Cabinet of Ministers Regulations No. 83 in 2016 (2 February. No 5 27) amendments to the Cabinet of Ministers of 17 January 2006 no. 57 "provisions of the rules on the labelling of medicinal products and pharmacovigilance requirements" for izvirzāmaj instructions Issued in accordance with article 5 of the law on Pharmacy 3 and 12 point 1. make Cabinet of 17 January 2006 no. 57 "provisions of the rules on the labelling of medicinal products and pharmacovigilance requirements" for instructions izvirzāmaj (Latvian journal, 2006, No 14; 2008 53., no; 13.149.80, no.) the following amendments: 1. Express 4, 5 and 6 of paragraph by the following: "4. the instructions for use shall be included in (or attached insert) all medicine containers, unless all the information referred to in paragraph 7.3 of these provisions, 14, and 15, paragraph 14.1, conveyed on the secondary or primary packaging. 5. If a medicinal product imported in Latvia, information on the label and in the instructions for use of the national language is not specified, then the distribution of medicinal products, the packaging of medicinal products attached label with the information provided on the label in the national language, and the translation of the instructions for use of the national language in the secondary packaging or attached to the medicine secondary or primary packaging (does not apply to products, which distributes wholesale to its export to third countries or for supply to another European economic area Member State). If the secondary package is sealed in such a way that it cannot be opened without damaging the packaging (for example, sealed), the instructions State language attached to the outside of the packaging. These labels and instructions for use on the packaging or in the secondary packaging insert considered repackaging of medicines, by persons in accordance with the laws and regulations on pharmaceutical licensing activities is the State Agency of medicines issued a special permit (license) for the production of medicinal products. 6. in paragraph 5 of these rules, the above requirements shall not apply to: 6.1. individual patients not registered medicinal products provided that, in accordance with the laws and regulations on the distribution and quality control procedures are imported on the basis of the State Agency of medicines authorisation does not register the distribution of medicinal products medicinal products granted individually and through its pharmacy, has been added to at least the following information: 6.1.1. State the name of the medicinal product; 6.1.2. the name of the active substance and Excipients, and quantity; 6.1.3. the pharmaceutical form and content; 6.1.4. instructions for use and route of administration; 6.1.5. specific warnings about the storage of the medicinal product for children invisible and inaccessible location and other specific warnings (if specified); 6.1.6. the period of validity; 6.1.7. storage conditions (if specified); 6.1.8. serial number; 6.1.9. Special precautions for disposal of unused medicinal product or waste materials, which have been in contact with the medicinal product (if specified); 6.1.10. the registration certificate the name and address of the owner, the medicine name and address of the manufacturer; 6.1.11. possible side effects (if specified); 6.2. the supply of medicinal products for human therapeutic body if a specific consignment of medicines for at least one of the medicinal products concerned, labelling and package leaflet a translation in the language of the country. Pharmaceutical supplier according to the hospital's request provides the necessary number of translations of the marking and instructions for use of the national language. "; 1.2. to supplement the point behind the figures 7.1 and the words "as defined in paragraph 7.11." with the following sentence: "the information on the labelling of medicinal products and in the instructions for use, in addition to the national language can be specified in another foreign language, which differs from medicine in Latvia registered the label and in the instructions for use of a foreign language;" 1.3. to replace the words "in paragraph 7.4 above the label data can be in multiple languages" with the words "the information on the label, the label also, in addition to the national language can be specified in several foreign languages"; 1.4. Express 7.6. subparagraph by the following: "7.6. State Agency of medicines has the right to adopt specific measures and release the registration of owners and wholesalers of medicinal products from the obligation on the labelling of medicinal products authorised in the instructions for use and specific data as referred to in the registration dossier, labelling and instructions for use, as well as fully or partly released from the obligation to provide the medicine label and instructions for use of the national language, if the product is not intended to be delivered directly to the patient, or if there is an emergency situation in relation to the significant difficulties in access to medicines and essential risk public health or life (does not apply to this rule 9.1); "; 1.5. deletion of 7.9 in the word "primary"; 1.6. to make the introductory part of point 7.11 by the following: "parallel imported 7.11. If the label on the packaging of the medicinal product are specified therapeutic indications approved by the other Member States, but which are not approved by the Republic of Latvia register of medicinal products medicinal products included in this information is covered with a sticker. Parallel imported medicinal products, labelling and instructions for use by content corresponds to the Republic of Latvia register of medicinal products medicinal products included in the marking and instructions for use, in relation to which the parallel imports carried out (hereinafter referred to as the reference medicinal product), allowing such differences in the labelling and instructions for use: "; 1.7. to supplement the provisions under 7.1 points as follows: "the parallel imported medicinal products 7.1 labels on the secondary containers or, failing that, on the primary packaging contains the following information: 1. the" parallel imported 7.1 medicine "; 2. Medicinal products 7.1 public agencies in parallel imported medicinal product granted a distribution permit number; 7.1 3. parallel imported medicinal product distribution the holder (owner's) name and address; 7.1 4. where medicinal products are repacked, − the repackaging of the serial number as well as the manufacturer of the medicinal product (pārpakotāj) name and address, if the parallel imported medicinal products distribution the holder (owner) is the medicine pārpakotāj; 7.1 5. differences from the Republic of Latvia the Latvian register of medicinal products in relation to which made parallel imports, if any. "; 1.8. to supplement the provisions under point 9.1 and 9.2 as follows: 9.1 "medicinal products distributed by medical authorities fixed, each secondary packaging in addition to the marked (stamp or other marking) with the national language" packaging "for the hospital. It is easily readable, clear, or not removable. If the packaging is not annotated, before distribution to provide medicine or pharmacy that lieltirgotav drugs for treatment of hospital supplies. 9.2 these terms 12 and 16 above may not apply to medicinal products as referred to in point 6.1 of these regulations, and which distributes wholesale to its export to third countries or for supply to another European economic area Member State. "; 1.9. the deletion of the words in paragraph 10.15.: "a parallel imported medicinal product shall also in parallel imported medicinal product distribution the holder (owner's) name and address."; 1.10. to express the following paragraph 13: "13. Registration holder shall ensure that the information in the instructions for use, in accordance with the description of the medicinal product. '; 1.11. the deletion of paragraph 27, the words "secondary"; 1.12. the deletion of the second sentence of paragraph 29; 1.13. replace paragraph 30, the words "the State Agency of medicines shall submit application" with the words "the owner of the marketing of medicinal products in the National Agency shall submit application to the"; 1.14. the deletion of the second sentence of paragraph 31; 1.15. paragraph 32 be expressed as follows: "32. Expenses related to the drug label and instructions for use check the translations are included in the registration fee, or pay for a parallel imported medicinal product distribution licence or application and documentation expertise pay a European economic area country, but registered in the Republic of Latvia does not register the distribution authorization, as determined by the laws of the State Agency of medicines paid service price list."; 1.16. supplement with 39 points by the following: "39. This rule 9.1 of the type referred to in paragraph 1 to be introduced on May 1 2016." 2. the rules shall enter into force on March 1, 2016. The Prime Minister is the Rapidity of the Newsletters Health Minister Guntis Belēvič in