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. 13, no. 14; 2001) follows: 1. Replace the words "throughout the Act Welfare Minister" (fold) with the words "Minister of health" (fold), the words "National Veterinary Service" (folds) – with the words "food and veterinary service" (fold).
2. Replace article 3, point 8 article 10, paragraph 1, article 12, article 13, article 48, first paragraph, the words "Ministry of welfare" (fold) with the words "Ministry of health" (fold).
3. Express article 1 by the following: "article 1. The law is applied in the following terms: 1) medicinal products, medicinal products and medical devices;
2) non-prescription drugs — medicines that pharmacological properties, strength, quantity, packaging, use and possible side effects caused by the use of no direct or indirect threat to the health of the patient, if they are used according to the instructions. The pharmacy the outpatient treatment patients medication available without a prescription;
3) pharmacists practice in pharmaceutical operation whereby the pharmacist with pharmacy, individually or jointly, to provide pharmaceutical care furnished in accordance with the procedure prescribed by law and licensed pharmacies;
4) pharmaceutical care: a health care component, which their competence take the pharmacist, providing farmakoterapeitisk advice, information about drugs and their use. This care includes the supervision of Pharmacy continuing visitor use of medicinal products, medicines, and other health care, prevention and promotion products, manufacture of medicines, health promotion and disease prevention advocacy, on the basis of the latest scientific achievements and respecting the interests of visitors, as well as visitors to the data protection provision of their competence;
5) pharmaceutical and veterinārfarmaceitisk activities: pharmaceutical production, standardization, quality control and distribution, which is a type of business in the field of pharmacy, which requires a special permit (license);
6) pharmacy-drug research, development, production, standardization, quality control and dissemination;
7) homeopathic medicine: a product derived from the homeopathic stocks (products, substances or compounds) in accordance with a homeopathic manufacturing procedure for medicinal products, which is described in the European Pharmacopoeia or, if it is not described in the European Pharmacopoeia, pharmacopoeias, used officially in the Member States of the European Union. Homeopathic medicinal product may also contain a number of substances;
8 — medicinal products), storage, supply, movement across State boundaries (import, export), the sale or transfer for use in return for payment or free of charge;
9) quality: the efficacy of medicinal products which is dependent on raw materials and production methods and determined by assessing the safety, efficiency, cleanliness, the quantitative and qualitative composition, physical, chemical, biological and therapeutic properties and conformity with technical regulations or the documentation requirements of Pharmacopoeia;
10) quality control, pharmaceutical quality score verification (testing), determining their conformity with the technical documentation, regulations or requirements of Pharmacopoeia;
11) medication — medicine, prepared for a specific type of entering a specific form and distributed by the specific name given in the package;
12) from human blood and plasma-derived medicinal product: a medicinal product manufacture, including medicinal products based on blood constituents containing human protein (albumin), blood clotting factors, and promoting immunoglobulins (except blood, plasma or blood cells);
13) prescription medicines — medicines that pharmacological properties, strength, quantity, packaging, use and possible side effects of use without medical supervision can cause a direct or indirect threat to the patient's health. Pharmacy outpatient treatment of patients for the medicinal product in question only to the recipe;
14) veterinary medicinal products — medicinal products intended only for animal disease prevention, diagnosis or treatment;
15) veterinary product — healing, therapeutic AIDS premixtures, medicated animal care products and other products subject to the food and veterinary registration service;
16) substance: any matter irrespective of origin (of human origin, such as human blood or blood products; the human animal, such as micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts; chemical, such as chemical elements, naturally occurring chemical products or or synthesis for chemicals);
17) medications: any substance or combination of substances intended for human or animal disease treatment or prevention, as well as any substance or combination of substances which may be used for people or animals, to determine disease diagnosis or to restore, correct or modify human or animal physiological functions;
18) pharmaceutical clinical trials — with people (in the case of veterinary medicinal products on animals) studies, the purpose of which is to discover or verify the clinical, pharmacological medicines and other pharmacodynamic activity, identify their use side effects, pharmacokinetics, examine it to determine the use of the medicinal product safety and effectiveness;
19) instructions for use of medicinal products (hereinafter referred to as the manual): information for the user which accompanies the medicinal product;
20) pharmacovigilance observations — the Republic of Latvia registered medicine documentation of observations that do not affect the planning and conduct of their use;
21) — manufacture of materials and products, manufacturing process, quality control, release and distribution activities and the associated controls. "
4. To exclude article 2, the words "and" pharmaceutical products ".
5. Article 5: make (2) of the following:

2) and by the recommendations of the Ministry of health confirms the quality of the medicinal product in the list of control authorities which shall be entitled to give a formal opinion on the drug, including from human blood and plasma-derived medicinal product and homeopathic medicinal products, quality control results; "
turn 4 and paragraph 6, the words "and" pharmaceutical products ";
make point 7 by the following: ' 7) procedures for the treatment and social care institutions purchased, stored and used drugs; "
Add to article 17 and 18 with the following: "17) and the pharmacist a pharmacist Assistant registration procedures;
18) procedures for veterinary care institutions and persons engaged in veterinary practice, acquired, stored and used in veterinary medicine. "
6. Article 6: Express point 2 as follows: "2) determines the order in which measurable and medicines to be registered, and the order in which you are registered in the Republic of Latvia, the list of medicinal products (hereinafter referred to as the Latvian register of medicinal products), as well as certified pharmacists and licensed pharmacies, drug lieltirgotav and pharmaceutical company register;";
turn off paragraph 7, the words "and" pharmaceutical products ".
7. in article 9: replace the first paragraph, the words "for State and local government capital companies" with the words "for State and local government owned capital shares and enterprises";
Add to the first paragraph after the words "On limited liability companies" with the words "and regulations";
to turn off the second sentence of the second subparagraph;
turn off third.
8. Article 10: Express 1 and 2 in the following wording: "1) organizes the collection of information on the latest developments in drug quality control, as well as drug consumption statistics in the country, through a pharmacy, herbal lieltirgotav, pharmaceutical company, medical institutions, veterinary care information provided by the authorities, and the collection and dissemination of information;
2) created and regularly updated register of medicinal products of Latvia assigned registration numbers and codes for medicinal products, create and maintain a database of medicine causes the observed adverse reactions for medicinal consumption statistics, as well as clinical trials of medicinal products and pharmacovigilance observations; "
excluded in paragraph 3, the words "and subject to the registration of pharmaceutical products";
turn 4 and paragraph 8, the words "and" pharmaceutical products ";
make paragraph 5 by the following: "5) organizes cooperation with other competent authorities of the country of medicines, registration and control;"
make the following paragraph 11: "11) valued medicine clinical trial compliance with good clinical practice requirements;";
to supplement the article with paragraphs 12 and 13 of the following: "12") laws in the order issued by special permission (license) the pharmaceutical activity, recognize other competent national authorities issued special permits (licences) and the pharmaceutical company conformity assessment activities;
13) down herbal affiliation at the OTC or prescription drugs Cabinet. "
9. To make article 14 the following: ' article 14. National pharmaceutical inspection officials, but the movement of veterinary medicinal products in food and veterinary service of the inspectors within the framework of its competence has the right to: 1) for the purposes of supervision of pharmacy to monitor and control legal persons carrying out transactions with medicines, pharmacies, medicinal products, also lieltirgotav, pharmaceutical companies, medical institutions, social care institutions, veterinary care authorities, customs warehouses, which are stored in the halls, and the persons that operate in the field of pharmacy, regardless of their command , business lines and character, to assess compliance with the distribution of legislative requirements, as well as their competence to give the persons referred to in this paragraph binding orders pharmaceutical issues;
2) make space, equipment, personnel and documentation assessment according to the work to be carried out and its quantity;
3) control of compliance with the outpatient medicinal products for the treatment and the purchase of medical equipment for the refund;
4) cooperation with international organizations and other concerned institutions;
5) do mystery shopping and doubt or suspicion, taken from pharmaceutical companies drug activity samples and send them to quality control the quality control of medicinal products. Pharmaceutical quality control samples shall be borne by the pharmaceutical company, the action if the product does not meet the technical provisions or of the documentation requirements of the Pharmacopoeia, but if the product meets these requirements, expenses are covered from the national pharmaceutical inspection and food resources of the veterinary service;
6) in accordance with the laws and regulations to stop the legal or natural persons or to suspend the operation of the pharmaceutical product distribution to final clarification of circumstances;
7) prohibit any distribution of medicinal products, if it is established that they are of poor quality, but in case of doubt about the quality of the product, stop their distribution to final quality. The decision in this case accepted not later than 60 days from the date of the finding of the infringement;
8) prohibit the manufacture or distribution of medicines, and seize the drugs if their production or distribution is made in violation of the laws and requirements in the field of Pharmacy;
9) to propose to the pharmaceutical activities of infringement is suspended or withdrawn special permit (license) for the activity in the pharmaceutical or permit the purchase of medicinal products;
10) to monitor the advertising of medicinal products;
11) to punish the perpetrators of violations of the laws. "
10. Express article 15 the following: ' article 15. National pharmaceutical inspection resources form the national grant from the general revenue and general revenue from the fees. Paid service types and their procedure determined by the Cabinet of Ministers. "
11. Express article 17 as follows: "article 17. (1) authorized to distribute only the Republic of Latvia and the Latvian registered in the register of medicinal products or the Latvian register of veterinary medicinal product included in this law, except article 10, paragraph 7 of article 12, paragraph 7 and 8 and referred to in article 20.
(2) the European Agency for the evaluation of medicinal products the centralised procedure established in the registration Hall may be distributed without this registration. "
12. Turn off the article 19, the words "and" pharmaceutical products ".
13. in article 20:

replace the introductory phrase, the words "medicinal" with the word "substance";
Replace in paragraph 3, the words "medicinal" with the words "intended" substance.
14. Turn off article 21, the words "and" pharmaceutical products "and the words" and "pharmaceutical products.
15. in article 22: turn off in the first paragraph, the word "ready";
to complement the second paragraph after the word "doctor" with the words "or veterinarian";
to supplement the article with the third part as follows: "(3) as a wholesaler in medicinal products provide good distribution of medicines in the principles and guidelines by the European Commission published instructions, and in accordance with European Union law."
16. To supplement the law with article 25.1 the following: ' article 15.6. (1) the Member State of the European Union or European economic area country a registered company that has been issued in the country of a special permit (license) for the manufacture of medicinal products or wholesale trade, may open a branch (Representative Office), and the launch of the wholesale of medicines of the Republic of Latvia only after the company's country of residence issued by the special permission (license) is recognized in the Republic of Latvia Cabinet of Ministers. In this case, a company is not required to get this law, in article 25 of the special permission (license).
(2) foreign companies are obliged to notify the Agency of the branch (Representative Office) opening in the Republic of Latvia Cabinet of Ministers.
(3) in the Republic of Latvia registered businesses making pharmaceutical operation, is obliged to notify the Agency of the branches (representative offices) of foreign open Cabinet. "
17. off 26.1 article, the words "and" pharmaceutical products ".
18. off article 28, the words "or pharmaceutical products".
19. To supplement the law with article 28.1, of the following: ' article 28.1. The documents accompanying the request for registration shall be submitted in accordance with the Cabinet's requirements for the registration of medicinal products and taking into account the recommendations of the European Commission for the documentation and requirements on quality, safety and effectiveness. "
20. Article 31 of the expression by the following: ' article 31. Registration is suspended or withdrawn if: 1) product, they use, according to the information in the registration dossier (for instructions, and other documentation of the technical regulations), are destructive;
2) medicinal products have no therapeutic effect;
3) its qualitative and quantitative composition is not a registration dossier;
4) submitted false information or registration information is not complete, or not drug control components according to the information in the registration dossier;
5) medicine labelling or the package leaflet do not comply with the legislation on the labelling of medicinal products;
6) is a judgment of the Court of Justice for infringement of intellectual property rights;
7) registration documentation not in conformity with the requirements of Community legislation;
8) registration applicant has submitted an application to revoke or suspend the registration of the medicinal product;
9) is not made in article 29 of this law with the required registration-related payments. "
21. Article 33 of the expression as follows: "article 33. Pharmacy is a company or stationary hospital's Department dealing with the manufacture of medicinal products and medical treatment institutions of the recipes written requests, with the production of medicines, medicinal products, as well as health care or personal care product used for the storage, distribution and the provision of pharmaceutical care. "
22. Supplement article 35 the fifth subparagraph after the word "including" with the word "veterinary".
23. Article 38 be expressed as follows: "article 38. (1) pharmacies run by and for its responsible pharmacies leader who received the pharmacist professional qualification certificate or, in the case of veterinary pharmacy — the special permission (license) the distribution of veterinary medicinal products.
(2) the pharmacist and a pharmacist's Assistant, who works at the Pharmacy: 1) registered Pharmacists Association of Latvia Cabinet of Ministers in the order and respect the Pharmacist society of Latvia approved the code of ethics;
2) professional qualifications, with the participation of the Latvian Association of Pharmacists, the recognised continuing education process.
(3) a pharmacist and a pharmacist's Assistant, who received his education in the country, which is not a Member State of the European Union and European economic area countries, and not in the European Union or European economic area national citizenship, and which is recognised diplomas in the laws in order to start your own practice pharmacy, at least one year must work on pharmacy pharmacist supervision. "
24. Article 39 be expressed by the following: ' article 39. Cities and other populated areas where the population does not exceed 4000, up to 30 June 2004 for pharmacy managers can be a pharmacist's Assistant, who has at least five years ' seniority in the specialty and who received the authorization of the Ministry of health, but from July 1, 2004 for pharmacy managers can be the Latvian Association of Pharmacists registered pharmacist Assistant with at least five years ' seniority in the management of Pharmacy When his pharmacist practice is interrupted for more than five years from the date on which the certification authority filed an application for a certificate of professional qualification pharmacist. "
25. Turn off article 42, the words "in coordination with the Ministry of Welfare".
26. Turn off article 43, the words "pharmaceutical products".
27. To supplement the law with article 46.1 the following: "article 46.1. (1) the medicine lieltirgotav on good distribution practice compliance is determined responsible officer: 1) which has the highest pharmaceutical education or satisfying the Health Minister approved the qualification and experience requirements;
2) which is not suffering from mental illness, drug addiction or alcoholism, toksikomānij;
3) which has a perfect reputation that is recognised, if: (a) the person is not convicted) for committing a criminal offence, (b) that person is not) the Court has declared bankrupt the debtor, c) this person repeatedly during the year is not administratively punished for violations of the pharmaceutical activities;
4) which does not simultaneously occupy the same positions in other lieltirgotav as well as medicinal products is not a pharmacy. "
28. Make the article 50 as follows: "article 50. Pharmaceutical company is a company that manufactures and distributes drugs and substances. "
29. To supplement the law with article 51.1 of the following:

"51.1 article. Pharmaceutical and medicine manufacturing controls followed the European Commission's Guide on good manufacturing practice principles and guidelines published. "
30. the express 54. article as follows: "article 52. Pharmaceutical company for the production of medicinal products is determined that officer qualifications and vocational experience sliding down the requirements, the Cabinet of Ministers. "
31. Article 58 of the following expressions: "article 58. (1) a pharmacist certificate of professional qualification are entitled to: 1) to the person who obtained the highest pharmaceutical education in the Republic of Latvia or abroad and obtained education and duration of professional experience recognised in law. Recognition of professional experience is required to: (a) the pharmacist pharmacy) in the Republic of Latvia, a Member State of the European Union or European economic area country had worked continuously for three years. The obtained abroad stating relevant professional experience in a certificate or other document issued by the competent national professional organization, (b) pharmacists practice in pharmacies) would not be interrupted for more than five years from the date of certification application submitted to the institution of the pharmacist's professional qualification certificate;
2) which is not suffering from mental illness, drug addiction or alcoholism, toksikomānij;
3) which has a perfect reputation that is recognised, if: (a) the person is not convicted) for committing a criminal offence, (b) that person is not) the Court has declared bankrupt the debtor, c) this person repeatedly during the year is not administratively punished for pharmaceutical operations.
(2) the Latvian society of Pharmacists and pharmacists and pharmacist assistants maintain and certify their professional experience. "
32. To supplement the law with article 60.1 of the following: ' article 60.1. Special permission (license) to open the medicinal lieltirgotav (operation) can receive legal persons, if their main business is the distribution of medicinal products and medicinal products for good distribution practices of responsible executive complies with this law, the requirements set out in article 46.1. "
33. Article 62 be expressed by the following: ' article 62. Pharmacy, medicine, lieltirgotav pharmaceutical company, medical establishment, social care and veterinary care authority shall provide to the Ministry of Health, the Agency, the country's pharmaceutical authorities, the Latvian Association of pharmacists in the information about your medicine and pharmaceuticals, you need this law and other laws and regulations on the distribution and control of the specific feature of execution. "
34. transitional provisions be supplemented with 15-21 as follows: "15. Minister of health until the national agencies ' national medicines agency" is to create a national shareholders ' representative agency.
16. The Cabinet of Ministers until January 1, 2004 to issue regulations governing this Act article 5, paragraph 17, a pharmacist and a pharmacist Assistant registration procedures.
17. Article 17 of this law the second part, article 22, third paragraph, article 25.1, article 31, article 38 of part three, article 60.1 46.1 and entry into force is determined by a special law.
18. This law article 46 and 60 power loss is determined by a special law.
19. Up to 31 January 2003, the Ministry of welfare issued a pharmacy management authorization is effective until the end of this period.
20. A pharmacist Assistant who received permission issued by the Ministry of health for pharmacy management, but do not comply with the requirements in accordance with article 39 of this law, the head of the pharmacy are from July 1, 2004, can be controlled to permit pharmacies to the expiry of the said period.
21. Article 39 of this law shall be in force until 31 December 2010. "
Transitional provisions with the entry into force of this Act shall terminate the constitutional order of article 81 of Cabinet of Ministers issued Regulation No. 3 "amendments to the pharmaceutical law" (Latvian journal, 2003, no. 4).
The law adopted by the Parliament in 2003 on April 16.
State v. President Vaira Vīķe-Freiberga in Riga on May 7, 2003 Editorial Note: the law shall enter into force on the 21 May 2003.