Cabinet of Ministers Regulations No. 540 in Riga august 13, 2013 (pr. No 44 133) amendments to the Cabinet of Ministers of 26 June 2007 No. 436 "provisions of the import and export of medicinal products order Issued in accordance with article 5 of the law of Pharmacy (3) and the law" on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order "article 28 do cabinet 26 June 2007 No. 436" provisions of the import and export of medicinal products order (Latvian journal, 2007, 104 no; 2008, 92 no; 2009 , 157. no; 2010, 148 no). the following amendments: 1. Replace the text, the words "registration certificate holder (owner)" (fold) with the words "registration holder" (fold). 2. Add to subparagraph 9.1 behind the words "strength" or "concentration". 3. Add to chapter III, with 32.1 point as follows: "32.1 expenses associated with issuing a permit for the import of samples of medicinal products shall be borne by the applicant in accordance with the State Agency of medicines to the public provided by the paid service price list. The State Agency of medicines allows pharmaceutical imports or a duplicate sample permissions issue to the applicant an electronic document in the form of three working days after the decision, sending it to the application specified in the electronic mail address. Paper document in the form of a permit or a duplicate shall be issued within three working days of the request for additional fees in accordance with the State Agency of medicines provided by the public service pay list price. " 4. Replace the words "in paragraph 21.9. the holder of the registration certificate (the owner, if they are different people)" with the words "registration of the owner, if they are different individuals." 5. Add to 36.1. subparagraph after the word "address" with the words "as well as the contact information (phone, fax and e-mail address). 6. Delete word in 36.6 "product". 7. Make the following subparagraphs 36.12.: 36.12. If the registration is not the owner of the pharmaceutical form of medicinal products, the manufacturer shall indicate the form of the business name and address of the manufacturer and shall be accompanied by a document certifying that registration the owner agrees to share the information. " 8. Supplement 37.1 37.1. subparagraph 1., and after the word "address" with the words "as well as the contact information (phone, fax and e-mail address). 9. Add to paragraph 38 with the third and fourth sentence as follows: "the State Agency of medicines of the certificate and notice of the registration status of the product shall be issued in the form of an electronic document, by sending them to the application specified in the electronic mail address. Paper document in the form of a certificate and a notice or a duplicate shall be issued within three working days of the request for additional fees in accordance with the State Agency of medicines provided by the public service pay list price. " 10. To supplement the provisions and paragraph 23.8 23.7 as follows: "the State Agency of medicines of 38.2 short certificate is issued in the form of an electronic document, by sending them to the application specified in the electronic mail address. Paper document in the form of a certificate and a notice or a duplicate shall be issued within three working days of the request for additional fees in accordance with the State Agency of medicines to the public provided by the paid service price list. the application of this provision 23.8 35.1. products referred to in the certificate, that rule 35.2 of the notification referred to in paragraph about the registration status of the product and the rules referred to in paragraph 21.8 short certificate is issued, you can submit an electronic document in the form of preparing them according to the law on electronic document design. " 11. To supplement the provisions of this paragraph 25.8: "25.8. If you suspect a possible counterfeit medicinal products." 12. Supplement with 53.1 and 53.2 Chapter V paragraph by the following: "health inspection, 53.1 medicine State Agency and the food and veterinary service cooperate within their competence in order to ensure that the products imported and which are not intended to be placed on the European Union market, not getting into movement, if there is reasonable suspicion that they are counterfeit. 53.2 customs authorities shall immediately report to the health authorities and the National Agency for medicines, if there is suspicion of possible counterfeit medicinal products. " 13. To supplement the rules with 56.1 points as follows: "the claim that 56.1 subject to this rule 32.1, 38, 38.2 and 38.3 points of service referred to in paper form for the fee, applicable by 2014 July 1." 14. Add to the informative reference to European Union directive in paragraph 6 by the following: ' 6) 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. " 15. To supplement annex 1 with 3. Note the following: "3. the document property" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." 16. To supplement the annex with the following note 4: "4. the document property" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." 17. To supplement the annex to this note 14:14) "document properties" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." 18. To supplement annex 5 with the following note 3:3) "document properties" signature "does not fill in, if an electronic document is drawn up according to the law on electronic document design." Prime Minister Valdis Dombrovskis Health Minister Ingrida Cricket»