Cabinet of Ministers Regulations No. 16 in 2016 (January 5. Nr. 1 24) amendments to the Cabinet of Ministers of 8 March 2005, regulations No. 175 "prescription form manufacturing and storage, as well as prescription and storage rules" Issued in accordance with article 60 of the law on medical treatment and the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" 36. the first paragraph of article 1 do cabinet 8 March 2005, regulations no prescription form for making 175 "and storage as well as prescription and storage rules "(Latvian journal, 2005, 48. No; 2007, nr. 104.; 2008, 22, nr. 87.; No, 60; 2011 2013, no. 208) the following amendments: 1. express the point 2 as follows:" 2. the prescription forms: 2.1. ordinary recipe where the statement about the full payment to be served Hall and medical devices, except those provisions referred to in point 2.2. The usual prescription electronically in a single electronic health information system (health information system) according to the legislation on the single health sector electronic information systems, or to the usual recipes form (annex 1); 2.2. the special recipe, which extract the narcotic drugs and psychotropic drugs, including drugs, which the State Agency of medicines have been found by the Narcotic analgesics for means, drugs which contain this provision 7. substances listed in the annex, as well as medicines and medical devices, the purchase of which the patient is compensated in whole or in part. Special prescription electronic health information system according to the legislation on the single health sector electronic information systems, or to specific recipes form (annex 2). '; 1.2. make 10 and 11 of the following paragraph: "10. Treatment Services Manager and is responsible for the form, the prescription and dispensing of medical people who worked in the medical institution, as well as the unused special prescription records storage and destruction, drawn to the prescription form and in accordance with the provisions of paragraph 25 of received from the patients (hereinafter referred to as the explosive recipe), and withdrawn from circulation prescription form and transfer the accounts service When writing about the transfer. 11. in order to ensure the prescription form and movement control authority, special services and a form of prescription medical institution registered special prescription form log. Special prescription form log sample determines the Service Director and the hospital's Manager. Special prescription form log completed not less frequently than once a week. " 1.3. adding to paragraph 20 of the agenda after the words "as well as" with the words "not less frequently than once every quarter; 1.4. the express 24 as follows: "Scrapped and 24 withdrawn from circulation prescription forms service, damaged prescription forms, and unused prescription medical institution destroyed the service or treatment services manager created a Commission (minimum two people). On the prescription form or prescription shall act of destruction, showing the destroyed or prescription form prescription form, series, number, quantity, location, date of disposal, disposal, other destruction related conditions, as well as members of the Commission (name and title). Legislation signed by all the members of the Commission. Act appropriate service or medical institution shall keep for a period of three years. '; 1.5. to complement the 25 point after the words "unused special recipes" with the words "issued to special recipes form"; 1.6. to supplement 27 behind the words "repeatedly used the recipe" with the words "drawn to the usual recipes form"; 1.7. to express points 29 and 30 by the following: "29. Prescription electronic health information system according to the legislation on the single health sector electronic information systems, or on a certain sample forms (annexes 1 and 2), subject to this chapter, the specific arrangements for the prescription and the rules referred to in annex 3 of the prescription filling requirements. When the recipe for electronic health information system, in addition to also comply with the rules set out in chapter III1 prescription order health information system. Only to determine the form of the sample prescription: 29.1. is used for medical devices, medicinal products or list individual M of eligible products according to the regulations for outpatient treatments and medicines for the purchase of medical equipment for compensation procedures (hereinafter referred to as the compensation procedures); 29.2. the patient is informed that the recipe will be used in another Member State of the European Union, a European economic area country or the Swiss Confederation; 29.3. the recipe is drawn person, which is not registered in the population register; 29.4. doctor who do not work in the medical institution, extract medicines for personal use; 29.5. recipes out health information system is not possible for technical reasons, the health information system is available, the doctor's practice is electricity or internet connection disruption or health information systems are not able to access during home visits and medicines or medical devices patient needs immediately; 18.4. the purchase of medicines the patient is compensated for by an insurance company. 30. The recipe on a certain sample forms clearly legible handwriting the statement or the use of a computer or other technical means, which provides clear and unambiguous data perception. Medical person to receive and store prohibited prescription forms, which indicates the name of the medicinal product. Recipes properties, and text is clearly legible and indelible. When the recipe is not acceptable errors and corrections. "; 1.8. make 32, second sentence as follows: "the doctor who did not work in the medical institution, allowed to discharge grass onto the usual recipes only for personal use, but not more than 50 recipes a year."; 1. replace paragraph 33, the words "consistent with the laws of the outpatient treatments and medicines for the purchase of medical equipment for compensation procedures (hereinafter referred to as the compensation procedures)" with the words "appropriate compensation procedures"; 1.10. Express 21.3 points as follows: "drugs, which contain 21.3 these rules referred to in annex 7, the statement, subject to the registration certificate holder (owner) and developed with the State Agency of medicines of the agreed programme of prevention of pregnancy and the following conditions: 1. before treatment started 21.3 doctor make sure that the patient is familiar with pregnancy prevention program (according to sex and age, reproductive potential) and has signed the informed consent document; 21.3 2. medications containing isotretinoin, thalidomide, lenalidomīd and pomalidomīd, patients with reproductive potential may make no more than four weeks of treatment course. "; 1.11. to express point 35 the following: "35. If the doctor when the usual recipe, provides for the possibility of the patient medicine to buy on a regular basis, the volume of prescriptions to pharmacies receive the parts no more than once a month, a physician on the prescription indicates "course of treatment", and this recipe is considered renewable. If the recipe for ordinary recipes made out of form, "course of treatment" the doctor confirms with a signature and personal stamp. "; 1.12. the deletion of paragraph 36 and 37, the word "form"; 1.13. in paragraph 41 to make the first sentence as follows: "the alcohol or alcohol water solution for the issue of the treatment of the extract of normal persons."; 1.14. paragraph 44 be expressed as follows: "44. Recipe, which discharged the health information system, shall be approved in accordance with the laws and regulations on the single health sector electronic information system. The recipe, which is discharged to the usual forms of treatment prescription person confirms with a signature and a personal stamp. The recipe, which is discharged to the special recipes, in addition to the forms you need the medical authority (physicians can use the practice personal stamp, which includes medical practice properties). "; 1.15. to supplement the provisions of this chapter III1: "III1. Order prescription health information system

29.9 the health information system in accordance with the prescription of these provisions in chapter III and annex 3 prescription fill the requirements as far as they relate to electronic prescriptions. When the electronic prescription, the name of the medicinal product by choosing from the health information system the drug classifier, but by individual recipes make the composition of medicines and the medicines not registered in Latvia name indicate the health information system in the free text field. When the electronic prescription 30.0, physician or physician assistant (paramedic) patient prescription issued identification number. 30.0 to purchase electronic prescription medicines, prescriptions in person or pharmacist pharmacist Assistant displays the identification number of the recipes or identity documents. If the product purchased by the person to whom the prescription is not discharged, the pharmacist or the pharmacist Assistant displays the identification number of the recipe and name the name of the person who issued the prescription. If the named person's name does not match with the health information system the information available, the pharmacist or the pharmacist's assistant medicine shall not be issued. The pharmacist or the pharmacist's Assistant health information system indicates the name of the person, the name and ID of the person who purchased the electronic recipe prescriptions drugs. 48.4 the usual electronic recipe medicines the patient is discharged, the right to purchase a portion of both one and several pharmacies. 30.1 special electronic prescriptions, which discharged in Latvia controlled narcotic drugs or psychotropic medicines recognized, the health information system shall be kept for a period of five years, but the other special recipes health information stored in the system for three years. The usual recipes health information system stores a year. 30.2 the recipe does not issue prescriptions pharmacy medicines, the health information system is a message stating that the person to whom the prescription discharged is dead. 30.3 If the home visits during the health information system access is not possible, a physician or a physician's Assistant (feldšer) has the right to write electronic prescriptions, not later than the next working day, informed a patient visit. "; 1.16. replace paragraph 49, the words "If the drugs and medical devices" with the words "If the medical device and the list of medicinal products"; M 1.17. supplement with 30.5 and 30.6 point as follows: "If the medicinal product is discharged to 30.5 ordinary recipes form or on specific recipes form, except that rule 29.1. the cases referred to in a pharmacy in accordance with the laws and regulations on the single health system of electronic information online provides information about the medicine prescribed and issued. 30.6 When recipe discharged electronic health information system, the pharmacy in accordance with the laws and regulations on the single health sector electronic information system provides data on issued online. "; 1.18. the express section follows 50.2.: "50.2. following the Ministry of health, State Agency of medicines, health inspection and law enforcement authorities request provides information about recipes or for medicinal products granted of prescriptions and medical equipment consumption;"; 1.19. the deletion of 55.1 points; 1.20. supplement with 59, 60, 61 and 62 of this.: "59. Rule 30.5 and 30.6 points in 2016, will enter into force on 1 December. 60. data processing for obtaining health information system, but no later than 2016. November 30, doctor or physician assistant prescription only on the prescription form. 61. By 2016 November 30 prescription electronic health information system of the statement in the following order: complete all electronic recipe boxes provided on the case, and fill it to the usual printed recipes forms when discharged in a normal recipe, recipes or on special forms when discharged in a special recipe, confirmed by a signature and a personal stamp, but also with the specific recipe treatment authority (physicians can use the practice personal stamp that includes medical practice and issue the patient). 62. The recipes, drawn in accordance with paragraph 61 of these regulations, these regulations shall apply to the prescription laid down in chapter II in the form of manufacturing and storage procedures. '; 1.21. make informative reference to European Union directives as follows: "Informative reference to European Union directives, the regulations include provisions resulting from: 1) Commission 20 December 2012, the implementation of the directive in 2012/52/EU, laying down measures to facilitate the prescriptions issued in another Member State; 2) of the European Parliament and of the Council of 15 December 2010, the EU directive 2010/84/as regards pharmacovigilance of the European Parliament and the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. "; 1.22. deletion of annex 3, as well as in the title of chapter III of title II and the word "form"; 1.23. to complement annex 3 with 13.1 points by the following: "13.1 issuance of biological medicinal products, the pharmacist or the pharmacist's Assistant recipes form the other side, if the recipe to recipes out in the form, or the health information system, if the recipe out health information system, specify the medicinal products issued serial number. This information to the pharmacist or the pharmacist's Assistant recipes form certified by signature and personal stamp. "; 1.24. Express 3.17 the following: "17. For medicinal products granted code (registration number Latvia register of medicinal products, stating the product identification number) assigned by the manufacturer of the medicinal product or the name (including the packaging), quantity (number of packages), price (one Pack), to pay the estimated amount (taking into account the number of packages) and the date of the prescription indicates a pharmacist or pharmacist Assistant, issuing the medication. This information to the pharmacist or the pharmacist's Assistant recipes form certified by signature and personal stamp. "; 1.25. the supplement to annex 3, paragraph 18, after the word "recipes" with the word "form"; 1.26. Express 3. paragraph 23 of the annex by the following: "23. medicinal products issued identification (identification number of the medicinal product in the list of products eligible for compensation within the framework of the izplatāmaj drugs or drug registration number Latvia register of medicinal products with the product identification number – in other cases) or the name of the manufacturer (the name indicates, if the product is not included in the register of medicinal products, and add information about the size of the package), quantity (number of packages), price (one package) for payment amounts (taking into account the number of packages), its distribution between the patient and other persons, as well as the date of issue of the notes or the pharmacist the pharmacist's Assistant, which shall be issued by the medicines. This information to the pharmacist or the pharmacist's Assistant recipes form certified by signature and personal stamp. If the quantity is not to be served in full packages, package quantity indicates decimal numbers with precision up to four decimal places. " 1.27. deletion of annex 4, the text in point 3.7. "C10AX04 to publicise"; 1.28. the supplement to annex 7 of the regulations as follows: "Annex 7 of the Cabinet of Ministers of 8 March 2005, regulations No 175 active substances with high risks of Isotretinoin pharmacovigilance 1.2.3.4 Thalidomide Lenalidomīd. Pomalidomīd". 2. This rule 1.16 subparagraph shall enter into force in 2016, on 1 December. The Prime Minister is the Rapidity of the Newsletters Health Minister Guntis Belēvič in