Pharmaceutical Law Amendment

Original Language Title: Grozījumi Farmācijas likumā

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Read the untranslated law here: https://www.vestnesis.lv/op/2012/200.4


The Saeima has adopted and the President promulgated the following laws: pharmaceutical law do pharmacy Act (Republic of Latvia Saeima and the Cabinet of Ministers rapporteur, 1997, nr. 10; 1998, nr. 9; 1999, no. 2; 2000, no. 2, 13, 14; 2001; 2003, no. 9., 11; 2004, nr. 10; 2006, 2. No.. No; 2007; 2008 21 no, 12, no. 24; 2009, no. 8; Latvian journal, 2009, 200. no; 2010, no. 131, 183.) the amendments are as follows: 1. Article 1: Add to the article with the following point 1.1: ' 11) active substance: any substance or combination of substances intended for use in the manufacture of medicinal products and in the manufacture of medicinal products in pharmacies and medicine after use in the production or manufacture of these products becomes the active ingredients, the pharmacological, immunological or metabolic action, raising to restore, improve or modify physiological functions or specific medical diagnosis; "; Add to article 5.2 as follows: "52) pharmacovigilance: pharmacovigilance safety supervision;" Add to article 7.1 of the following paragraph: ' 71) import — import of medicinal products in the European Union customs territory from countries or territories which are not Member States of the European Union or the European economic area countries; "; Add to article 12.2 of the following paragraph: "122) adjuvants — ingredients of any medicinal product which is not the active substance or packaging material;" Add to article 16.1 of the point as follows: "161) falsified medicinal products, any drugs with fake identity (including the packaging and labelling), the name or composition for any component (including adjuvants and strength of exposure), the source (including the manufacturer, producer, country of origin and the owner of the registration) and history (including the production of records and documents relating to the use of the distribution network);"; Express 19.1 point as follows: "191) side effects caused by the use of the medicinal product: the organism is harmful and unintended reaction that; use". 2. in article 5: Supplement 1, after the word "unstoppable" with the word "renewable" and after the word "production" — with the words "or import"; Add to paragraph 6, after the words "as well as" with the word "veterinary"; Add to paragraph 22, after the word "requirements" with the words "the procedure for the assessment of qualifications"; to complement the article, 23, 24, 25 and 26 as follows: "23) the active substance import and distribution requirements and procedures, and importers of active substances, the manufacturer and the dealer registration procedures; 24) pharmacovigilance procedures; 25) analysis of access to medicines needed medicine wholesale sales and distribution; 26) pharmacies disseminated foods. " 3. Replace the words "in article 8 health economics Centre" with the words "national health service". 4. in article 10: (1) be expressed as follows: "1) organizes the collection of information about current events expertise for the quality of medicines, as well as drug consumption statistics in the country, through a pharmacy, herbal lieltirgotav, herbal medicinal products, the manufacturer, the importer, the medical institutions, practicing veterinarians and the veterinary care information provided by the authorities, and the collection and dissemination of information;" Add to article 1.1 and 1.2 of the point as follows: "11") provides information on the availability of medicinal products required for analysis of the medicinal product (with the exception of veterinary medicinal products) wholesale sales of medicines by the international non-proprietary name; 12) the public on its website the maximum prices of medicines in pharmacies; "; turn off paragraph 2, the words "for the observed medicine induced side effects"; Replace in paragraph 4, the word "control" with the word "expertise"; make paragraph 5 by the following: "5) ensure liaison with the institutions of the European Union, other countries ' competent authorities and international organisations medicines evaluation, registration, quality inspection, clinical research and pharmacovigilance, pharmaceutical licensing and compliance activities for the evaluation of medicinal products in the field of import, export, transit and distribution, registration of medical devices, clinical trials and the use of security surveillance, as well as human blood, tissues, cells and organs of the safety in use of the monitoring and evaluation of conformity;"; 7. turn the introductory part, the words "indicating the specific production and volume of the series"; make paragraph 7 b of subparagraph by the following: "(b)) if medication is required to treat a specific disease or therapeutic manipulation for specific medical or social care institution or specific animal disease treatment or manipulation, is not registered in the Republic of Latvia and the Latvian register of medicinal drugs in medical treatment because of the indication may not be used or their use is limited, based on the medical institutions or social care institution or a practicing veterinarian or veterinary care institutions written request, and If necessary, a doctor or veterinarian Professional Association of professional opinion, section "; Express 12. paragraph by the following: "12") evaluates the medicine lieltirgotav, manufacturer (foreign producer) and the importer shall verify the compliance officers of the qualifications and experience of compliance with regulations on the manufacture and distribution of medicinal products to the requirements and issue a special permit (license) for the activity, as well as the pharmaceutical special permission (license) the pharmaceutical activities, which as a special field of activity is the manufacture of veterinary medicinal products, import and distribution; " Add to article 12.1, 12.2 and 12.3 of the paragraph as follows: assessment and examination 121) "medicine producers and importers, including this law referred to in article 51.2 of the producers and importers of medicinal products, in compliance with the good manufacturing practice requirements and issue the certificate of good manufacturing practice; 122) evaluates and verifies the active substance manufacturer and importer compliance with the good manufacturing practice requirements and issue the certificate of good manufacturing practice; 123) evaluates and verifies and active substances of the medicinal product retailer compliance with good distribution practice requirements and provide good distribution practice; "; Add to article 17 and 18 with the following: "17) evaluate applications submitted to register the active substance manufacturers, importers and distributors, and record them on legislation, the active substance manufacturer importer and distributor logging in the order; 18) pharmacovigilance, including function of pharmacovigilance, create and maintain a database relating to the medicinal product safety oversight. " 5. Article 11 shall be expressed by the following: ' article 11. The national health service in matters within their competence, shall perform the following functions: 1) on State budget accounts payable medicine, medical equipment, medical technology and healthcare services economic evaluation; 2) developing guidelines in the field of health economics; 3) outpatient treatments eligible for medicinal products and medical devices and develop outpatient treatments and medicines for the eligible medical devices; 4) settlements with pharmacies for medicinal products issued and medical devices for the treatment of eligible hospital medicines and medical equipment purchase expense compensation procedures; 5) develop fixed medical institutions to use the medicine. " 6. in article 12, first paragraph: Add to paragraph 3, after the word "producer" with the word "importer"; make paragraph 9 by the following: "9) evaluates the veterinary pharmacies, veterinary medicinal products, the manufacturer of lieltirgotav (also foreign producers) and the importer shall verify the compliance officers qualifications and experience match the requirements of the law and issue a special permit (license) veterinārfarmaceitiskaj. This requirement does not apply to this law referred to in article 51.2 for manufacturers and importers of medicinal products; "; Add to part with the following paragraph 11: "11) evaluate a manufacturer of veterinary medicinal products and importer compliance with the good manufacturing practice requirements and issue of the veterinary medicinal product certificate of good manufacturing practice. This requirement does not apply to this law referred to in article 51.2 for manufacturers and importers of medicinal products. " 7. in article 14: Express (1) of the following: 1) for the purposes of supervision of pharmacy to monitor and control legal persons carrying out transactions with the products and the active substances, including pharmacies, medicine, medicine and lieltirgotav active substance manufacturers and importers, medical institutions, social care institutions, veterinary care authorities, customs warehouse where we store products and active substances and natural persons operating in the pharmaceutical field, regardless of their command , business lines and character, and to assess the distribution of the active substance compliance with legislative requirements, as well as their competence to give the persons referred to in this paragraph binding orders pharmaceutical issues; " supplement paragraph 5, after the word "producers" with the words "and importers '; make point 7 and 8 as follows: "7) prohibit any product as an active substance and Excipients, if it is established that they are of poor quality or counterfeit, but in the event of doubt about the quality of the medicinal product concerned, to suspend the active substance or an excipient for distribution to the final clearance for their quality; 8) prohibit the manufacture, import or distribution, remove and confiscate drugs if their manufacture, import or distribution is a violation of the laws and requirements in the field of Pharmacy; ". 8. Supplement article 22, third paragraph, after the word "medicine" with the words "and the" active substances. 9. Supplement article 25 by the word "production" with the word "import". 10. Express 25.2 article as follows: "article 25.2. The European Commission's recommendations (guidelines), published in the European Community pharmaceutical legislative framework document inventory (Eudralex), apply, preparing documentation on pharmacovigilance for medicinal products for human and veterinary medicine-related side effects and documentation relating to the active substance production, import and distribution, as well as pharmaceutical, clinical research, tracking, classification, labelling and instructions for use. " 11. the supplement to chapter III article 25.3 as follows: "article 15.7. Mediation deals with medicinal products for human use authorised, if the person is registered in the State Agency of medicines legislation on the distribution of medicinal products. " 12. Supplement article 31 with paragraph 10 by the following: ' 10) non-compliance with the regulations for pharmacovigilance requirements. " 13. Article 33 of the expression as follows: "article 33. Drugstore deals with the manufacture of medicinal products and medical treatment institutions of the recipes written requests to the treatment, health care or personal care product used for the storage, distribution and pharmaceutical care provision, as well as with the Cabinet of Ministers determine the distribution of foodstuffs. " 14. Add to article 40 paragraph 2 second subparagraph after the word "the" with the words "the pharmacist a pharmacist Assistant or veterinarian's Assistant". 15. Add to the first paragraph of article 56.1 to paragraph 3 by the following: "3) developed and approved a proficiency testing program for a person who qualifies for the certificate distribution of veterinary medicinal products, and to evaluate the qualifications of the applicant." 16. Supplement article 47 the second sentence after the word "producers" by the words "drug importers". 17. Supplement article 48 with the subparagraph 1.1 the following: "(11) lieltirgotav for medicinal products legislation duly allowed to supply veterinary medicinal products food and veterinary service of the veterinary statutory tasks." 18. Put the title of Chapter VII, the following: "Chapter VII and active substances of the medicinal products and the import and manufacture of the active substance distribution". 19. To supplement the law with article 50.1 the following: ' article 50.1. Drug importer is importing and distributing drugs and active substances. " 20. Article 51: Supplement to the second part of the article as follows: "(2) to produce, import, or distribute the active substances, it is necessary to ensure the requirements of the laws and appropriate facilities, equipment, staff and equipment, as well as the Cabinet's order to register its activities."; believe the current text of the first part of the article. 21. the express article 51.1 as follows: "article 51.1. Medicinal products and active substances and production controls followed the European Commission's Guide on good manufacturing practice principles and guidelines published. " 22. the express article 51.2 as follows: "article 51.2. Of medicinal products for human use, the manufacturer or importer authorized to manufacture or import a veterinary medicinal product if the special authorization (licence) for the production or import of medicines as a special permission (license) is in the manufacture of veterinary medicinal products or import them. The State Agency of medicines shall issued a special permit (license) shall inform the food and veterinary service, and that of producers and importers of medicinal products registered service of the object register. " 23. To supplement the law with article 51.3 of the following: ' article 51.3. To import medicines, you need to provide legislation on medicinal products or the manufacture of veterinary medicinal products and control appropriate facilities, equipment, staff and equipment and the law on the activities of the pharmaceutical or veterinārfarmaceitisk licensing in order to receive the special permission (license) of the medicinal product or the manufacture of veterinary medicinal products or import that as the scope specified in the import of medicines or importing of veterinary medicinal products. " 24. To supplement the law with article 52.1 the following: ' article 52.1. Medicine import company determines the import of medicines that officials responsible for the qualifications and professional experience in the manufacture of medicinal products meet the officers qualification and professional experience criteria laid down in the legislation on medicinal products and in the manufacture of veterinary medicinal products and control. " 25. the express 54. article as follows: "article 54. The manufacturer or importer of a medicinal product is permitted to distribute medicines produced drug manufacturers or importers, licensed medicine lieltirgotav, licensed pharmacies, medical authorities and veterinary authorities. " 26. To complement the article 56 of the word "producer" by the words "or importer". 27. Article 61 of the expression as follows: "article 61. (1) get a special permit (license) for the production or import of medicines has the right to legal persons is provided for the production or import of medicines necessary conditions and control features and which have specific legislation. (2) receive special permission (license) manufacture of veterinary medicinal products or import shall have the right to legal persons is provided for the production of veterinary medicines or to import necessary conditions and controls, as well as the participation of experts. The licence specifies the veterinary medicinal product or the forms that allowed to produce or to import. " 28. To supplement the law with article 61.1 of the following: ' article 61.1. (1) where a medicinal product and the active substance manufacturer's test results confirm compliance with good manufacturing practice, medicine State agency not later than 90 days after receiving the application, issue a certificate of good manufacturing practice. (2) if the drug lieltirgotav and drug manufacturer's test results confirm compliance with good distribution practice, medicine State agency not later than 90 days after receiving the application, issue a good distribution practice certificate. " 29. Add to article 62, after the word "producer" with the words "importer" of medicinal products. 30. Article 64: replace the words "health economics Centre" (the fold) with the words "national health service" (fold); Add to article 2.2 part as follows: "(22) the State Agency of medicines registration form and accompanying documents shall be reviewed and a decision on the test, or an active substance manufacturer, importer or distributor registration shall be taken no later than 60 days." 31. Supplement article 64.1 of the chapter IX with the following: "article 64.1. (1) the State Agency of medicines and food and veterinary service no later than 90 days from the date of receipt of the application, shall take a decision on the special permissions (licenses) of medicinal products or the manufacture of veterinary medicinal products or for import into or on the refusal to issue a license. (2) the State Agency of medicines and food and veterinary service not later than 30 days (in exceptional cases — not later than 90 days) from the date of receipt of the application, shall take a decision on the special permissions (licenses) of the medicinal product or the manufacture of veterinary medicinal products or import re-registering when you need to make changes to information: 1) than those produced or imported medicines, dosage forms, the place where they produce or control, as well as the qualified person; 2) on premises intended for the manufacture of medicinal products or import activities for technical equipment and control of manufacturing, quality control and storage process. 3) regarding the investigational medicinal product, or be produced investigational medicinal product to be imported types and forms, production and import operations and manufacturing processes (as in cases with a virus or a traditional agent decontamination), as well as the location where investigational medicinal products are manufactured on the premises of investigational medicinal products intended for the production or import activities for technical equipment and control facilities of the investigational medicinal product manufacturing, quality control and storage process and concerning the qualified person. (3) the State Agency of medicines and food and veterinary service no later than 90 days from the date of receipt of the application, shall take a decision on the special permissions (licenses) or veterinary medicinal products medicinal products to open lieltirgotav (operation) or on the refusal to issue a license. " 32. the transitional provisions be supplemented with 26 and 27 the following: "26 Cabinet until 31 January 2013 shall amend the Cabinet 4 October 2011 regulations No. 758" procedures for issuing, withdraw and extending the period of validity of the certificate distribution of veterinary medicinal products and register the certified person ", determining the order in which you perform the assessment of qualifications. 27. Article 10 of the Act 1.1 paragraph shall enter into force on July 1, 2013. " 33. To supplement the law with the informative reference to European Union directives as follows: "Informative reference to European Union directives, the law includes provisions resulting from: 1) of the European Parliament and of the Council of 6 November 2001 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products; 2) of the European Parliament and of the Council of 6 November 2001, Directive 2001/83/EC on the Community code relating to medicinal products for human use; 3) Commission of 8 April 2005 of Directive 2005/28/EC laying down the good clinical practice principles and detailed guidelines on investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products; 4) of the European Parliament and of the Council of 15 December 2010, the EU directive 2010/84/as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use; 5) of the European Parliament and of the Council of 8 June 2011-2011/62/EU directive, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards how to prevent counterfeit medicines from entering the legal supply chain. " The Parliament adopted the law in 2012 on November 29. The President a. Smith in Riga 2012 December 20.