Cabinet of Ministers Regulations No. 448 in 2003 (12 august. No 44, § 11) amendments to the Cabinet of Ministers of 12 December 2000, in Regulation No 432 "production and control of medicinal products" Issued in accordance with article 5 of the law on Pharmacy (1) and (3) and article 19 to make a Cabinet of 12 December 2000, in Regulation No 432 "production and control of medicinal products" (Latvian journal, 2000, 454./457.nr.) the following amendments: 1. Replace the text of the provisions: 1.1., the words "Ministry of welfare" (fold) with the words "Ministry of health" (fold);
1.2. the word "application" (the fold) with the word "submission" (fold);
1.3. the word "applicant" (fold) with the word "applicant" (fold).
2. Express 3.3 subparagraph by the following: "3.3. company has posted at least one officer that rule 13.1 and 13.3. requirements referred to enforcement, which qualification (education and experience) meets the requirements set out in these regulations and is certified with the national pharmaceutical inspection approval."
3. Replace the words "in point 6.3 or outer packaging" with the words "primary or secondary packaging".
4. Express 7.3. subparagraph by the following: "7.3. the company has a designated officer whose qualifications and professional experience meets the requirements of these regulations;".
5. Delete paragraph 9.5., the words "the Minister approved of prosperity".
6. Replace paragraph 12, the word "import" with the word "imported".
7. the title of chapter II be expressed as follows: "II. Officers qualifications and professional experience requirements".
8. Put the following in paragraph 14: "14. Drug manufacturer provides to the company designated officers qualifications and professional experience match the requirements set out in these provisions and should be certified with the national pharmaceutical inspection approval. If a special permit (license) holder or applicant shall comply with the provisions of paragraph 15 of the said conditions, he may himself take responsibility and perform the duties of the officials. "
9. Make a point 15 as follows: introductory "15. Officer meet the following minimum qualifications and professional experience:".
10. Express section 15.3 as follows: "15.3. no less than two years of work experience in one or more of manufacturing enterprises in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances, testing and checking necessary to ensure the quality of medicinal products. Work experience can be less than one year, if the University studies of at least five years, and about a year and a half less, if they lasted for at least six years. "
11. the express section 18.2.7. following: 18.2.7. "sampling of raw materials (medicinal products used for the production of any substance except packing material) and packing materials (each material used in the packaging of medicinal products, with the exception of secondary containers for transport and delivery. Packing material depending on contact with the product are divided into primary and secondary); ".
12. Supplement with 18.2.13 18.2.15 18.2.14.,.,., and 18.2.16. subparagraph by the following: "qualifying 18.2.13. and validation;
18.2.14. evaluation, carried out by the responsible official, and drug production series distribution (output);
18.2.15. parametric output;
18.2.16. active substance production. "
13. Add to subparagraph 25.2. behind the words "for any failure" with the words "(the day after the capture of the fact) or complaint (immediately after you receive it)."
14. Express 25.3. subparagraph by the following: "creates a permanent and 25.3. an effective system to ensure timely drug withdrawal, and withdrawal from the market, as well as inform the public about the pharmaceutical inspection product destruction, recycling or other action, finding quality products;".
15. Supplement with 25.9. subparagraph by the following: "16.1. State Pharmacy Inspectorate informed of any changes in drug production facilities, as well as for the active substance, the primary packaging and printed material switching."
16. paragraph 30 expressing the following: "30. If a product required for issue of the certificate for the production and control of medicinal products or medicinal products of conformity assessment, with assessment and management related costs shall be borne by the controlled person. "
17. Delete paragraphs 32 and 40.
18. Make 42 as follows: "42. The Person who performs the duties of officials up to the date of entry into force of the provisions, but whose qualifications and professional experience do not meet the requirements laid down in these rules, shall have the right to continue these duties of the company concerned."
19. Delete paragraph 44.
20. Delete 45.2 in the words and figures "up to 1 January 2003".
21. Delete paragraph 49.
22. Supplement with an informative reference to European Union directives as follows: "Informative reference to European Union directives, the regulations include provisions arising from the Directive 2001/83/EC and 91/356/EEC."
Prime Minister e. Repše Health Minister i. Cricket is the Editorial Note: rules shall enter into force on 16 august 2003.