Cabinet of Ministers Regulations No. 641 in Riga august 4 2008 (pr. No 55 46) amendments to the Cabinet of Ministers of 18 April 2006, regulations No 304 "rules for the production and control of medicinal products order about pharmaceutical officers qualification requirements and professional experience and the order in which pharmaceutical company to issue the certificate of good manufacturing practice ' Issued in accordance with article 5 of the law on Pharmacy 3 and 13 and article 52 to make Cabinet of 18 April 2006, regulations No 304" rules for the production and control of medicinal products order for pharmaceutical officers qualification requirements and professional experience and the order in which pharmaceutical company to issue the certificate of good manufacturing practice "(Latvian journal, 2006, 70 no; 2007, nr. 33) the following amendments: 1. Replace the text, the words" the State Pharmaceutical inspection "(fold) with the words" health inspection "(fold).
2. Replace paragraph 4.6., second sentence, the words "qualification stage" with the words "qualifying period".
3. Delete paragraph 8.4., the words "24-hour".
4. Replace paragraph 14, the word "objects" with the words "study courses".
5. Express 31 the following: "31. producer of medicines manufactured from human blood and plasma-derived medicinal product: 31.1. provides this in the manufacture of medicinal products used in the manufacturing process and the whole cleaning process according to the validation to ensure all the homogeneity of the series and guarantee safety against infection with specific viruses (hepatitis B surface antigen (HBS Ag), HIV 1 and HIV 2 antibodies (anti-HIV ½), hepatitis C virus antibodies (anti-HCV));
31.2. inform the State Agency of medicines of the methods that is used to know sam or eliminate pathogenic viruses that can be transmitted through such medicinal products;
31.3. the medicinal product used in the production of raw materials (human blood and plasma) that are received from the blood to the authorities in the preparation of human blood and blood components collection, testing, processing, storage and distribution takes place according to the laws of human blood and blood components collected horse, testing, processing, storage and distribution of the quality and safety standards and subject to the health statistics and medical technologies State Agency control. Human blood and human plasma, intended from human blood and plasma derived production, mining the site exposed to the drug control agency of the country. "
6. To express the following paragraph 20.1 "20.1. is entitled to take raw material testing, based on the application of the same manufacturer, if the manufacturer is established in the Republic of Latvia."
7. Express section 71.1. the following wording: "71.1. purified water obtained from the pharmacy. Analysis is conducted once a day before preparation of the medicinal product, taking water from each container, or, if you use the pipeline, each place of examination of calcium and magnesium, and the presence of hlorīdjon sulfātjon according to the requirements of the European Pharmacopoeia. The solution provided for newborns and eye drop preparation for water reducētājviel and also check for the presence of ammonium ions. Purified water every six months in a pharmacy sends the State Agency of medicines of the full chemical analysis; ".
8. Express 82 as follows: "After this rule 82.81. Medicinal products referred to in the control of the national agency of health inspection report, shall take a decision on the suspension of the production of medicines under the pharmaceutical Act."
9. Express 84 as follows: "84. Health inspections at least once a year, the checks are carried out in pharmacies that have special permission (license) the General type of pharmacies (operation) to open or closed pharmacy opening (transaction) with special operating conditions, the medicine."
10. Make 91 as follows: "91. If the test finds that the pharmacy made the quality of medicinal products does not comply with the technical documentation requirements (e.g. pharmacopoeia in terms of technical) requirements, health inspection on it within three days in writing to the pharmacy. Pharmacy manager identifies the quality of medicinal causes of non-compliance and implement measures to prevent and to prevent future such violations, as well as in writing one month inform the health inspection of the measures taken. If the quality of the product is affected by the raw material quality, not a pharmacy manager shall ensure that withdrawn from these raw materials the pharmacy made medicines. "
11. Replace paragraph 97, first sentence, the words "the program or course learning" with the words "the program or course of study learning."
12. Add to the informative reference to European Union directive to point 7 by the following: ' 7) the European Parliament and of the Council of 27 January 2003 of Directive 2002/98/EC setting standards of quality and safety for human blood and blood components collection, testing, processing, storage and distribution, as well as amending Directive 2001/83/EC. '
13. Express 4. point 2 of the annex by the following: "2. The pharmacy for purified water test results log date no PO box (it's also the number of analysis) test results the assessment Test in their name, and the signature of the sulfātjon hlorīdjon in the calcium and magnesium ions of ammonium ion in red cētāj substances 1 2 3 4 5 6 7 8 9" Prime Minister i. Godmanis Health Minister i. Morris Editorial Note: regulations shall enter into force by august 9, 2008.