances in list II drugs: 23.1. stored in a vault in an array or a metal cupboard, fixed to the wall or floor. Safe deposit box or metal wardrobe shall be fitted with sound or light alarm;
23.2. the wallet 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 receipt of the goods;
23.3. the room where the safe deposit box or the metal closet, secured against unauthorised entry and looting.
24. This provision of the order referred to in paragraph 4 shall determine: 24.1. persons who have the right to enter this provision 22, paragraph premises;
24.2. 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;

24.3. the key storage.
25. The Pharmacy banned list II substances and drug storage in the visitor service Hall.
26. Company to list II substances and medications stored in cupboards, lockers, separate from other medicinal products, subject to the labelling of the medicinal product, in the operating instructions and the regulations on the distribution of medicinal products.
27. the substances in list II and III and the movement of medicinal products within the territory of the company outside of medicine storage facilities allowed only to outsiders would not be able to access the list of II and III substances and drugs, as well as ensuring appropriate security measures.
28. Pharmaceutical company premises in producing the substances in list II and III and medication, shall be equipped with an alarm that is connected to the centralised security network.
V. lists of substances and drug dispensing and distribution 29. Pharmaceutical company and the medicine of the lieltirgotav officer shall ensure that the distribution of substances in list II and III and halls, each consignment shall be accompanied by the packing slip-invoice list II and III substances and medications listed separately from other substances and medicinal products and that contains the information according to the laws and requirements for the distribution of medicinal products.
30. the pharmaceutical company and the drug lieltirgotav, which distributes the substances in list II and III and medicines, is responsible for the provision of security measures in the transport of substances and medicines. Drug carrier introduces the pharmaceutical company or a medicine prepared by the lieltirgotav instruction on the necessary precautions to substances and medicines do not get moving illegal circulation or burglarized. After the accident, transport cargo carrier of the obligation to notify immediately the police state, and company executive.
31. for the manufacture of medicinal products or the production of substances in list II and III shall be issued in accordance with the laws and regulations on the manufacture and distribution of medicinal products, as well as the rules referred to in paragraph 4 of the order.
32. The patient (II) and (iii) the list of medicinal products shall be issued only against prescription, drawn to the special recipes form in accordance with the laws and requirements of the prescription.
33. The recipe (II) and (iii) the list of prescriptions drug substitution is permitted only if the following conditions are fulfilled: 33.1. doctor has indicated that the discharged medicine must not be replaced;
33.2. the active substance is a medicinal product identical prescriptions for the active substance;
33.3. the pharmaceutical form is identical to the form of prescriptions;
33.4. the drug doses is appropriate, multiple or simple expandable according to the doses of prescriptions;
33.5. for medicinal products granted total dose does not exceed a total dosage of prescriptions;
20.9. substitution treatment is consistent with a person who asserts a recipe;
20.9. the patient is informed and agrees to receive the medication with a different name (synonym).
34. On the recipes, to which the issue of list II and III drugs, the pharmacist shall indicate the name of the medicinal product, the dosage, quantity, date of issue and sign on. The signature confirms with a personal stamp.
35. it shall be prohibited to issue (II) and (iii) the list of medicines against prescriptions, which the design does not meet the regulations on prescription requirements. These recipes retain pharmacy. If you suspect that a recipe is a false issued before medicine pharmacist is obliged to contact the medical treatment person recipe vis-a-vis.
36. at the end of the working day Pharmacies recorded this provision in paragraph 35 recipes not designed for prescription accounting journal (annex 3). The designated officer shall be submitted at the end of the quarterly period and the availability of medical care quality control inspection information on treatment of persons who signed the prescription, and indicate the physician name, specialty, hospital and mistakes.
37. the inappropriate-looking recipes stored separately from other recipes.
38. Drugstore employees are obliged to report to the Ministry of Health, the national pharmaceutical inspection and State Agency of medicines of the counterfeit prescriptions, suspicious cases, as well as in the event of doubt as unreasonable (II) and (iii) the list of medicinal products on prescription or prescribing treatment services (including medical practice) and the institution of social assistance request form.
39. the pharmacy issue list II and III drugs treatment authority (physicians also practice) and the institution of social assistance only to complete the request according to the laws of distribution of medicinal products. Invoice-invoicing presented according to this provision in paragraph 29.
40. If the OTC product contains list II and III substances, a patient allowed to issue no more than one secondary packaging.
41. The medication containing buprenorphine, issue, if the patient submits a recipe and buprenorphine substitution therapy patient programs map (annex 4), in which the person committed a record of treatment for medicine. The pharmacist 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 and qualifications and record confirmed by signature and personal stamp.
42. Against prescription pharmacy service to the prohibited means of narcosis: 42.1. GHB (sodium and lithium oksibutirāt osksibutirāt);
26.2. the injection of fentanyl solution;
26.3. diethyl ether.
Vi. the quality of the lists of substances and the destruction of 43. medicinal products quality in list II and III substances and medicinal products (hereinafter 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 in accordance with these rules 21, 22, 23, 24, 25 and 26 the requirements set out in paragraph.
44. without quality medications that are given back to the supplier, destroyed by order of the head of the company created a Commission (at least three people) presence in accordance with the laws and requirements of the hazardous waste or contracts the management of hazardous waste to a person manage hazardous waste and has received appropriate permission. On the quality of medicinal products and the transfer of the substances present and the acceptance of the transfer Act. The Commission shall include the national pharmaceutical inspection or State police representative.
45. This provision is referred to in paragraph 44, the Commission shall draw up legislation on medicinal products or substances for destruction or surrender and acceptance report indicating the name of the medicinal product, the serial number, quantity, the destruction of reason, the members of the Commission of the name and job title. Legislation drawn up in two copies, signed by all the members of the Commission. One copy to be sent within three days of the national pharmaceutical inspection. The legislation is kept for a period of five years.
46. On the destruction of records shall be made mandatory in the log and specify the transfer and adoption of Act or acts.
VII. the lists of substances and medicine shortage, theft, robbery or loss of the disaster will be 47. If the found substances in list II and III and the drug shortage or surplus, theft or robbery took place or where the losses resulted from natural disasters, space and safety sealed and secured against unauthorised access. On the Enterprise Manager or the designated officer shall immediately notify the State police and the national pharmaceutical inspection.
48. following this rule 47, paragraph fact finding of the head of the company immediately to the order established by the Commission. The Commission is made up of: 29.9. company Manager or his authorized officer;
48.2. the responsible officer;
48.3. the national pharmaceutical inspection agent.
49. The provision referred to in paragraph 48, the Commission shall draw up on list II and III substances or drug shortage or surplus. The Act specifies the Act of dialing location, and the date, the name of the medicinal product, pharmaceutical form, strength of the medicinal product, the serial number of the production quantity, a drug company, the members of the Commission of the name and job title. Legislation signed by all the members of the Commission. The legislation is kept for a period of five years.
50. (II) and (iii) the list of medicinal products shortage or surplus, theft or robbery, as well as damages due to natural disasters also tracks the mandatory log and specify the rules referred to in paragraph 49 of the Act.
VIII. Organization and responsibilities of the institutions 51. Pharmaceutical company and the lieltirgotav State Agency of medicines shall be submitted the following information on the II and III substances included on the list and distribution of medicinal products: 51.1. the quarterly review (must be submitted within 15 days after the end of each quarter), showing the information in accordance with the provisions of annex 5;
51.2. report for the previous calendar year (must be submitted before 15 February), the information in accordance with the provisions of annex 6;
51.3. the assessment for the previous year, manufactured, exported the imported volume of medicinal products compared to the volume of the previous year and the reasons for the growth or reduction.

52. Pharmaceutical company and drug lieltirgotav by national Ministry of health, the pharmaceutical inspection and the State Agency of medicines of the request, provide information about a specific list II and III substances and drug distribution within the period specified in accordance with the provisions of annex 6.
53. 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.
54. the health compulsory insurance State Agency to the Ministry of Health provides quarterly reports on medicinal products (all information in the recipe), drawn to the special prescription forms.
55. the State Agency of medicines and health compulsory insurance State Agency shall provide the Ministry of Health and the State Pharmaceutical inspection according to request all necessary information on the substances in list II and III and the distribution of medicinal products.
56. This rule controls the national pharmaceutical inspection.
IX. final question 57.  (Iii) the list of medicinal products authorized to be issued against prescriptions issued to the Thai prescription forms to 30 June 2005.
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: the entry into force of the provisions by 16 March 2005.