Pharmaceutical Law Amendment

Original Language Title: Grozījumi Farmācijas likumā

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/221383

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) the amendments are as follows: 1. Article 1: Add to the article with a 12.1 point as follows: "121) practicing veterinarian, the person becomes entitled to practise veterinary practices and deals with it;"
Replace paragraph 18, the words "with" with the words "animal experiments with animals".
2. Make article 3 by the following: ' article 3. Concerning the supervision and control of the Republic of Latvia, the people in the field of medicinal products is the responsibility of the Ministry of health, but in the field of veterinary medicinal products: the Ministry of agriculture. "
3. To make article 4 second subparagraph by the following: "(2) a food and veterinary service monitors and controls for the production and distribution of veterinary medicinal products, as well as the use of medicinal products for human use of animals."
4. in article 5: turn off paragraph 16, the words "and it subsidiaries";
Express 18 as follows: "18) procedures for veterinary care institutions and practitioners veterinarians purchased, stored, recorded and used drugs;"
to supplement the article with 21 and 22 the following: "21) order in which German and collects information and creates statistics of movement of veterinary medicinal products;
22) person in distribution of veterinary medicinal products require professional qualifications requirements and procedures for issuing the certificate distribution of veterinary medicinal products, extend its validity period and it is cancelled, as well as the certified person registration procedures. "
5. To supplement the law with article 6.1 as follows: "article 6.1. Minister of agriculture within their competence, exercise of State policy in the field of veterinary medicinal products, medicinal products for animals organised within the framework of the laws drafting and enforcing the laws. "
6. in article 10: Add to the introductory paragraph, after the word "agency" with the words "within their competence";
make paragraph 1 by the following: "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, herbal manufacturer, medical institutions, practicing veterinarians and the veterinary care information provided by the authorities, and the collection and dissemination of information;"
Replace paragraph 7 of point "b", the words "certified" by the words "veterinarian practicing veterinarian";
7. turn the "d" section;
make the following point 12: ' 12) evaluate lieltirgotav and manufacturer of the medicinal product (also foreign producers) compliance with the examination of the 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 and distribution; ".
7. Make the article 12 by the following: ' article 12. (1) the food and veterinary service within their competence, shall perform the following functions: 1) assess, classify and record the veterinary medicinal product;
2) creates and updates the Latvian register of veterinary medicines, veterinary medicines granted registration numbers and codes, create and maintain a database of the observed adverse reactions to veterinary medicinal products, the dangers of the veterinary medicinal product, clinical trial and usage observation;
3) organizes the collection of information, collect information and statistics constitute the movement of veterinary medicinal products, with the manufacturer of the veterinary medicinal product, dealer, practicing veterinarians and the veterinary care authorities;
4) ensure quality control of veterinary medicinal products;
5) provide cooperation with other competent authorities for the assessment of the veterinary medicinal product, tracking and control;
6) issue of the veterinary medicinal product, as well as clinical trials of the veterinary medicinal product intended for import, export and distribution permissions, except veterinary in the illicit manufacture of narcotic drugs and psychotropic drug import, export and distribution of permits;
7) distribution of veterinary medicinal products shall be issued licences veterinary medicinal products which are not registered in the Republic of Latvia: a) the veterinary medicinal product is required for the specific treatment of the animal, the animal diseases for treatment or therapeutic manipulation and the Latvian register of veterinary medicinal products in the medical indication may not be used, based on the written request of a practicing veterinarian and, if necessary, the opinion of the Latvian society Veterinarian, b) veterinary medicinal products are required to provide veterinary assistance disaster , natural disasters or dangerous infectious animal diseases spreading in the case on the basis of the country's main veterinary and food Inspector's decision;
8) shall prepare and approve a list of bodies empowered to give an official opinion of the quality of veterinary medicinal products;
9) evaluates the veterinary pharmacies, lieltirgotav and veterinary medicinal products manufacturers (also foreign producers) compliance with the examination of officers qualifications and experience match the requirements of the law and issue a special permit (license) veterinārfarmaceitiskaj;
10) authorise the importation into the Republic of Latvia, diagnostikum in approval and new learning methods, implementation, and use.
(2) the Cabinet of Ministers shall lay down the food and veterinary service charges to the types of services and procedures performed for the actions provided for in this Act. "
8. Supplement article 14, paragraph 6, after the word "pharmaceutical" or "veterinārfarmaceitisk".
9. Replace article 17, first paragraph, the words "and the numbers 7 and 8" with numbers and the words "in paragraph 7 and 10".
10. Express article 20 (1) of the following: "1) drugs are prepared in a pharmacy in person or by the medical practitioner's prescription of a veterinarian, medical authorities or veterinary care institutions written request to a particular patient;".
11. To supplement the law with article 21.1 as follows: "article 21.1. If there is no available treatment and prevention of animals needing veterinary medicinal products, a practicing veterinarian at law duly authorized to distribute and use medicinal products for human use. "
12. in article 22: make the second paragraph as follows: "(2) where a medicinal product designated as prescription medicine, pharmacy, they may be issued only: 1) against the legislation, drawn up in the order of a physician or practicing veterinary prescription;
2) practicing veterinarian or veterinary care institution — against the practicing veterinarian written request. ";
to supplement the article with the fourth paragraph as follows: "(4) a practicing veterinarian and veterinary medicinal products comply with good principles of distribution."
13. Supplement article 25.1, after the word "agency" with the words "or, in the case of veterinary medicinal products-food and veterinary authority".
14. To supplement article 26, after the word "agency" with the words "or, in the case of a veterinary medicinal product: a food and veterinary service".
15. Article 29: Supplement to the second part of the article as follows: "(2) the evaluation of veterinary medicinal products, the registration, Reregistration and post-registration monitoring costs shall be borne by the applicant for registration in accordance with the laws on food and veterinary service of the national supervisory and control activities of paid service fee.";
believe the current text of article about the first part.
16. Add to article 30 of the "agency" with the words "and the food and veterinary service within the limits of its competence".
17. Article 34: make paragraph 3 by the following: "3) veterinary pharmacies.";
4. turn off the point.
18. Article 35: make the first part of paragraph 2 and 3 as follows: "2) make medicines by doctors or practicing veterinarian's prescription and medical authorities or veterinary care institutions written request;
3) provide medicines on prescription or medical veterinary prescription or practicing veterinarian written receipt of the request; "
to make a fifth by the following: "(5) the veterinary pharmacies: 1) distributes prescription and non-prescription veterinary medicinal products;
2) distributes the animal care and veterinary products intended for use in instruments and goods;
3) prescription of veterinary medicinal products shall be issued against the practicing veterinarian prescription prescription or on written request;
4) to produce the veterinary medicinal product is authorised only a pharmacist;
5) fast the veterinary medicinal products according to the technical requirements of the regulations. ";
turn off the sixth.
19. off 38. in the first paragraph, the words "or, in the case of veterinary pharmacy — the special permission (license) the distribution of veterinary medicinal products".

20. To supplement the law with article 38.1 the following: ' article 38.1. 33. This law, article 36 and 38 in the does not apply to veterinary pharmacies. "
21. Article 40 of the expression as follows: "article 40. (1) one of the pharmacies leader and deputy leader at the same time can not be pharmacies leader or deputy leader in the pharmacy or other responsible pharmacist or the pharmacist in charge, or the Deputy Head of the medicine lieltirgotav, or production manager or service control manager pharmaceutical company.
(2) the pharmacy distributed a veterinary medicinal product if: 1) the veterinarian or veterinārfeldšer, dealing with it, has received the Latvian society Veterinarian veterinary practices issued by the certificate or the distribution of veterinary medicinal products;
2) pharmacists, dealing with it, has received the Latvian society Veterinarian certificate issued in the distribution of veterinary medicinal products.
(3) If the master or open pharmacy distributes veterinary drug, then it is defined as the movement of veterinary medicinal products for which the officer is a graduate in human or veterinary pharmacy, and the special permission (license) to open a drugstore (performance) as a special field of activity is the distribution of veterinary medicinal products. The State Agency of medicines shall issued a special permit (license) shall inform the food and veterinary service, and that the pharmacy is registered service of the object registry.
(4) the veterinary pharmacy is laid down on the movement of veterinary medicinal products for which the officer is a graduate in human or veterinary pharmacy, and have received a special permit (license) to open a drugstore (operation).
(5) For the movement of veterinary medicinal products officer at the same time may not be on the movement of veterinary medicinal products officer at another pharmacy. "
22. To supplement the law with article 24.9 the following: ' article 24.9. (1) the Latvian society of veterinary surgeons perform the following administration tasks: 1) issued and revoke the re-registered at certificates distribution of veterinary medicinal products;
2) register the certificate requested distribution of veterinary medicinal products, and maintains a register of certified persons.
(2) the cabinet shall determine the fees for the certificate distribution of veterinary medicinal products and re-registering.
(3) the Latvian society, the official veterinarian shall perform the tasks referred to in the first paragraph: 1) is entitled to issue administrative acts;
2) is the functional authority Ministry of agriculture.
(4) the first paragraph of this article the tasks assumed by society of Latvia disputed the decision or appeal shall not suspend its activity. "
23. Replace article 45, the words "special permission (license) to open the medicinal lieltirgotav (performance)" with the words "special permission (license) medicine or veterinary medicine lieltirgotav lieltirgotav to open the (operation)".
24. To supplement the law with article 45 as follows: "article 45.1. Medicine for lieltirgotav, who received special permission (license) to open the medicinal lieltirgotav (performance), permitted to distribute veterinary medicinal product if the special authorization (licence) as a special field of activity is the distribution of veterinary medicinal products. The State Agency of medicines shall issued a special permit (license) shall inform the food and veterinary service, and this drug is registered service of the lieltirgotav object in the registry. "
25. Turn off article 48, first paragraph, the words "for practicing veterinārfeldšer.
26. To complement the article 51 after the word "production" by the words "or the manufacture of veterinary medicinal products".
27. Supplement article 51.2 law with the following: "article 51.2. The manufacturer of the medicinal product for human use authorised to produce veterinary medicinal products, where a special permit (license) for the manufacture of medicinal products as a special permission (license) is in the manufacture of veterinary medicinal products. The State Agency of medicines shall issued a special permit (license) shall inform the food and veterinary service, and that a drug company is registered service of the object register. "
28. Turn 59 the second part of the article.
29. Add to article 62, after the word "agency" with the words "food and veterinary service".
30. the transitional provisions be supplemented by the following paragraph 25: "25. The Person who distributes the veterinary medicinal product on pharmacies, which launched its activities by 2010 31 December is entitled to distribute veterinary medicinal product without a certificate distribution of veterinary medicinal products until July 1, 2012."
The law shall enter into force on January 1, 2011.
The law in the Parliament adopted the 2010 October 28.
President Valdis Zatlers in Riga of the 2010 November 17.