Amendments To The Cabinet Of Ministers May 9 2006, Regulations No. 376 "the Procedure Of Registration Of Medicinal Products"

Original Language Title: Grozījumi Ministru kabineta 2006.gada 9.maija noteikumos Nr.376 "Zāļu reģistrēšanas kārtība"

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Cabinet of Ministers Regulations No. 602 in Riga in 2008 (28 July. No 53 35) amendments to the Cabinet of Ministers may 9 2006, regulations No. 376 "registration procedure for medicinal products" Issued in accordance with article 5 of the law of Pharmacy (3) to make the Cabinet may 9 2006, regulations No. 376 "registration procedure for medicinal products" (Latvian journal, 2006, 97 no; 2007, 137 no) the following amendments: 1. Make the following paragraph 17.16:17.16. "the document which certifies the right of producers to manufacture the medicinal product concerned country the report, issued by the European economic area, the competent authority of the Member State that has inspicējus in the place of production, or good manufacturing practice certificate (no older than three years), issued by a European economic area country competent authority which is inspicējus production. That document can replace the reference to good manufacturing practice requirements or the summary of the good manufacturing practice inspections carried out during the last two years; ".
2. Make the following paragraph 28.3: "28.3. standards that are used in the testing of the finished product (hereinafter referred to as the reference (reference) standards), and materials;".
3. Make the following paragraph in 86.3:86.3. entitled "expose the medicinal product, its raw materials and intermediate products or other constituent materials for testing by the national agency of medicinal products in a laboratory or another laboratory (laboratory according to the good manufacturing practice requirements of the European Commission's guidelines on medicinal products and investigational medicinal products good manufacturing practices, is the right to control drug), to ensure that the manufacturer of the control methods used, which in accordance with the provisions of paragraph 11.1. below are described in the documents supporting the application for registration (paragraph 17) is satisfactory; ".
4. Delete the second sentence of paragraph 87.2.
5. Replace the words in subparagraph 122.5. "national pharmaceutical inspection '' with the words ' health inspection '.
6. Replace paragraph 126, the words "the State Pharmaceutical inspection '' with the words ' health inspection '.
7. To express 3.21.6. subparagraph by the following: ' 21.6. (reference) reference standards or materials; ".
8. Express 3.37.2. the third sentence as follows: "provide information that demonstrates that the materials comply with the reference (reference) standards. ''
9. Express 3.40 as follows: "40. Defines and describes in detail at called (reference) preparations and at sa (reference) ces standards. If necessary, use the European Pharmacopoeia chemical and biological reference material. ''
10. To express 3.48 the following: "48. Defines and describes in detail the preparations of reference and reference (reference) standards used for testing of the finished medicinal product, if this information is provided in the section on active substance. ''
11. Express bottom point as follows: " audit certificate (s), if any (-i) is issued by the European economic area Member State, the competent institution which shall carry out the audit; ''.
12. Express subparagraph as follows: "66.4.2. audit certificate (s), if any (-i) is issued by the European economic area Member State, the competent institution which shall carry out the audit;".
13. Express 3.69.3. the introductory subparagraph by the following: "69.3. with regard to pharmacokinetic studies of kokinētik of population analysis of farm based on a selection of rare, and clinical trials may include questions about how internal and external factors influencing the kinetics of dose and farmak. Provides: "14. Express of annex 5, paragraph follows 13.1.17.:" 13.1.17. If needed, provide information about the herbal substance (s) and herbal preparation (s) used in the testing (reference) reference standards or materials; ".
15. Replace the words "Annex 8 new non-standard technique or a standard technique used in a novel way" with the words "unapproved techniques or techniques used in a new way".
16. Make 8. point 8 of the annex to section "conditions" of paragraph 4 by the following: "4. Have successfully completed the testing methods of transfer from the old to the new site or new pharmaceutical quality control lab."
17. Annex 8. Delete paragraph 33 section "conditions" in paragraph 4, the word "standard".
18. Make 8.43 the following: "43.
Measuring or administration device that is not directly an integral part, add, replace, or off (except for metered dose inhaler spacer dose) 43.1. medicinal products for human use 43.1.1. Add or replace conditions: 1, 2 (see below) I A 43.1.2. exclusion condition: 3. I B conditions: 1. The proposed means of measuring precisely measured dose needed for the product concerned in accordance with the approved dosage of the medicinal product, and the results of such studies should be available.
2. The new device is compatible with the medicinal product.
3. Medicinal products can still be precise measurements. ''

Prime Minister i. Godmanis Health Minister, the Minister of Interior Mr Segliņš Editorial Note: rules shall enter into force on the 1 august 2008.

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