Cabinet of Ministers Regulations No. 447 in Riga in 2003 (12 august. No 44, § 7) amendments to the Cabinet of Ministers on 27 February 2001, Regulation No 88 of "medicine import, export and distribution rules" Issued in accordance with article 5 of the law on Pharmacy (1) and (3) and article 19 to make a Cabinet of 27 February 2001, Regulation No 88 of "medicine import, export and distribution rules" (Latvian journal, 2001, 35, 52 no) the following amendments: 1. Replace the text of the provisions: 1.1., the words "the Minister of welfare" (fold) with the words "Minister of health" (fold);
1.2. the words "Ministry of welfare" (fold) with the words "Ministry of health" (fold);
1.3. the word "application" (the fold) with the word "submission" (fold);
1.4. the word "applicant" (fold) with the word "applicant" (fold).
2. Delete paragraph 2, the words "with the exception of the pharmaceutical law, article 10, paragraph 7, and article 20 of the above cases".
3. To supplement the provisions under point 2.1, the following: "2.1 is not permitted to distribute a product according to the centralised procedure for registration is to be recorded in the European Agency for the evaluation of medicinal products, but which are not authorised in accordance with Regulation 2309/93/EEC."
4. Replace the words "in paragraph 7.2 direct or outer packaging" with the words "primary or secondary packaging".
5. Replace the words "paragraph 8.1 on the outer packaging" with the words "to the secondary packaging".
6. Delete paragraph 10.3., the words "and" pharmaceutical products ".
7. Make the following paragraph 26.3. "this is exempt from 26.3. rule 26.1. the obligation referred to in paragraph a, if between the European Community and the exporting country has concluded mutual recognition of conformity assessment of the agreement on good manufacturing practice for medicinal products and if the exporting State has made this rule 26.1. referred to in control."
8. Replace the words "in paragraph 21.4. the immediate and outer packaging" with the words "primary and secondary packaging".
9. Add to paragraph 64 of the third and fourth sentence as follows: "the State Agency of medicines has the right to health reasons in exceptional cases decide (in coordination with the Health Minister) on the issue of the distribution of the wholesale distribution of medicinal products, if the period of validity of the medicinal product is lower than the above, but the product is essential to the healing process, designed for the treatment of rare diseases or distributed in limited quantities. The responsibility for the disposal of unused medicinal products bears the medicine supplier. "
10. Express 68 the second sentence by the following: "expenditure relating to the testing of samples of medicinal products pursuant to compulsory quality control, shall be borne by the drug dealer whose samples of medicinal products subject to control."
11. the introductory part of paragraph 108 Deleted the words "(all or individual production series)".
12. Supplement with 108.1 points as follows: "the State Pharmaceutical inspection 108.1 is entitled to take a decision on the prohibition of the supply of medicinal products or the products of a series of withdrawals from the market, which is the object of the dispute."
13. Replace the words "113.5 in outer packaging" with "secondary package".
14. Make the following subparagraphs 125.2.: "125.2. fax machines (except pharmacies, where the receiving and sending e-mail with other technical means);".
15. Delete paragraph 139 in the name and the number "and 26".
16. Make the following paragraph 146: "146. Latvia is prohibited to distribute medicines which have not been manufactured in accordance with good manufacturing practice for medicinal products requirements."
17. To supplement the provisions of this paragraph 147: "147. Rule 2.1, 26 and 146. entry into force shall be determined by specific Cabinet rules."
18. To supplement the rules with the informative reference to European Union directives as follows: "Informative reference to European Union Directive provisions included in the law arising from Directive 2001/83/EC."
Prime Minister e. Repše Health Minister i. Cricket is the Editorial Note: rules shall enter into force on 16 august 2003.